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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethyl-2-oxazoline
EC Number:
233-912-4
EC Name:
2-ethyl-2-oxazoline
Cas Number:
10431-98-8
Molecular formula:
C5H9NO
IUPAC Name:
2-ethyl-2-oxazoline
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
The animals were placed in individual holding cages with free access to food and water.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Acute percutaneous absorption toxicity was evaluated by application of 500 mg/kg of the active material as a 10% aqueous solution to the intact skin of 2 male and 2 female rabbits and 500 or 252 mg/kg to abraded skin on similar groups of rabbits. Twenty-four hours prior to application, the entire trunk of each rabbit was clipped free of hair with electric clippers. The material was applied under a heavy gauge plastic cuff which was held in place by rubber bands. The plastic cuff was covered with a cloth bandage taped securely to the marginal hair. After 24 hours the cuffs were removed, and the skin was washed with soap and water, rinsed thoroughly, and dried with a cloth towel.
Doses:
500 mg/kg (as a 10% aqueous solution) to intact skin
500 or 252 mg/kg to abraded skin
No. of animals per sex per dose:
2 males and 2 females per dose
Control animals:
no
Details on study design:
The topical response at the site of application was evaluated after removal of the plastic cuff. The animals were observed frequently during exposure and for the following two weeks for signs of toxicity. Body weights were recorded before and after the 24-hour exposure period and at 1 and 2 weeks post-treatment, or until pre-treatment weight was regained.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
test mat.
Mortality:
The 2 female rabbits from the 500 mg/kg group with abraded skin died 17 and 18 days after treatment.
Clinical signs:
The animals with intact skin exhibited slight to moderate redness and slight to severe swelling when the cuffs were removed; the animals with abraded skin, exhibited very slight redness and swelling (252 mg/kg group); and slight to severe redness with slight to moderate swelling (500 mq/kg group). One male and one female from the abraded 500 mg/kg group exhibited slight transient diarrhea, then the other female developed severe diarrhea prior to death.
Body weight:
All of the animals from the abraded skin group gained weight during the first week following treatment, then lost weight (0.12 to 0.47 kg) during the second week, and the 2 male rabbits required 2 more weeks to equal pre-treatment weight. The animals from the other groups regained pre-treatment weight in 1 - 2 weeks with all animals showing a weight gain during the second week.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
No deaths were reported following unabraded dermal exposure of 2 male and 2 female rabbits to 500 mg/kg bw active material presented as a 10% aqueous solution of ETOX.