Registration Dossier

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given. Deficiencies: - occlusive dressing - two application sides (intact and abraded skin) - exposure period of 24 hours - examination of erythema and edema after 24/72 hours

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited data on animals and husbandry - occlusive dressing - two application sides (intact and abraded skin) - exposure period of 24 hours - examination of erythema and edema after 24/72 hours)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
No details.

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2 kg
- Housing: singly
- Diet (ad libitum): NAFAG rabbit food
- Water (ad libitum): drinking water

Test system

Type of coverage:
occlusive
Preparation of test site:
other: left flank: shaved and abraded; right flank: shaved
Vehicle:
other: polyethylene glycol
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 male and 3 female animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded side of the test animals
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded side of the test animals

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information