Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted in 1973.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Very brief results table from an older study conducted prior to development of GLP and current guidlines, information on methodology is minimal

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was conducted prior to development of current guidelines but is broadly comparable to OECD 401. An acute oral study (limit test) was conducted in 10 rats.
GLP compliance:
no
Remarks:
Conducted prior to development of GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Identification: Isobutyl phenyl acetate
Commercial name: 2-methylpropyl phenylacetate
Chemical name: 2-methylpropyl phenylacetate
Empirical formula: C12H16O2
Molecular weight: 192.26 g/mol
EC No.: 203-007-9
CAS No.: 102-13-6
Appearance/physical state: Clear colorless liquid
Batch: SC00010162
Purity: 100%
Expiry date: 31 December 2015
Storage conditions: Room temperature in the dark

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No information available

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
10 rats were administed the test substance by oral gavage
Doses:
5 g/kg (equivalent to approximately 5000 mg/kg)
No. of animals per sex per dose:
10 rats were used, sex was not specified
Control animals:
no
Details on study design:
Rats were observed for signs of toxicity and mortality for 14 days after administration
Statistics:
Not required.

Results and discussion

Preliminary study:
A preliminary study was not conducted
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality at the limit dose
Mortality:
No mortalities
Clinical signs:
No clinical signs were observed
Body weight:
No information given
Gross pathology:
No information given
Other findings:
No other findings reported.

Any other information on results incl. tables

No further information available.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of isobutyl phenylacetate in rats was found to be greater than 5000 mg/kg bw.
Executive summary:

The acute oral toxicity of isobutyl phenylacetate was evaluated in 10 rats. The study was conducted prior to the development of GLP/guidelines. The test substance was administered orally at the limit dose of 5000 mg/kg bw. The rats were observed for clinical signs of toxicity and mortality for 14 days after administration. There were no mortalities, and no signs of toxicity were observed. The acute oral LD50 of isobutyl phenylacetate in rats was found to be greater than 5000 mg/kg bw.