Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16th July 1991 - 3rd December 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: 9059

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test material, a colourless liquid, was stored in the dark under ambient conditions.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Manston Road, Margate, Kent
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 171-216 g
- Fasting period before study: Yes; overnight prior to dosing and 3 h post dosing
- Housing: polypropylene cages with mesh floors suspended over absorbent paper lined trays, with a maximum of 5 animals per cage.
- Diet: Rat and Mouse No. 1 Maintenance Diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex, CM8 3AD ad libitum
- Water: Tap water ad libitum
- Acclimination: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C mean relative humidity was 55%.
- Humidity (%): Mean relative humidity was 55%
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Rats were prepared by clipping the backs free of hair, approximately 24 h before application of the test material. Care was taken to avoid abrading the skin. The test material was applied evenly onto a gauze dressing which was applied to the shaved back of each rat.
- % coverage: 10%
- Type of wrap if used: Strip of non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin wiped with a water dampened tissue to remove excess test material.
- Time after start of exposure: 24 hrs
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: The rats were observed frequently on the day of dosing and once daily for 14 days following dosing
- Frequency of observations and weighing: They were weighed immediately prior to dosing, 7 days after dosing and at sacrifice at the end of the 14 day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no mortalities.
Clinical signs:
There were no clinical signs.
Body weight:
Body weight gains were acceptable.
Gross pathology:
No abnormalities were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute dermal toxicity study in Sprague-Dawley rats, the LD50 (male/female) was >2000 mg/kg bw.
Executive summary:

In an acute dermal toxicity study (8279), groups of Sprague-Dawley rats (5/sex) were dermally exposed (10% body surface area; occlusive) to 1,2-Diethoxypropane for 24 hours. The substance was removed after 24 hrs with washing. Animals were then observed for 14 days.

Dermal LD50 (Males/Females) = >2000 mg/kg bw

There was no mortality and no clinical signs were noted. No abnormalities were detected at necropsy. Body weight gains were acceptable.