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:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
24 h exposure, no scoring at 48 h
GLP compliance:
no
Remarks:
GLP was not mandatory at time of study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Remarks:
no scoring at 48 h
Time point:
24/48/72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
no scoring at 48 h
Time point:
24/48/72 h
Score:
0.08
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
GDMA is not irritating to skin. The deficiency of the study (no 48-h score) is more than compensated by the longer exposure time (24 instead of 4 h) and the occlusive exposure conditions.