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)
Rationale for reliability incl. deficiencies:
other: similar to respective guideline but reported only in brief

Data source

Reference
Reference Type:
other: short report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: powder
Details on test material:
IUCLID4 Test substance: :
pure technical product

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: oil
Controls:
other: the opposite side served as control
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Details on study design:
Single application of 500 mg of the substance moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: irritational effects: scarificed skin
Basis:
mean
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: irritational effects: intact skin
Basis:
mean
Time point:
other: up to 7 days
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
72 hours post application, only the scarificed area of both rabbits showed a marked reddening of the skin (scores not given) which were fully reversible within 7 days. No other irritating effects were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Single application of 500 mg Macrolex Rot EG moistened with oil, onto the shaved partly intact and partly scarificed back of each of 2 rabbits for 24 hours. The substance was held in place by a plaster. After removing of the plaster the animals were observed for up to 7 days. 72 hours post application , omly the scarificed area of both rabbits showed a marked reddening of the skin (score 2/4) which were fully reversible within 7 days. Intact skin showed no reaction. Therefore, Macrolex Rot EG is evaluated as non-irritant to the intact skin of rabbits