(2-methyl-5-propan-2-ylcyclopentyl) propanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 18 May and 02 June 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP study conducted in compliance with OECD Guideline No. 423 without any deviation. The substance is adequately identified, but some data on composition is missing. Therefore validation applies with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

17 December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

Directive n° 2004/73/EC.

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 2009-09-03 / Signed on 2009-12-10

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 1]

Molecular formula:

C12 H22 O2

IUPAC Name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 1]

Constituent 2

Reference substance name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 2]

Molecular formula:

C12 H22 O2

IUPAC Name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 2]

Constituent 3

Reference substance name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 3]

Molecular formula:

C12 H22 O2

IUPAC Name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 3]

Constituent 4

Reference substance name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 4]

Molecular formula:

C12 H22 O2

IUPAC Name:

(2-methyl-5-propan-2-ylcyclopentyl) propanoate [ISOMER 4]

Test material form:

liquid

Details on test material:

- Physical state: colourless translucent liquid
- Storage condition of test material: Room temperature

Specific details on test material used for the study:

- Date received: 10 May 2010

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle – France)
- Age at study initiation: 8 weeks
- Weight at study initiation: 197-212 g
- Fasting period before study: Food was removed at Day 1 and then redistributed 4 h after the test item administration.
- Housing: Animals were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: foodstuff (M20, SDS), ad libitum
- Water: Drinking water (tap-water from public distribution system), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: fifteen changes per hour.
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: from 18 May to 02 June, 2010.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

TEST SUBSTANCE ADMINISTRATION
- Test substance was administered by gavage under a volume of 2.11 mL/kg bw using a suitable syringe graduated fitted with an oesophageal metal canula.

MAXIMUM DOSE VOLUME APPLIED: 2.11 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item. Observations and a mortality report were then carried out every day for 14 days. Animals were weighed on Day 0 (just before administering the test item) then on Days 2, 7 and 14.
- Necropsy of survivors performed: Yes; On Day 14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels, then animals were subjected to macroscopic observations.

Statistics:

None

Results and discussion

Preliminary study:

None

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred during the study.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related tot he administration of the test item were observed.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not revealed treatment related changes

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 for test substance is higher than 2000 mg/kg bw in female rats. The LD50 cut-off of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.Therefore, the substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 female Sprague Dawley rats were given a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed.The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

 

Oral LD50 Female > 2000 mg/kg bw. The LD50 cut-off of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.

Under the test conditions, the substance is not classified according to the annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

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