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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
1-butanol is the main hydrolysis prodcuts of the target substance. Properties of the the hydrolysis substance are used for read-across.

Data source

Reference
Reference Type:
publication
Title:
Food Flavourings and Compounds of Related Structure; I. Acute Oral Toxicity
Author:
Jenner PM, Hagan EC, Taylor JM, Cook EL and Fitzhugh OG
Year:
1964
Bibliographic source:
Fd. Cosmet. Toxicol. 2: 327-343

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: other
Principles of method if other than guideline:
Groups of 10 young adult Osborne-Mendel rats evenly divided by sex were fasted for approximately 18 hours prior to treatment with different doses of the test substance. Doses are not reported, no data on preparation of dosing solutions, no data on body weight gains etc., no data on necropsies.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 510 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 220 - <= 2 840
Mortality:
Mortality occured 4-18 hours after dosing, no further data
Clinical signs:
depression, coma
Body weight:
not reported
Gross pathology:
not reported

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The oral LD50 on rats was 2510 mg/kg bw. Meet acute oral toxicity category 5 according to GHS.
Executive summary:

As the target substance hydrolyses rapidly (half-life < 5 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.