ifra standards booklet - 47th amendment

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  • IFRA Standards

  • 46th Amendment IFRA STANDARD

    1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)ethan-1-one

    IFRA Standard 1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)ethan-1-one June 20, 2011 1/2

    CAS N: 13144-88-2 Empirical formula:

    Strucutre:

    C12H20O

    O

    Synonyms: 2-Acetyl-1,3,3,4,4-pentamethyl-1-cyclopentene Ethanone, 1-(2,4,4,5,5-pentamethyl-1-cyclopenten-1-yl)- 1-(2,4,4,5,5-Pentamethylcyclopent-1-en-1-yl)ethanone

    Alpinone (trade name)

    History: Initial reviews: New Standard

    Current revision date: June 20, 2011

    Implementation date: For new submissions*: August 20, 2011

    For existing fragrance compounds*: August 20, 2012

    Next review date 2016 * This date applies to the supply of fragrance compounds (formulas) only, not to the finished products in the marketplace.

    RECOMMENDATION: RESTRICTED

    RESTRICTIONS:

    Limits in the finished product:

    Category 1 See Note box (1) 0.03 % Category 7 0.08 %

    Category 2 0.04 % Category 8 1.01 %

    Category 3 0.15 % Category 9 5.00 %

    Category 4 0.45 % Category 10 2.50 %

    Category 5 0.24 % Category 11 See Note Box (2)

    Category 6 0.72 %

    Note box:

    (1) See the IFRA Code of Practice (Appendix 8, Introduction to the IFRA Standards) regarding the Note on Oral Care Products and other products with the potential of ingestion. (2) Category 11 includes all non-skin contact or incidental skin contact products. Due to the negligible skin contact from these types of products there is no justification for a restriction of the concentration of this fragrance ingredient in the finished product.

    Fragrance material specifications: N/A

    CONTRIBUTION FROM OTHER SOURCES:

    None known at the time of the publication of the Standard

    CRITICAL EFFECT: SENSITIZATION

  • 46th Amendment IFRA STANDARD

    1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)ethan-1-one

    IFRA Standard 1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)ethan-1-one June 20, 2011 2/2

    RIFM SUMMARIES:

    LLNA weighted mean EC3 values

    (g/cm2)

    [no. studies]

    Potency

    Classification

    Based on Animal Data1

    Human Data

    WoE

    NESIL3

    (g/cm2)

    NOEL

    HRIPT

    (induction)

    (g/cm2)

    NOEL HMT

    (induction)

    (g/cm2)

    LOEL2

    (induction)

    (g/cm2)

    3600 [1] Weak NA NA NA 1000

    All data in this Table are available from RIFM and are listed in the RIFM Database. NOEL = No observed effect level; HRIPT = Human Repeat Insult Patch Test; HMT = Human Maximization Test; LOEL = lowest observed effect level; NA = Not Available. 1Based on animal data using classification defined in ECETOC, Technical Report No. 87, 2003.

    2Data derived from HRIPT or HMT.

    3WoE NESIL limited to two significant figures.

    REXPAN RATIONALE / CONCLUSION:

    The RIFM Expert Panel reviewed the critical effect data for 1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)ethan-1-one and, based on the weight of evidence, established the No Expected Sensitization Induction Level (NESIL) as 1000 g/cm

    2, which is a default value based on the LLNA data. They recommend the limits for the 11 different product

    categories, which are the acceptable use levels of 1-(2,4,4,5,5-Pentamethyl-1-cyclopenten-1-yl)ethan-1-one in the various product categories. These were derived from the application of the exposure-based quantitative risk assessment approach for fragrance ingredients, which is detailed in the publication by Api et al., 2008.

    REFERENCES:

    Api AM, Basketter DA, Cadby PA, Cano M-F, Ellis G, Gerberick G, et al. Dermal Sensitization Quantitative Risk Assessment (QRA) For Fragrance Ingredients. Regulatory Toxicology and Pharmacology 2008;52(1): 3-23.

  • 44th Amendment IFRA STANDARD

    1-(5,5-Dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one

    IFRA Standard 1-(5,5-Dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one October 14, 2009 1/2

    CAS N: 56973-85-4 Empirical formula:

    Structure:

    C13H20O

    Synonyms: -Dynascone 4-Penten-1-one, 1-(5,5-dimethyl-1-cyclohexen-1-yl)-

    Galbascone

    History: Initial reviews: New Standard

    Current revision date: 2009

    Implementation date: For new submissions*: August 7, 2009

    For existing fragrance compounds*: August 7, 2011

    Next review date 2014

    * This date applies to the supply of fragrance compounds (formulas) only, not to the finished products in the marketplace.

    RECOMMENDATION: RESTRICTED

    RESTRICTIONS:

    Limits in the finished product:

    Category 1 See Note box (1) 0.07 % Category 7 0.19 %

    Category 2 0.09 % Category 8 2.00 %

    Category 3 0.38 % Category 9 5.00 %

    Category 4 1.13 % Category 10 2.50 %

    Category 5 0.60 % Category 11 See Note Box (2)

    Category 6 1.81 %

    Note box:

    (1) IFRA would recommend that any material used to impart perfume or flavour in products intended for human ingestion should consist of ingredients that are in compliance with appropriate regulations for foods and food flavourings in the countries of planned distribution and, where these are lacking, with the recommendations laid down in the Code of Practice of IOFI (International Organisation of the Flavor Industry http://www.iofiorg.org/) (2) Category 11 includes all non-skin contact or incidental skin contact products. Due to the negligible skin contact from these types of products there is no justification for a restriction of the concentration of this fragrance ingredient in the finished product.

    Fragrance material specifications: N/A

    CONTRIBUTION FROM OTHER SOURCES:

    None to consider (see also the note on contributions from other sources in the Introduction to the IFRA Standards)

    CRITICAL EFFECT: SENSITIZATION

  • 44th Amendment IFRA STANDARD

    1-(5,5-Dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one

    IFRA Standard 1-(5,5-Dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one October 14, 2009 2/2

    RIFM SUMMARIES:

    LLNA weighted mean EC3 values

    (g/cm2)

    [no. studies]

    Potency

    Classification

    Based on Animal Data2

    Human Data

    WoE

    NESIL3

    (g/cm2)

    NOEL

    HRIPT

    (induction)

    (g/cm2)

    NOEL HMT

    (induction)

    (g/cm2)

    LOEL1

    (induction)

    (g/cm2)

    745 [1] 4-5 Moderate 2500 NA NA 2500

    All data in this Table are available from RIFM and are listed in the RIFM Database. NOEL = No observed effect level; HRIPT = Human Repeat Insult Patch Test; HMT = Human Maximization Test; LOEL = lowest observed effect level; NA = Not Available.

    1 Data derived from HRIPT or HMT.

    2 Based on animal data using classification defined in ECETOC, Technical Report No. 87, 2003.

    3 WoE NESIL limited to two significant figures.

    4 EC3 value from one LLNA, not the mean.

    5 LLNA used a very wide spacing of doses. Based on the response at each dose the EC3 value would be slightly on the low side.

    The response in the LLNA was: 0.1% SI of 0.9 1.0% SI of 0.9 10% SI of 10.4 100% SI of 17.5

    REXPAN RATIONALE / CONCLUSION:

    The RIFM Expert Panel reviewed the critical effect data for 1-(5,5-Dimethyl-1-cyclohexen-1- yl)pent-4-en-1-one and, based on the weight of evidence, established the No Expected Sensitization Induction Level (NESIL) as 2500 mg/cm2. They recommend the limits for the 11 different product categories, which are the acceptable use levels of 1-(5,5-Dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one in the various product categories. These were derived from the application of the exposure-based quantitative risk assessment approach for fragrance ingredients, which is detailed in the QRA Expert Group Technical Dossier of June 22, 2006.

    REFERENCES:

    RIFM (Research Institute for Fragrance Materials, Inc.), 1999. Human repeated insult patch test. Unpublished study from Firmenich Inc., 29a June. Report number 42138. (RIFM, Woodcliff Lake, NJ, USA). RIFM (Research Institute for Fragrance Materials, Inc.), 2001a. Local Lymph Node Assay. Unpublished study from Givaudan, 16 May. Report number 42073. (RIFM, Woodcliff Lake,NJ, USA). RIFM (Research Institute for Fragrance Materials, Inc.), 2001b. Human repeated insult patch test. Unpublished study from IFF Inc., 29 October. Report number 51118. (RIFM, Woodcliff Lake, NJ, USA).

  • 44th Amendment IFRA STANDARD

    1,2,3,4-Tetrahydro-4-methylquinoline

    IFRA Standard 1,2,3,4-Tetrahydro-4-methylquinoline October 14, 2009 1/1

    CAS N: 19343-78-3 Empirical formula:

    Structure:

    C10H13N

    Synonyms: 4-Methyl-1,2,3,4-tetrahydroquinoline Quinoline, 1,2,3,4-tetrahydro-4-methyl- 1,2,3,4-Tetrahydrolepidine

    1,2,3,4-Tetrahydro-4-methylquinoleine

    History: Initial reviews: New Standard

    Current revision date: 2009

    Implementation date: For new submissions*: August 7, 2009

    For existing fragrance compounds*: August 7, 2010

    Next review date 2014 * This date applies to the supply of fragrance compounds (formulas) only, not to the finished products in the marketplace.

    RECOMMENDATION: PROHIBITED

    RESTRICTIONS:

    Limits in the finished product:

    Skin contact products:

    Leave on products: N/A Rinse-off products: N/A

    Including household cleaning products

    Non skin contact products: N/A

    Note box:

    The material has been identified for having the potential of forming nitrosamines in nitrosating systems. Downstream users therefore have to be notified of the presence of the material and its potential to be able to consider adequate