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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Summary report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Please refer to confidential details on test material.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks old
- Weight at study initiation: 191-201 g on day 1

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
300 and 2000 mg/kg bw (10 mL/kg bw)
No. of animals per sex per dose:
3 rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: repeated observation for clinical signs following treatment, then daily; daily weighing
- Necropsy of survivors performed: no data
Statistics:
Not performed

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: There was no mortality.
Mortality:
No deaths occurred.
Clinical signs:
300 mg/kg bw:
No clinical signs were observed.
2000 mg/kg bw:
Hypoactivity and piloerection were noted in all animals from day 1 until day 2 (1 animal) or day 3 (2 animals). Staggering gait (2 animals) and rhinorrea (all animals) were also observed on day 2.
Body weight:
The body weight gain of the animals given 300 or 2000 mg/kg bw was not affected by treatment with the test item.

Applicant's summary and conclusion