Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Oct 2006 - 09 Nov 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No necropsy performed; not conducted in compliance with GLP; only limited information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(adopted 17 Dec 2001)
Deviations:
yes
Remarks:
(no necropsy was performed and no details on test material purity given)
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: yes, 12 h pre-dosing until 3 h post-dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 69
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 and 300 mg/kg bw
No. of animals per sex per dose:
- 2000 mg/kg bw: 3 females
- 300 mg/kg bw: 3 males and 3 females
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1, 7 and 14
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
300 - 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All 3 females treated with 2000 mg/kg bw died on the first day post-dosing.
There was no mortality observed in any of the males or females treated with 300 mg/kg bw throughout the study period.
Clinical signs:
2/3 females dosed with 2000 mg/kg bw showed prostration and ataxia before death.
Animals of the 300 mg/kg bw dose groups did not show any signs of toxicity throughout the study period.
Body weight:
Body weight gain in animals dosed with 300 mg/kg bw was as expected.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
CLP: Acute Oral 4, H302