Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry, permission to refer granted by ECHA

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Methocel 0.5%

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
The main clinical signs observed were: hypoactivity,
muscular tremors, salivation, palpebral closure,
hypothermia, shallow breathing, piloerection and hunched
posture starting from 30 minutes - 4 hours and lasting up to
6-24 hours after the test article administration.
Sporadic cases of ataxia, reddish nasal discharge,
chromodacryorrhea were also observed.
Recovery of all treated rats was achieved within 24
(females) - 48 hours (males) of treatment.
Low body weight gain was observed in some animals only at
the day 3 weighing. Body weight gain returned to normal at
the subsequent weighing.
Gross pathology:
Effects on organs:
Terminal autopsy findings were normal.

Applicant's summary and conclusion

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