Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Hacking & Churchill ltd., Huntingdon, UK
- Weight at study initiation: average 3 kg
ENVIRONMENTAL CONDITIONS
- Diet: mümmel Z 222 (Hoeing Kraftfutterwerk Niedersachsen, Verden/Aller)
- Water: tap water (ad libitum)
- Temperature: 19 - 21 °C
- Humidity: 40 - 50 %
- Housing: 1 animal per cage
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: Lutrol (Polyethylene glycol)
Controls:
no
Amount / concentration applied:
500 mg in Lutrol (Polyethylene glycol)
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Coverage: gauze

After 4 hours of exposure the skin was washed with water.

SCORING SYSTEM:
- according to Draize
Scores for erythema and edema after 24 and 72 hours were averaged.
The sum of the average value divided by 2 results in the primary irritating index fot the skin.

Results and discussion

Applicant's summary and conclusion

Executive summary:

In a dermal irritation study (Bayer AG, 1982) 3 New Zealand White rabbits were dermally exposed to p-chlorobenzyl chloride in Lutrol (Polyethylene glycol). The test site (intact, shaved skin) was covered with gauze 4 hours. Rabbits then were observed for 7 days. Irritations regarding erythema and edema were scored according to the Draize system after 24 and 72 hours.

Skin irritation classified according to OECD Guideline 404: non-irritant