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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 from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
17 Aug-20 Aug 1971
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Original report not available and documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Principles of method if other than guideline:
To assess the skin irritation potential of the test substance, it was applied to the shaved intact or abraded skin of animals (species not reported). The treated skin areas were observed for erythema and edema 24 and 72 hours after administration of the test substance. Only the intact skin was taken into account for assessment of the skin irritation potential of the test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): [trade name]
- Physical state: clear, yellow liquid
- Analytial purity: 100%
- Lot/batch No.: 9072C

Test animals

Species:
other: no data
Strain:
other: not further specified

Test system

Type of coverage:
not specified
Preparation of test site:
other: shaved intact or abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin served as the control
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
To assess the skin irritation potential of the test substance, it was applied to the shaved intact or abraded skin of animals (species not reported). The treated skin areas were observed for erythema and edema 24 and 72 hours after administration of the test substance. Only the intact skin was taken into account for assessment of the skin irritation potential of the test substance.

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 and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24 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 and 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
other: mean over 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
Well-defined erythema was observed on the treated intact skin areas in 2/3 animals 24 hours after exposure ended. One of the treated skin areas exhibited a greater degree of erythema at the 72-hour reading time point, while the effect was completely reversed in the other animal. No erythema was observed in 1/3 animals at the 24- as well as the 72-hour reading time point. No edema was noted at any reading time point.

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