Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-20-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented, scientifically acceptable study report

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Principles of method if other than guideline:
according to BASF-internal standard
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Source: Firma Gaukler, Offenbach am Main, Germany
Acclimatization period: at least 8 days before study start
Mean body weight: 2.89 kg
Singly housing in stainless steel wire mesh cages (floor area: 40 x 51 cm).
Room temperature: 20 - 26 °C
Relative humidity: 50 - 80 %
Day/night rhythm: 12 h light and 12 h darkness
The animals were identified via ear tattoo.
The animals were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 mL/animal/day).

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
3 minutes and 4 h
Observation period:
8 days
Number of animals:
2
Details on study design:
Clipping of the fur: at least 15 hours before application
Application area: 2.5 x 2.5 cm
Application site: upper third of the back
After application, the test substance was washed off with Lutrol and Lutrol/water (1:1).
Scoring according to Draize, 1959
Readings: 15 - 30 minutes after removal of the test patches and 24 h, 48 h and 8 days after application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: exposure time: 3 min
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: exposure time: 3 min
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48 h
Score:
1.75
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: exposure time: 4 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: exposure time: 4 h

Any other information on results incl. tables

Exposure time

Scoring time

Animal

Erythema score

Edema score

3 min

24 h

1

0

0

2

0

0

48 h

1

0

0

2

0

0

8 days

1

0

0

2

0

0

4 h

24 h

1

1

0

2

3

3

48 h

1

1

1

2

2

2

8 days

1

0

0

2

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information GHS, UN CAT 3
Conclusions:
The skin irritation of the test substance was assesed in rabbits and a slight irritation potential was found.
Executive summary:

The test substance was applied to shaved skin of rabbits under occlusion for 3 min and 4 h. After 3 min no irritation was detected. After 4 h a mean erythema score of 1.75 (of 4) was observed and an edema of 1.5 (of 4) for 24 - 48 h after exposure. The effects were fully reversible within 8 days.