Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: well performed research study, conducted prior to OECD and GLP guideline implementation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Method for primary irritation, Department of transportation act
Deviations:
not specified
GLP compliance:
no
Remarks:
(conducted prior to GLP implementation)

Test material

Constituent 1
Chemical structure
Reference substance name:
2',4'-dimethylacetoacetanilide
EC Number:
202-576-0
EC Name:
2',4'-dimethylacetoacetanilide
Cas Number:
97-36-9
Molecular formula:
C12H15NO2
IUPAC Name:
2',4'-dimethylacetoacetanilide
Details on test material:
- Name of test material (as cited in study report): Acetoacet-m-Xylidide

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved intact and shaved abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0.5 ml for liquids, 0.5 g for solids
Duration of treatment / exposure:
4 hrs exposure
Observation period:
4, 24, 48 hrs after initial application, after first reading test sites were washed
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animal # 2, 3, 5, 6 each
Time point:
other: mean of 4, 24, 48 h
Score:
0
Reversibility:
fully reversible
Remarks:
no effects at any time
Remarks on result:
other: shaved abraded
Irritation parameter:
erythema score
Basis:
other: animal # 1, 4 each
Time point:
other: mean of 4, 24, 48h
Score:
0.3
Reversibility:
fully reversible within: 24h
Remarks on result:
other: shaved abraded
Irritation parameter:
erythema score
Basis:
other: animal # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of 4, 24, 48h
Score:
0
Reversibility:
fully reversible
Remarks:
no effects at any time
Remarks on result:
other: shaved intact
Irritation parameter:
edema score
Basis:
other: animal # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of 4, 24, 48h
Score:
0
Reversibility:
fully reversible
Remarks:
no effects at any time
Remarks on result:
other: shaved itact and shaved abraded

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test substance is neither skin irritating nor skin corrosive in this test.
Executive summary:

The test item was tested for its skin irritating or skin corrosive properties according to the method for primary irritation of the Department of transportation act. Important aspects of this method (dosing, grading criteria) are in line with the current OECD guidelines. The fact, that the test substance was possibly not wetted (no data), is acceptable, because skin abrasion and occlusive covering cause similar test conditions.

Following this protocol 500 mg of the test item was applied to the shaved intact and shaved abraded skin of 6 albino rabbits. After four hours exposure time the occlusive covering was removed and the animals were examined for signs of skin irritation or corrosion. Following this, the test sites were washed. Readings were made again at 24 and 48 h after initial application. Mean scores (mean of 4, 24, 48 h) were calculated for oedema and erythema for each rabbit.

All calculated mean scores were 0 except for two rabbits whose mean score for erythema (shaved abraded) amounts to 0.3 but was fully reversible within 24h. Based on these findings the test substance is neither skin irritating nor skin corrosive in this test.