Registration Dossier

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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
groups of three rats were dermally exposed to 1g/rat of the test substance to assess dermal acute toxicity and irritation potential.
GLP compliance:
no
Remarks:
GLP not implemented at the time of study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Batch RJ1173

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
glaxo colony
Details on test animals and environmental conditions:
Male rats
weights 290-413g
housed singly

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
3.4 g/kg (1g/rat)
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
3 animals per test group

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met