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Registration Dossier
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EC number: 500-045-0 | CAS number: 26027-38-3 1 - 2.5 moles ethoxylated
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- 3 Final Report on the Safety Assessment of Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 1 983
- Bibliographic source:
- JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Volume 2, Number 7, 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Primary skin irritation test was carried out to assess the irritation potential of 4-Nonylphenol, ethoxylated in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-Nonylphenol, ethoxylated
- EC Number:
- 500-045-0
- EC Name:
- 4-Nonylphenol, ethoxylated
- Cas Number:
- 26027-38-3
- Molecular formula:
- (C2-H4-O)mult-C15-H24-O
- IUPAC Name:
- 4-Nonylphenol, ethoxylated
- Reference substance name:
- Nonoxynols
- IUPAC Name:
- Nonoxynols
- Test material form:
- liquid
- Details on test material:
- - Name of test material :4-Nonylphenol, ethoxylated
- Molecular formula : C17H28O2
- Molecular weight :264.406 g/mol
- Smiles notation : c1(ccc(OCCO)cc1)CCCCCCCCC
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material: 4-Nonylphenol, ethoxylated
- Molecular formula: C17H28O2
- Molecular weight: 264.406 g/mol
- Smiles notation: CCCCCCCCCc1ccc(OCCOCCO)cc1
- Substance type: Organic
- Physical state: Liquid
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- intact and abraded skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml undiluteed test chemical
- Duration of treatment / exposure:
- single exposure
- Observation period:
- 24,72 hours
- Number of animals:
- 6
- Details on study design:
- SCORING SYSTEM: The sites were individually examined at 24 h and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24- and 72-hours gradings were averaged to determine the Primary Irritation Index (PII).
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Moderately irritating
Any other information on results incl. tables
Table 1: Primary Skin Irritation
Nonoxynol |
Concentration (%) |
No. of rabbits |
Protocola |
PII or Gradeb |
Comment |
2 |
100 |
6 |
B |
2.0 |
Moderately irritating |
a- as described in the method
b- PII max = 8.00, Grade max = 10
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The Primary Irritation Index for 4-Nonylphenol, ethoxylated (Nonoxynol -2) was 2.0 after 24, 72 hours.
Based on the scores, 4-Nonylphenol, ethoxylated (Nonoxynol -2) was moderately irritating to rabbit skin. - Executive summary:
A Primary skin irritation test was carried out to assess the irritation potential of4-Nonylphenol, ethoxylated (Nonoxynol -2) in rabbits.
0.5 ml of undiluted test chemical was applied under occlusion to the clipped, intact and abraded skin of 6 rabbits and observed for signs of irritation.The sites were individually examined at 24 h and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24- and 72-hours gradings were averaged to determine the Primary Irritation Index (PII).
The Primary Irritation Index for 4-Nonylphenol, ethoxylated (Nonoxynol -2) was 2.0 after 24, 72 hours.
Based on the scores, 4-Nonylphenol, ethoxylated (Nonoxynol -2) was moderately irritating to rabbit skin.
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