Butyl O-butyryllactate

Endpoint summary

Description of key information

Acute oral toxicity: similar to OECD TG 401: LD50 >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

Study period:

Study period not specified

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:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace animals
- Age at study initiation: Approx. 9 weeks
- Weight at study initiation: 169-194 g
- Fasting period before study: 16-20 hours
- Housing: Five per cage in suspended wire cages (20" x 10" x 7")
- Diet: Fresh Purina rat chow, ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

No details

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
- Frequency of observations: 3-4 hours after dosing and once daily for 14 days. Mortality and toxicity were recorded.
- Necropsy of survivors performed: yes, all animals were examined for gross pathology

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed

Clinical signs:

other: All animals were normal 3-4 hours post dose thru Day 5. One instance of alopecia was noted on Day 6. All animals were normal on Days 7 thru 12. One instance of diarrhea was noted on Days 13 and 14.

Gross pathology:

All animals, sacrificed on Day 14, were normal.

Interpretation of results:

other: not acute harmful

Remarks:

according to EU CLP Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

The acute oral toxicity test showed an LD50 of >5000 mg/kg bw.

Executive summary:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD) following GLP, 10 male Wistar rats were administered the test substance orally at a dose level of 5000 mg/kg bw. The animals were observed for mortality and clinical signs for 14 days. Necropsy was performed after 14 days. No mortality was observed during the study and clinical signs were limited to alopecia on day 6 in one animal and diarrhea in one animal on day 13 and 14. All animals were normal at necropsy. The acute oral LD50 for the test substance in rats was determined to be >5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed similar to OECD 401 (pre-OECD) following GLP, 10 rats were administered the test substance orally at a dose level of 5000 mg/kg bw. The animals were observed for mortality and clinical signs for 14 days. Necropsy was performed after 14 days. No mortality was observed during the study and clinical signs were limited to alopecia on day 6 in one animal and diarrhea in one animal on day 13 and 14. All animals were normal at necropsy. The acute oral LD50 for the test substance in rats was determined to be >5000 mg/kg bw.

Acute dermal toxicity:

In the acute oral toxicity study of Moreno, 1980 also a dermal toxicity study was included, which was performed similar to OECD 402. The acute dermal toxicity study was conducted with 10 New Zealand White rabbits receiving a dermal application of 5000 mg/kg bw of the test material. The dermal LD50 exceeded 5000 mg/kg bw.

Justification for classification or non-classification

The substance does not have to be classified for acute oral toxicity in accordance with EU CLP (EC 1272/2008 and its amendments).