Alcohols, C8-18, 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:

Final report on the safety assessment of Nonoxynol

Author:

Cosmetic Ingredient Review Expert Panel

Year:

1983

Bibliographic source:

JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY, 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 the test chemical in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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

Test material form:

liquid

Details on test material:

- Name of test material: 4-Nonylphenol, ethoxylated
- Common Name: Nonoxynol -2
- 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 undiluted test chemical

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

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The Primary Irritation Index for the test chemical was 3.7 after 24hours.
Based on the scores, the test chemical 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 the test chemical in rabbits.

Single dose of 0.005,0.02, 0.10, or 0.5 ml of undiluted test chemical 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 for the test chemical was 3.7 after 24hours.

Based on the scores, the test chemical was considered to be minimal irritant to rabbit eyes.