Methyl 2-hexyl-3-oxocyclopentanecarboxylate

Endpoint summary

Description of key information

Oral LD50 is >5000 mg/kg bw

Dermal LD50 is >5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

- Description: Clear liquid

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 - 300g
- Fasting period before study: 18 hours
- Housing: 5/cage in wire mesh cages in a temperature controlled room
- Diet: Fresh Purina Rat Chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least one week

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed: mortality and signs of toxicity at 3-4 hours after dosing and daily for 14 days. All rats were examined for gross pathology.

Key result

Sex:

male

Dose descriptor:

discriminating dose

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Lethargy was observed in 2 animals on day 0. Chromorhinorrhea was noted in 1 animal on day 9.

Gross pathology:

One animal had a dark liver and a pale kidney. One animal had red and yellow areas on intestines and a dark kidney.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

One Klimisch 2 study available. Performed similar to guideline.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

One Klimisch 2 study available. Performed similar to guideline.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed similar to OECD 401 (except body weight determination), the test substance was administered via oral gavage to ten male Wistar rats. The concentration administered was 5000 mg/kg bw and the animals were observed for 14 days. No mortality was observed. Lethargy was observed in 2 animals on day 0. Chromorhinorrhea was noted in 1 animal on day 9. One animal had a dark liver and a pale kidney. One animal had red and yellow areas on intestines and a dark kidney. The LD50 was determined to be >5000 mg/kg bw.

Acute dermal toxicity:

In an acute dermal toxicity study performed similar to OECD 402, the test substance was administered dermally under occlusive conditions for 24 hours to ten New Zealand White rabbits. The concentration applied was 5000 mg/kg bw and the animals were observed for 14 days. In half, abrasions were made longitudinally every 2-3 cm over the exposed area. The abrasions were sufficiently deep to penetrate the stratum corneum but not deep enough to produce bleeding. Two animals died. Adverse effect observed among the surviving animals included diarrhea and mucous in the stool. Upon necropsy, dark liver, brown anogenital exudate, bloated intestines was observed in the survived animals. More severe effects were observed in the animals who died. The LD50 was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

The test substance does not have to be classified for acute oral or dermal toxicity according to Regulation (EC) No 1272/2008.