Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of the test substance used in the study report: Acryloxibutylchlorformiat
- Purity: ca. 75%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Young adult animals were used (mean body weight male animals: 3.53 kg, mean body weight female animal: 3.38 kg).
One animal per cage (type: stainless steel wire mesh cages with grating, floor area 3000 cm2). The animals were identified 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 dark.
The animals were offered a standardized animal laboratory diet (about 130 g/animal/day) as well as tap water (about 250 ml/animal/day).
Acclimatization period: at least one week

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
The test patches (2.5 x 2.5 cm) were moistened with a dose of 0.5 ml of the test substance.
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3
Details on study design:
At least 24 hours before study start, the fur was removed by clipping the dorsal of the trunk of the animals. Only animals with healthy intact skin have been used.
Weight determination: shortly before test substance application
The test substance was applied in a single dose to the intact untreated skin. The test patches were secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol and Lutrol/water (1:1).
Application site: upper third of theback or flanks
Readings: 1 h, 24 h, 48 h, 72 h, 8 d and 15 d after removal of the test patches.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
3.9
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 15 d
Irritant / corrosive response data:
The skin findings were reversible in 2 animals within 15 days after removal of the test patches, while scaling was still present. The finding observed in one animal was not considered to be reversible.

Applicant's summary and conclusion