Lanolin, acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 March 1974 to 15 March 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Study purpose was to determine the acute oral toxicity in rats.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Lanolin, acetate

EC Number:

262-979-2

EC Name:

Lanolin, acetate

Cas Number:

61788-48-5

Molecular formula:

Variable

IUPAC Name:

Lanolin, Acetates

Test material form:

solid

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 24 hours
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: 1 week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10.0 mL/kg

DOSAGE PREPARATION: warmed to body temperature

Doses:

2.5, 5.0, 10.0, 20.0, 40.0 mL/kg

No. of animals per sex per dose:

2/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No

Statistics:

No information available.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Mortality:

No mortalities

Clinical signs:

other: Not examined/ determined.

Gross pathology:

Not examined/ determined.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, the LD50 of the test material was determined to be >10.0 mL/kg in rats.

Executive summary:

The test substance was administered by tube directly into the stomachs of Sherman-Wistar rats (2 animals per sex per dose), was not lethal at doses of 40.0 mL/kg and lower. Since 8 out of 8 rats receiving doses of between 5.0 and 40.0 mL/kg survived, it was concluded LD₅₀ >10.0 mL/kg.