Acetic acid, esters with lanolin alcs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2nd February 1973 - 27 February 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

pre-dates 2002

Deviations:

not applicable

GLP compliance:

no

Remarks:

pre-dates GLP

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyl acetate

EC Number:

211-103-7

EC Name:

Hexadecyl acetate

Cas Number:

629-70-9

Molecular formula:

C18H36O2

IUPAC Name:

hexadecyl acetate

Constituent 2

Reference substance name:

Acetic acid, esters with lanolin alcs.

EC Number:

262-980-8

EC Name:

Acetic acid, esters with lanolin alcs.

Cas Number:

61788-49-6

Molecular formula:

C29H48O2

IUPAC Name:

Acetic acid, esters with lanolin alcs.

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sherman

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 24 hours
- Acclimation period: 1 week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2.5, 5.0, 10.0, 20 and 40 mL/kg
Equivalent to 200-450, 400-900, 800-1800, 1600-3600 and 3200-7200 mg/kg of the registered substance.

No. of animals per sex per dose:

1 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days)
- Frequency of observations: Daily
- Necropsy of survivors performed: no

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 200 mg/kg bw

Based on:

act. ingr.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 40 mL/kg bw

Based on:

test mat.

Mortality:

No mortality observed during the study

Any other information on results incl. tables

Table 1: Mortality (14 day observation period)

Dose (mL/kg) (mg/kg dose range)	No. of rats dosed	Mortality Day 1	Mortality Day 2	Mortality Day 3	Mortality Day 4	Mortality Day 5	Mortality Day 6	Mortality Day 7	Mortality Day 8	Mortality Day 9	Mortality Day 10	Mortality Day 11	Mortality Day 12	Mortality Day 13	Mortality Day 14	Mortality after 14 days
2.5 mL/kg (200-400 mg/kg)	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
5.0 mL/kg (400-900 mg/kg)	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
10 mL/kg (800-1800 mg/kg)	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
20 mL/kg 1600-3600 mg/kg)	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2
40 mL/kg (3200-7200 mg/kg)	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/2

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test material in albino rats was determined to be greater than 40 mL/kg of the test material. This is equivalent to an LD50 of the registered material of greater than 3200 mg/kg.

Executive summary:

The acute oral toxicity of the test material was evaluated in a study conducted in albino rats. The test material was administered to one male and one female in each of the dosing groups via stomach tube at the following doses 2.5, 5.0, 10.0, 20 and 40 mL/kg. This was equivalent to 200-450, 400-900, 800-1800, 1600-3600 and 3200-7200 mg/kg of the registered substance. The animals were observed for 14 days for signs of acute toxicity. No mortality was observed during the study. The LD50 of the test material in albino rats was determined to be greater than 40 mL/kg of the test material. This is equivalent to an LD50 of the registered material of greater than 3200 mg/kg.