[No public or meaningful name is available]

Endpoint summary

Description of key information

A single oral dose of 2 g/kg (2000 mg/kg), formulated in corn oil, was administered to a group of five male and five female Sprague-Dawley (SD) rats. All animals of each sex survived until the time of terminal sacrifice on Day 15. No clinical signs of toxicity were noted in any animal and no abnormal findings were noted at necropsy. Based on the results of this study, the test material is not toxic to male and female Sprague-Dawley (SD) rats.

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:

17 March 1995 to 07 June 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

Description: reddish-brown liquid

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Test animals approximately 5 weeks of age; 6 weeks old at study start
- Animals were quarantined 9 days prior to test article administration
- Housing: polycarbonate cages
- Diet: Purina Certified Rodent Chow No. 5002
- Water: Tap water, analyzed at least annually

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Single dose

Doses:

2 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

All animals observed twice on Test Day 1 approximately 1 and 3 hours following test article administration, and once daily thereafter until necropsy on Day 15.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No adverse signs

Gross pathology:

No gross lesions observed

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the tes material is not toxic to male and female Sprague-Dawley (SD) rats when administered as a single oral dose of 2000 mg/kg

Executive summary:

A single oral dose of 2 g/kg (2000 mg/kg), formulated in corn oil, was administered to a group of five male and five female Sprague-Dawley (SD) rats. All animals of each sex survived until the time of terminal sacrifice on Day 15. No clinical signs of toxicity were noted in any animal and no abnormal findings were noted at necropsy. Based on the results of this study, the test material is not toxic to male and female Sprague-Dawley (SD) rats.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw