Fatty acids lanolin, di-, tri- and tetraesters with pentaerythritol and rape fatty acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study similar to guideline with acceptable restrictions (limited information on test substance, applied volume (1.5 mL/100 g bw) exceeds the recommended value).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Adopted 24 February 1987

Deviations:

yes

Remarks:

limited information on test substance, applied volume (1.5 mL/100 g bw) exceeds the recommended value

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)

EC Number:

263-423-1

EC Name:

2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)

Cas Number:

62125-22-8

IUPAC Name:

62125-22-8

Test animals

Species:

rat

Strain:

other: CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent
- Weight at study initiation: males: 247.2 g ± 3.4 g, females: 201.2 g ± 9.0 g
- Fasting period before study: overnight before dosing
- Housing: in single sex groups in polypropylene cages
- Diet: smodified 41B diet, Pilsbury´s Limited, Birmingham, UK, ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
controlled temperature and lighting conditions

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

vegetable oil

Details on oral exposure:

VEHICLE
- Amount of vehicle: 15 mL/kg bw
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 15 mL/kg bw

Doses:

10.000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were examined immediately and 4 h after dosing and then daily.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: All the rats were hypoactive at the 4 h observation period. No further signs of toxicity were noted during the study period.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.