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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 14 to 28, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(environmental conditions of animal room not reported)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[(2S)-3-methoxy-2-methylpropyl]benzene
Molecular formula:
C11H16O
IUPAC Name:
[(2S)-3-methoxy-2-methylpropyl]benzene
Constituent 2
Chemical structure
Reference substance name:
[(2R)-3-methoxy-2-methylpropyl]benzene
Molecular formula:
C11H16O
IUPAC Name:
[(2R)-3-methoxy-2-methylpropyl]benzene
Test material form:
liquid
Details on test material:
- Physical state: Colourless liquid
Specific details on test material used for the study:
- Storage condition of test material: Stored at room temperature, away from the light and heat (tox specific)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA-CREDO, 69210 L'Arbresle, France
- Age at study initiation: 6 weeks
- Weight at study initiation: Males: 182-203 g; females: 161-188 g.
- Fasting period before study: Animals were fasted overnight prior to test material administration.
- Housing: Animals were housed in groups of 5 by sex in polypropylene cages
- Diet: Complete pelleted rat maintenance diet UAR A04-10 (91360- Epinay sur Orge, France)
- Acclimation period: 5 days

IN-LIFE DATES: From: August 14, 1997 To: August 28, 1997.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 5 mL/kg bw
- Lot/batch no. (if required): Cooper batch F16539

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION (if unusual): Test material was suspended in 0.5 % carboxymethylcellulose (CMC). Preparation was kept up under magnetic stirring during the treatments.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
General appearance, behaviour and vegetative functions of the animals were observed at 1 h after the treatment and during the following 5 h daily for 14 days. Body weights were recorded just prior to the test material administration (on Day 1) and again on Days 4, 8 and 15.
- Necropsy of survivors performed: Yes; animals were sacrificed after barbituric anaesthesia and then autopsied for macroscopic examinations.
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed.
Mortality:
- No mortality was observed.
Clinical signs:
- No clinical signs were observed.
Body weight:
- Body weight gain was normal.
Gross pathology:
- No abnormality was noted at autopsy.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Oral LD50 Combined > 2000 mg/kg bw. Not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the
range of Category 5 values (GHS criteria not met).
Executive summary:

In an acute oral toxicity study (limit test), performed according to OECD Guideline No. 401 and in compliance with GLP, a group of Sprague Dawley OFA rats (5/sex) were administered a single oral dose of test material suspended in 0.5 % carboxymethylcellulose at 2000 mg/kg bw under a constant volume of 5 mL/kg bw by gavage. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality or clinical signs were observed. All animals showed normal body weight gains after the 14 day study period. No abnormalities were noted at autopsy.  

Oral LD50 Combined > 2000 mg/kg bw  

Under the test conditions, the test material is not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw and is not classified according to the GHS since there is no reliable evidence that indicates the LD50 to be in the range of Category 5 values (GHS criteria not met).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.

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