Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
12.05.81
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
New Zealand white rabbits (KFM-NZW), 3 males

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: distilled water
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Observation period:
no data
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema/eschar
Basis:
animal #1
Time point:
other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
other: erythema/eschar
Basis:
animal #2
Time point:
other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
other: erythema/eschar
Basis:
animal #3
Time point:
other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: calculated on the basis of the scores at 24, 48 and 72 hours for each animal
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 3 d
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
other: edema/eschar
Basis:
mean
Time point:
other: 24-72h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 3 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 3 d

Any other information on results incl. tables

Comments: 4105 SKIN IRR

RESULT: Non-irritant. Maximum grading = 1.

Not classified as skin irritant

Changes fully reversible within 3 days

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The value of the scores for erythema and edema was 0 in all animals. The substance is not classified as irritating or corrosive to the skin.
The test substance can be classified as non-irritant according to the EEC directive No. 83/467/1983 in albino rabbits