Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

study report 26 Oct 1976 (no additional details)

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:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

3 animals per sex per dose; two doses

GLP compliance:

no

Remarks:

prior to GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane

EC Number:

701-135-4

Cas Number:

30499-70-8

Molecular formula:

C15H26O6;C15H22O5

IUPAC Name:

Reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

other: Tif: RAif (SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

Healthy random bred rats of the Tif: RAif (SPF) strain raised on our premises were used for these experiments.
They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 14 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 180 to 200 grams.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

During the treatment and observation period the rats were housed individually in Macrolon cages (type 2). Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square em was shaved with an electric clipper.
For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.

Duration of exposure:

24 hours

Doses:

2150 and 3170 mg/kg (No higher doses were possible)

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

Three anmals per sex per dose group. During the treatment and observation period the rats were housed individually in Macrolon cages. Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper. For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 170 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality

Mortality:

no mortalitily in any dose group

Clinical signs:

other: No symptoms and no local skin irritation were seen.

Gross pathology:

No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of the test material in rats of both sexes observed over a period of 14 days is greater than 3170 mg/kg .

Executive summary:

Healthy random bred rats of the Tif: RAif (SPF) strain were prepared for testing approximately 24 hours before treatment by shaving an area on the back of the rats of approximately 60 square cm with an electric clipper. The test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was cleaned with lukewarm water and the reaction of the skin was appraised.

No symptoms and no local skin irritation were seen. No mortalities occurred; no substance related gross organ changes were seen.

The acute dermal LD50 of the test material in rats of both sexes observed over a period of 14 days is greater than 3170 mg/kg bw.