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

Endpoint summary

Description of key information

The oral LD50 in rats was > 2000 mg/kg bw in a reliable study.

There is no study on acute inhalation and dermal toxicity available. The acute inhalation study was waived in accordance with Annex XI No 1.2: no testing for acute toxicity after inhalations exposure has to be performed because there is sufficient evidence from existing studies that the substance is not acutely toxic up to the limit doses (e.g. acute oral toxicity study with LD50 > 2000 mg/kg; OECD 422 study: NOAEL 1000 mg/kg bw).

The acute dermal study was waived in accordance with Annex XI No 1.2: it is scientifically not necessary to perform an acute dermal toxicity study, because existing data indicate that it can be plausibly assumed that a dermal LD50 of > 2000 mg/kg would result based

- on the findings of an acute oral toxicity study in rats with a LD50 > 2000 mg/kg,

- on the findings of an OECD 422 study with oral application which did not reveal adverse effects up to the limit dose of 1000 mg/kg/d,

- on the plausible assumption that dermal absorption would not exceed oral absorption.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Reliable study with no adverse effects observed up to 2000 mg/bw/day, the highest dose tested

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The acute inhalation study was waived in accordance with Annex XI No 1.2: no testing for acute toxicity after inhalations exposure has to be performed because there is sufficient evidence from existing studies that the substance is not acutely toxic up to the limit doses (e.g. acute oral toxicity study with LD50 > 2000 mg/kg; OECD 422 study: NOAEL 1000 mg/kg bw).

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Justification for type of information:

In accordance with Annex XI No 1.2 it is scientifically not necessary to perform an acute dermal toxicity study, because existing data indicate that it can be plausibly assumed that a dermal LD50 of > 2000 mg/kg would result based
- on the findings of an acute oral toxicity study in rats with a LD50 > 2000 mg/kg,
- on the findings of an OECD 422 study with oral application which did not reveal adverse effects up to the limit dose of 1000 mg/kg/d,
- on the plausible assumption that dermal absorption would not exceed oral absorption.

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The acute dermal study was waived in accordance with Annex XI No 1.2: it is scientifically not necessary to perform an acute dermal toxicity study, because existing data indicate that it can be plausibly assumed that a dermal LD50 of > 2000 mg/kg would result based
- on the findings of an acute oral toxicity study in rats with a LD50 > 2000 mg/kg,
- on the findings of an OECD 422 study with oral application which did not reveal adverse effects up to the limit dose of 1000 mg/kg/d,
- on the plausible assumption that dermal absorption would not exceed oral absorption.

Additional information

Based on a reliable guideline study with rats the oral LD50 value is >2000 mg/kg.

There is no dermal acute toxicity study available, but based on the information from the acute oral study and the assumption that dermal absorption will not exceed oral absorption it can reasonably be assumed that an experimental dermal LD50 would also be > 2000 mg/kg. Acute toxicity after inhalation exposure has not been investigated. This endpoint has been waived in accordance with Annex XI section 1.2: no testing for acute toxicity after inhalations exposure has to be performed because there is sufficient evidence from existing studies that the substance is not acutely toxic up to the limit doses (e.g. acute oral toxicity study with LD50 > 2000 mg/kg; OECD 422 study: NOAEL 1000 mg/kg bw).

Justification for classification or non-classification

The submission substance has not to be classified for acute toxic effects according to Regulation (EC) No. 1272/2008 (CLP).