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:
comparable to guideline study with acceptable restrictions
Remarks:
No GLP or OECD defined

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Principles of method if other than guideline:
500 µl N,N Dibenzylamine was applied to the skin of rabbits for 4 hours to evalutate the skin Irritation/corrosion potential of the test substance (no further data) .
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: purity 99.1 %

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- body weight: 3.6 kg
- no further data

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
500 µl
Duration of treatment / exposure:
4 h
Observation period:
14 d
Number of animals:
1
Details on study design:
Scoring according to Draize, 1h, 24 h, 48 h, 72 h, and 7 d, and 14 days post application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: skin appearance
Basis:
animal #1
Time point:
other: 7d, 14 d
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: squamous covering, induration of the skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
7 d
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
14 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
7 d
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
14 d
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Due to a severe skin irritation including non-reversible squamous covering and induration of the skin in the first tested animal, no further animals were tested dermally

Any other information on results incl. tables

Results (Exposition time: 4

                                  Draize Grade after     
 G11    Body weight  1h        24h     48h     72h     7d     14d     Irritation Index
  G11    3.6 kg  e  o  e  o  e  o  e  o  e  o  e  o  e  o
     3  3  3  2  3  1  3  1  3  1  3  1  3.0  1.3
                        f,g     f,g    

f = white flaked covering ; g = hardening

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The test substance was tested in one animal for its skin irritative/corrosive potential. Due to a severe skin irritation including non-reversible squamous covering and induration of the skin in the first tested animal, no further animals were tested dermally.
Based of the result of this study the N.N-Dibenzylamine was found to be corrosive to the skin (Bayer 1994).
Based on the criteria of the CLP regulation (EC) No 1272/2008, the test item should be classified for skin corrosion Category 1C.