Registration Dossier
Registration Dossier
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EC number: 216-472-8 | CAS number: 1592-23-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males were treated 42 days and females were treated for 14 days prior to mating to day 3 of lactation
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 13 male and 13 female Sprague-Dawley rats per dose group
- Control animals:
- yes
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Treatment-related adverse effects observed in offspring
- Conclusions:
- NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
- Executive summary:
A summary of an OECD 422 combined repeat dose and reproductive toxicity study on behenic acid (C22) is available in the safety assessment of fatty acids report by the Cosmetics Ingredients Review expert panel (CIR 2018). The data have been included as a Klimisch 4 supporting study as very limited details are available, however the data are taken from a peer-reviewed secondary source and are considered relevant for inclusion.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- Published review document
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of test:
- males were treated 42 days and females were treated for 14 days prior to mating to day 3 of lactation
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 13 male and 13 female Sprague-Dawley rats per dose group
- Control animals:
- yes
- Details on results:
- NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
- Details on maternal toxic effects:
- NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- Details on embryotoxic / teratogenic effects:
- NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: Treatment-related adverse effects observed for offspring
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day
- Treatment related:
- not specified
- Conclusions:
- NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
- Executive summary:
A summary of a 28 day gavage study on behenic acid (C22) is available in the safety assessment of fatty acids report by the Cosmetics Ingredients Review expert panel (CIR 2018). The data have been included as a Klimisch 4 supporting study as very limited details are available, however the data are taken from a peer-reviewed secondary source and are considered relevant for inclusion.
NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Safety assessment of fatty acids and soaps as used in cosmetics
- Author:
- Cosmetics Ingredients Review Expert Panel
- Year:
- 2 018
- Bibliographic source:
- Scientific Literature Review for Public Comment, Cosmetic Ingredient Review, 1620 L St NW, Suite 1200, Washington, DC 20036-4702, USA
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Docosanoic acid
- EC Number:
- 204-010-8
- EC Name:
- Docosanoic acid
- Cas Number:
- 112-85-6
- Molecular formula:
- C22H44O2
- IUPAC Name:
- docosanoic acid
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males were treated 42 days and females were treated for 14 days prior to mating to day 3 of lactation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 13 male and 13 female Sprague-Dawley rats per dose group
- Control animals:
- yes
Results and discussion
Results of examinations
- Details on results:
- NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: treatment related effects in parental animals and offspring
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Applicant's summary and conclusion
- Conclusions:
- NOAEL >= 1000 mg/kg bw/day; no treatment-related adverse effects observed in parental animals or offspring
- Executive summary:
A summary of an OECD 422 combined repeat dose and reproductive toxicity study on behenic acid (C22) is available in the safety assessment of fatty acids report by the Cosmetics Ingredients Review expert panel (CIR 2018). The data have been included as a Klimisch 4 supporting study as very limited details are available, however the data are taken from a peer-reviewed secondary source and are considered relevant for inclusion.
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