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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
153812-94-3
Test material form:
liquid
Details on test material:
Name of the test substance used in the study report: Beta-Formylcrotonsaeuremethylester
Purity: > 95%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
Acclimatization period: at least 8 days before study start
One animal per cage (type: stainless steel with wire mesh walk floors; floor area: 40 x 51 cm).
Animal identification via ear tattoo.
They were housed in fully air-conditioned rooms with a room temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h darkness.
The animals were offered a standardized animal laboratory diet (ca. 130 g/animal/day) as well as tap water (ca. 250 ml/animal/day).

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hour
Observation period:
15 days
Number of animals:
3
Details on study design:
Clipping of the fur: at last 15 hours before test substance application
Application area: 2.5 x 2.5 cm
Application site: upper third of the back or flanks
Readings: 30 - 60 min after removal of the test patches and 24 h, 48 h, 72 h, 8 and 15 days after beginning of application
Assessment according to 83/467/EEC criteria )29 July, 1983)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 4h application
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 4h application
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: 4h application
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: 4-hour application
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: 4-hour application
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: 4-hour application

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria