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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
O.5 g of substance was applied to the skin of 5 guinea pigs for 24 hours under an occlusive dressing.
GLP compliance:
no
Remarks:
However was subject to Quality Assurance

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
guinea pig
Strain:
other: Cr1:(HA) BR Hartley

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
Moistened with water
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hours
Observation period:
15 days
Number of animals:
5 Females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 15 days
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
No signs of irritation were observed over the 15 day observation period

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria (Reg 1272/2008) are not met
Conclusions:
HQEE was not irritating to guinea pig skin.