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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
Exposure period of 14 days.
Doses:
2000 mg/kg bodyweight.
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Preliminary study:
A range-finding study was conducted using 1 female and 1 male rat to establish the dosing regime. The dose level was 2000 mg/kg, the concentration was 200 mg/ml and the dose volume was 10 ml/kg. Overt signs of toxicity or death were observed 30 minutes, 1, 2 and 4 hours after dosing, and then once daily for 5 days. The range-finding test found no deaths or clinical signs of toxicity. As a result, a dose of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Two females died one or two days after dosing.
Clinical signs:
Common signs of systemic toxicity noted were ataxia, hunched posture, lethargy, decreased respiratory rate and laboured respiration with isolated incidents of hypothermia and loss of fighting reflex.
Body weight:
Surviving animals showed expected bodyweight gain during the study.
Gross pathology:
Abnormalities noted for the two females that died were haemorrhagic lungs, dark liver, dark kidneys, slight haemorrhage of the gastric mucosa and/or haemorrhage of the small and large intestines. No abnormalities were noted of the animals that were killed at the end of the study.

Any other information on results incl. tables

See the attached background material for tables providing information on individual clinical observations and mortality data in the range finding study, individual clinical observations and mortality data in the main study, individual bodyweights and weekly bodyweight gain in the main study, and individual necropsy findings in the main study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain of rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The oral acute toxicity of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 401. Male and female rats were exposed to 2,000 mg/kg bw of the test substance. The LD50 was found to be > 2,000 mg/kg bw.