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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions. Occlusive dressing and prolonged exposure period (24 h). No details on test animals and environmental conditions.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972
Reference Type:
secondary source
Title:
ECB IUCLID set dihexyl adipate
Author:
ECB
Year:
2000
Bibliographic source:
EUROPEAN COMMISION – European Chemicals Bureau
Report date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing and prolonged exposure period (24 h); no details on test animals and environmental conditions
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dihexyl adipate
EC Number:
203-757-7
EC Name:
Dihexyl adipate
Cas Number:
110-33-8
Molecular formula:
C18H34O4
IUPAC Name:
dihexyl adipate
Details on test material:
- Name of test material (as cited in study report): Di-m-Hexyl adipate
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
7 days
Reading time points: 1, 24, 48, 72, 120 h (5 days) and 168 h (7 days)
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: The test substance was applied on the skin under a one inch by one inch square patch (2.54 cm x 2.54 cm).
- Type of wrap if used: The patch was held in place with an adhesive tape and the trunk of each animal was wrapped with plastic stripes to retard evaporation.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 120 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 120 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 120 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
At the 1 h reading, no skin reactions were observed in the treated animals. Very slight to slight erythema and very slight edema were observed 24 and 48 h post-application, whereas only very slight erythema and no edema were noted at the 72 h reading time point. Erythema were fully reversible within 5 days after test substance application and no further reactions were observed after 7 days.
Other effects:
The sample had a slight defatting effect causing the skin to flake off in 7 to 10 days after application. There was no injury in depth.

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

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