1,2-diethoxypropane

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-diethoxypropane

EC Number:

412-180-1

EC Name:

1,2-diethoxypropane

Cas Number:

10221-57-5

Molecular formula:

C7H16O2

IUPAC Name:

1,2-diethoxypropane

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 or test system 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:

other: There were no clinical signs.

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.