Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier on analogue substance

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989

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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male, 2000 mg/kg bw, number of animals: 5, numebr of death: 0
Male, 5000 mg/kg bw, number of animals: 5, number of death:0
Female, 2000 mg/kg bw, number of animals: 5, number of death:0
Female, 5000 mg/kg bw, number of animals: 5, number of death:0
Clinical signs:
2000 mg/kg : sedation, dispnea, piloerection, hunched posture
5000 mg/kg : sedation, dispnea, piloerection, hunched posture, movement disorder, diarrhoea

the surviving rats recovered within 4 to 6 observation days
Gross pathology:
No pathological changes were revealed for the animals sacrificed at the end of the test
Lung: several dark-red foci, in part, black
Liver, stomach, intestine, kidneys, adrenalas, spleen: black

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU