Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult animals (approx. 8 weeks old)
- Weight at study initiation: males mean of 288 g, females mean of 165-183 g
- Fasting period before study: overnight (for a maximum of 20 h)
- Housing:3 animals per sex/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.12.2002 To: 07.01.2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg b.w.
Doses:
2000 mg/kg (10mL/kg) b.w.
200 mg/kg (10mL/kg) b.w.
No. of animals per sex per dose:
3 females 2000 mg/kg b.w.
3 females 200 mg/kg b.w.
3 males 200 mg/kg b.w.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: at 0, 2 and 4 h after dosing and once daily thereafter
- Frequency of weighing: day 1, day 8 and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs were subjected to necropsy and descriptions of all internal macroscopic
abnormalities recorded

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 200 - ca. 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals at 2000 mg/kg b.w. were found dead. The decedents were found dead within 2 hour post treatment. No further mortality occurred at 200 mg/kg b.w..
Clinical signs:
2000 mg/kg b.w.: lethargy, flat and hunched posture, salivation, moribund, slow breathing, piloerection,
200 mg/kg b.w.: restless, hunched posture, chromodacryorrhoea, lethargy
The surviving animals had recovered from the symptoms between days 2 and 3.
Body weight:
The body weight gain shown by the animals over the study period was considered to be normal.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
At 2000 mg/kg b.w. all animals died within 2 hours after dosing. At 200 mg/kg b.w. no mortality occurred and therefore the LD50 was considered to be in the range of 300 - 2000 mg/kg b.w..
Executive summary:

At 2000 mg/kg b.w. all animals died within 2 hours after dosing. At 200 mg/kg b.w. no mortality occurred and therefore the LD50 was considered to be in the range of 300 - 2000 mg/kg b.w.. Also at 200 mg/kg b.w. clinical signs such as restlessness, hunched posture, chromodacryorrhoea and lethargy were noted.