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Toxicological information

Skin irritation / corrosion

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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:
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 skin 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

Species:
rabbit
Strain:
not specified
Details on test animals 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.