2,2,5-trimethyl-5-pentylcyclopentan-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401 with a deviation: 2 animals/sex/dose were used instead of 5 animals of the same sex/dose. This deviation is not considered to have affected the reliability of the study.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

2 animals/sex/dose were used, no details test animals, environmental condition of animal room

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Remarks:

(pre-GLP)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

EC Number:

265-779-3

EC Name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

Cas Number:

65443-14-3

Molecular formula:

C13H24O

IUPAC Name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 0977/1 100%
- Physical state: Clear, colourless liquid

Test animals

Species:

rat

Strain:

other: Charles River CD® Strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts, USA.
- Weight at study initiation: Males: 152-226 g; females: 146-162 g
- Fasting period before study: Animals were fasted for 24 h before dosing.
- Housing: Animals were housed in suspended, wire-mesh stock cages.
- Diet: Purina® Rat Chow® 5012 (Ralston Purina Company, St. Louis, Missouri, USA), ad libitum
- Water: Water, ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

900, 3038 and 6834 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Animals were observed for mortality and clinical signs daily for 14 days. Initial and final bodyweights of animals were recorded.
- Necropsy of survivors performed: Yes; animals were subjected to gross necropsy.

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 6 834 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

- No mortality was observed.

Clinical signs:

other: - No clinical signs were observed in animals treated with 900 mg/kg bw dose. - Hypoactivity was observed in animals within 15 minutes of dosing at 3038 mg/kg bw, and all animals were recovered after 6-22 h. - Hypoactivity, muscular weakness, laboured brea

Gross pathology:

- Enlarged uterine horns was observed in one female at 3038 mg/kg bw.
- No abnormalities were noted at necropsy in other animals.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Oral LD50 Combined > 6834 mg/kg bw

Executive summary:

In an acute oral toxicity study, 3 groups of Charles River CD® Strain rats (2/sex/dose) were administered a single oral dose of test material at 900, 3038 and 6834 mg/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 was observed. Hypoactivity was observed in animals within 15 minutes of dosing at 3038 mg/kg bw, and all animals were recovered after 6-22 h. Hypoactivity, muscular weakness, laboured breathing, lacrimation, diuresis and prostration were observed at 6834 mg/kg bw and animals recovered from clinical signs within 5 days after dosing. All animals showed expected gains in bodyweight over the 14-day study period. No abnormalities were noted at necropsy except enlarged uterine horn in one female at 3038 mg/kg bw dose.

Oral LD50 Combined > 6834 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).

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