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other: GLP compliant guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: 2,6-Dimethyl-4-tert.-butylbenzylcyanid

Test animals

Species:
rat
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% CMC solution in doubly distilled water
Details on oral exposure:
- Concentrations used: 3 and 20 g/100 mL
- Administration volume: 10 mL/kg
Doses:
300 and 2000 mg/kg/bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
No abnormalities
Gross pathology:
Organs without particular findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this test, the LD50 was determined to be greater than 2000 mg/kg bw for female rats.
Executive summary:

In GLP compliant study performed according to OECD guideline 423, six female rats per dose were exposed to 300 or 2000 mg/kg bw of the test substance dissolved in 0.5% CMC solution in doubly distilled water. After an observation period of 14 days the surviving animals were necropsied. No mortality occurred. No clinical signs were observed and gross pathology of the organs showed no particular findings.