Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
22 March 1996
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
Official Journal No. L248, 30.9.96
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Hsd:Sprague-Dawley(CD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon
- Females (if applicable) nulliparous and non-pregnant: Not specified
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 93 - 120g
- Fasting period before study: overnight and then 4 hours after dosing
- Housing: metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 40-70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
CLASS METHOD
- Rationale for the selection of the starting dose: starting dose when no information is available to suggest testing at a lower dose.
Doses:
200 and 2000 mg/kg
No. of animals per sex per dose:
200 mg/kg - 3 males, 3 females
2000 mg/kg - 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals checked twice per day; weighed on Day 1 (prior to dosing), Day 8 and Day 15, or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination of cranial, thoracic and abdominal cavities, macroscopic appearance of all examined organs recorded
Statistics:
None.

Results and discussion

Preliminary study:
3 females rates dosed at 2000 mg/kg. 2 died within 4 hours of dosing and other sacrificed after 5 hours due to the severity of the clinical signs.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg: 2 deaths, 1 sacrifice
200 mg/kg: no mortality
Clinical signs:
2000 mg/kg: prior to death - piloerection, hunched posture, underactivity and abnormal gait in all animals
200 mg/kg: no clinical signs observed
Body weight:
All surviving animals had satisfactory weight gains throughout the study
Gross pathology:
2000 mg/kg: congestion of the brain in one animal and the liver of a second animal. A small heart was recorded for one female. Congestion and fluid content were noted in the stomach and along the alimentary tract of all three animals
200 mg/kg: no abnormalities were revealed in macroscopic examination

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Equivalent to Xn, R22 classifiaction under Directive 67/548EEC
Conclusions:
The LD50 value of the test substance was determined to be <2000 mg/kg but >200 mg/kg in this study.