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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Principles of method if other than guideline:
2 white New-Zealand rabbits were treated onto the inside of the ear with ca. 500 µl of the test substance. The test item remained under semiocclusion for 24 hours. After exposition the test substance was removed with water and soap/oliveoil. Treated animals were inspected for skin effects (erythema, oedema) after removal of plaster and after 2 days.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Butanal, reaction products with aniline
EC Number:
270-109-8
EC Name:
Butanal, reaction products with aniline
Cas Number:
68411-20-1
IUPAC Name:
aniline; butanal
Details on test material:
Vulkacit 576 = Butanal, reaction products with aniline

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
2 days
Number of animals:
2 animals (1 male + 1 female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 hr (after removal of plaster)
Score:
1.5
Max. score:
4
Reversibility:
other: no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 hr (after removal of plaster)
Score:
1.5
Max. score:
4
Reversibility:
other: no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
1.5
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 0 h (removal of plaster) and 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Remarks on result:
not measured/tested
Other effects:
no data

Any other information on results incl. tables

No edema was seen at 0 h (removal of test substance) and 48 hours

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

Two white New-Zealand rabbits were treated onto the inside of the ear with ca. 500 µl of the test substance. The test item remained under semiocclusion for 24 hours. After exposition the test substance was removed with water and soap/oliveoil. Treated animals were inspected for skin effects (erythma, oedema) after removal of plaster and after 2 days.

Erythema score after removal of the test substance by washing and after 48 hours was 1.5 of 4. No edema was seen.

Therefore a classification is not justified.