Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: extracted from ECHA database
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 1% (w/v) aqueous methyl cellulose
Doses:
200, 431, 928, 2000 mg/kg

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
929 mg/kg bw
95% CL:
719 - 1 199
Mortality:
0/5 Male/female deaths at 200 mg/kg bw
0/5 Male/female deaths at 431 mg/kg bw
2/5 male and 3/5 female deaths at 928 mg/kg bw
5/5 Male/female deaths at 2000 mg/kg bw
Clinical signs:
Clinical signs were seen in all dose groups within 1 hr of dosing and consisted of hunched posture, pilo-erection, body tremors, excessive salivation, decreased reapiration and (at 431 mg/kg and above) lethargy. Animals receiving 200 mg/kg had recovered by 4 hr after dosing, as had females receiving 431 mg/kg. Males receiving 431 mg/kg and all surviving animals receiving 928 mg/kg continued to show hunched posture and pilo-erection on day 1 (24-48 hr) after dosing but were normal bu day 2.
Isolated animals receiving 2000 mg/kg showed clonic and tonic convultions in addition to the clinical symptoms described above and all animals had died by day 2. All surviving animals showed normal bodyweight gain throughout the study period.
Gross pathology:
Surviving animals showed no abnormality at necropsy with the exception of haemorrhage of the glandular stomach in 1 female receiving 200 mg/kg and the finding of serveral white raised areas in the glandular stomach of one male receiving 431 mg/kg. Decedents showed dark or dark red lungs and livers, pallor of the spleen and haemorrhaging or congestion of the small intestine was also noted. One male and one female receiving 928 mg/kg were not necropsied due to cannibalism.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Although there was a slight difference in the LD50 for females (860 mg/kg) and male (between 928 and 2000 mg/kg estimated), this is of little toxicological significance, and doed not affect the classification of the substance, which on the results of this study must be classified as harmful .