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Toxicological information

Acute Toxicity: oral

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyl salicylate
EC Number:
201-729-9
EC Name:
Isobutyl salicylate
Cas Number:
87-19-4
Molecular formula:
C11H14O3
IUPAC Name:
Isobutyl salicylate

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

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

Results and discussion

Effect levels
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:
No clinical signs were observed
Body weight:
not specified
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

Applicant's summary and conclusion

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.