Ethyl salicylate

Endpoint summary

Description of key information

For this enpoint, one key study is available for acute oral toxicity. No data are available on acute toxicity via inhalation or dermal application.

The study has been performed in rats. It did not follow a guideline and was pre-GLP.

Each group of 10 rats were fed orally 0.34, 0.67, 1.31, 2.56 or 5.0 g/kg of test substance as a single dose. The animals were observed for 14 days.

As a result, the test substance can be referred to as a category 4 compound with an LD50 of 1320 mg/kg bw.

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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Toxic properties after a single oral dose of the test substance were investigated by observation for a period of 14 days.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

0.34, 0.67, 1.31, 2.56 and 5.0 g/kg

No. of animals per sex per dose:

10 animals per dose group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 320 mg/kg bw

Based on:

test mat.

95% CL:

>= 1.01 - <= 1.63

Mortality:

0/10 at dose level 340 mg/kg bw
0/10 at dose level 670 mg/kg bw
5/10 at dose level 1310 mg/kg bw
10/10 at dose level 2560 mg/kg bw
10/10 at dose level 5000 mg/kg bw

Clinical signs:

other: - 0.34 - 2.56 g/kg: none; - tremors, labored breathing,flaccid at 5 g/kg

Gross pathology:

not specified

Other findings:

not specified

Distribution of mortality

		Observation Day
Dose (g/kg)	Deaths/No. of Animals	1	2	3	4	5	6	7	8	9	10	11	12	13	14
0.34	0/10
0.67	0/10
1.31	5/10	3	2
2.56	10/10	10
5	10/10	10

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The test substance has an LD50 of 1320 mg/kg bw given as a single dose.

Executive summary:

The study has been performed in order to investigate the toxic propreties of the test substance. Each group of 10 rats were fed orally 0.34, 0.67, 1.31, 2.56 or 5.0 g/kg of test substance as a single dose. The animals were observed for 14 days.

As a result, the test substance can be referred to as a category 4 compound with an LD50 of 1320 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 320 mg/kg bw

Quality of whole database:

The key study is acceptable with restrictions (documentation not complete, no guideline followed, not GLP)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

For this enpoint, one key study is available for acute oral toxicity. No data are available on acute toxicity via inhalation or dermal application.

The study has been performed in rats. It did not follow a guideline and was pre-GLP.

Each group of 10 rats were fed orally 0.34, 0.67, 1.31, 2.56 or 5.0 g/kg of test substance as a single dose.

The animals were observed for 14 days.

As a result, the test substance can be referred to as a category 4 compound with an LD50 of 1320 mg/kg bw.

Justification for classification or non-classification

Acute oral toxicity

The acute oral toxicity study on rats can be used for classification. According to the CLP legislation a substance is considered acute toxic when the acute toxicity estimates (ATE) for the oral route are =< 2000 mg/kg bodyweight. As the LD50 of the test item is 1320 mg/kg bw, the test substance can be referred to as a category 4 compound.