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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 eye 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 / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- sex: male and female
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Single dose of 0.005, 0.02, 0.10, or 0.5 ml of undiluted Nonoxynol 2
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- within 1 h unstained and at 24 h after fluorescein staining
1, 2, 3, 4 and 7 days post –instillation - Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6 (males and females)
- Details on study design:
- TEST SITE
- Area of exposure: conjunctival sac
REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed
SCORING SYSTEM: According to Draize method
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein:
Fluorescein staining was performed 1 hour after observation
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.7
- Max. score:
- 120
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- Minimal irritant
Any other information on results incl. tables
Table 1: Primary Eye Irritation
Nonoxynol |
Concentration (%) |
No. of rabbits |
Wash (Y/N) |
Average Score* (Draize) |
Comment |
||||
1 day
|
2 days
|
3 days
|
4 days
|
7 days
|
|||||
2 |
100 |
6 (M+F) |
N |
3.7 |
0.0 |
0.0 |
- |
- |
Minimally Irritating |
*- Maximum score = 120
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The Primary Irritation Index for 4-Nonylphenol, ethoxylated (Nonoxynol -2) was 3.7 after 24hours.
Based on the scores, 4-Nonylphenol, ethoxylated (Nonoxynol -2) was considered to be minimal irritant to rabbit eyes. - Executive summary:
A Primary eye irritation test was carried out to assess the irritation potential of 4-Nonylphenol, ethoxylated (Nonoxynol -2) in rabbits.
Single dose of 0.005,0.02, 0.10, or 0.5 ml of undiluted Nonoxynol 2 was instilled into the conjunctival sac of 6 (male and female) rabbits. The treated eyes remained unwashed throughout the test. The eyes were examined within 1 h unstained and at 24 h after fluorescein staining. The rabbits were observed for signs of irritation at 1, 2, 3, 4 and 7 days post –instillation of the test chemical. Thereactions observed were scored according Draize method.
The Primary Irritation Index for4-Nonylphenol, ethoxylated (Nonoxynol -2) was 3.7 after 24hours.
Based on the scores, 4-Nonylphenol, ethoxylated (Nonoxynol -2) was considered to be minimal irritant to rabbit eyes.
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