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Toxicological information

Eye irritation

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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:
1983
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, Volume 2, Number 7, 1983

Materials and methods

Test guideline
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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
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.