Isobutyl salicylate

Endpoint summary

Description of key information

The LD50 of the test item is 1310 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:

1973

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:

In total, 50 rats (10 rats/dose) were treated by oral route with a single dose of the test item at dose 830 mg/kg, 1040 mg/kg, 1310 mg/kg, 2050 mg/kg and 5000 mg/kg.
Following dosing, the animals were observed during 14 days.

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

830 mg/ kg bw, 1040 mg/kg bw, 1310 mg/kg bw, 2050 mg/kg bw, 5000 mg/kg bw

No. of animals per sex per dose:

10 animals

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 14 days

Sex:

not specified

Dose descriptor:

LD50

Effect level:

1 310 mg/kg bw

Based on:

test mat.

Mortality:

3/10 at dose level 1040 mg/kg bw
5/10 at dose level 1310 mg/kg bw
8/10 at dose level 2050 mg/kg bw
9/10 at dose level 5000 mg/kg bw

Clinical signs:

other: No clinical signs were observed

Gross pathology:

Skin irritation was observed: slight redness in 4/8 animals, moderate redness in 2/8 animals, and slight edema in 2/8 animals

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The test item had an LD50 of 1310 mg/kg in the current study.

Executive summary:

In the current study the acute oral toxicity of the test item was assessed. The methodology of the study was not described, therefore, it is assumed it was not according to OECD guideline. It was not indicated that the study was according to GLP.

In total 50 rats (10 rats/dose) were treated by oral route with a single dose of the test item at dose 830 mg/kg, 1040 mg/kg, 1310 mg/kg, 2050 mg/kg and 5000 mg/kg.

Following dosing, the animals were observed for 14 days.

At dose level 1040 mg/kg bw, 3/10 animals died on Day 2 after dosing. At dose level 1310 mg/kg, 5/10 animals died (3 on Day 1 after dosing and 2 on Day 2 after dosing). At dose level 2050 mg/kg, 8/10 animals died (1 on Day 1 after dosing and 7 on Day 2 after dosing). At dose level 5000 mg/kg, 9/10 animals died (3 on Day 1 after dosing, 5 on Day 2 after dosing and 1 on Day 3 after dosing).

No clinical signs were observed. Body weight was not specified in the study report. Skin irritation occurred: slight redness in 4/8 animals, moderate redness in 2/8 animals, and slight edema in 2/8 animals.

As the test item induced the death of the half of the animals at dose level 1310 mg/kg, the test item should be classified according to 1272/2008 CLP regulation as Acute Oral toxicity Category 4.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 310 mg/kg bw

Quality of whole database:

The conclusion of the adverse effect of the test item is based on 1 study on the test item with a K2.

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

The first study was performed on the test item in order to assess the acute oral toxicity.

The methodology of the study was not described, therefore, it is assumed it was not according to OECD guideline. it was not indicated that study was according to GLP as well.

In total 50 rats (10 rats/dose) were treated by oral route with a single dose of the test item at dose 830 mg/kg, 1040 mg/kg, 1310 mg/kg and 5000 mg/kg.

Following the dosing, the animals were observed during 14 days.

At the level 1040 mg/kg, 3/10 animals died on Day 2 after dosing. At dose level 1310 mg/kg bw 5/10 animals died (3 on Day 1 and 2 on Day 2 after dosing). At dose level 2050 mg/kg 8/10 animals died (1 on Day 1 and 7 on Day 2 after dosing). At dose level 5000 mg/kg, 9/10 animals died (3 on Day 1, 5 on Day 2 and 1 on Day 3 after dosing). The LD50 was 1310 mg/kg bw.

Justification for classification or non-classification

Based on the available, an LD50 at 1310 mg/kg bw was set.

According to the hazard category indicated in the table 3.1.1 of the CLP Regulation 1272/2008 the substance has to be classified as Acute Oral Toxicity Category 4.