Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

EC Number:

285-089-6

EC Name:

Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

Cas Number:

85029-63-6

Molecular formula:

not applicable, mixture

IUPAC Name:

Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Strain: Hoe: WISKf (SPF71)
Origin: HOECHST AG, Kastengrund, SPF-Zucht
Average body weights: males 186.8 g (5 animals); females 187.2 g (5 animals)
Age of animals at test start: males: approx. 7 weeks, females: approx. 8 weeks

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

The test substance was dissolved at 37 °C in sesame oil and administered to the rats via gavage. The observation period was 14 days after administration of the test substance.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males, 5 females

Control animals:

no

Details on study design:

Symptoms after application of the test substance were recorded twice daily (before noon and afternoon), on weekends and holidays once daily. Within this time period, body weights of the animals were recorded once a week. Animals were sacrificed at the end of the observation period (14 days) with carbon dioxide, dissected and evaluated for mascroscopic changes.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities occurred

Mortality:

After the application of the test substance. during the 14-day observation period, no mortalities occurred.

Clinical signs:

other: No clinical signs observed during application and observation period.

Gross pathology:

No macroscopical changes were observed in the pathological examination of the test animals.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The LD50 (oral) of the substance is greater than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was assessed in a study according to OECD Guideline 401 with rats. As a result of the study, the LD50 (oral) was determined to be > 2000 mg/kg bw.