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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
Study period:
11 - 18 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Occlusive exposure, analytical purity of test substance not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive exposure
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): isononanoate cetearyle
- Physical state: transparent liquid
- Analytical purity: no data
- Lot/batch No.: 0510 C

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Jègard
- Weight at study initiation: 2.868 kg (mean)

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required, untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was not washed after the 4-hour exposure period

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
Very slight erythema (score 1) was observed in 2/3 rabbits 1 hour after exposure ended, and persisted in 1/3 rabbits up to and including the 72-hour reading time point (see Table 1). 1/3 animals had very slight oedema from the 1-hour reading time point up to and including the 48-hour reading time point. All irritiation effects had cleared completely within 7 days.
Other effects:
At the 72-hour reading time point, dry skin was noted at the test site in the rabbit that also showed very slight erythema.

Any other information on results incl. tables

Table 1: Individual skin irritation scores

 

Observation time

Rabbit No.

 

1

2

3

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

0

0

1

1

1

0

24 h

0

0

0

1

1

0

48 h

0

0

0

1

1

0

72 h

0

0

0

0

1

0

7 days

0

0

0

0

0

0

Mean value 24 + 48 + 72 h

0

0

0

0.66

1

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified