Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1999 - March 1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River (UK) Ltd, Margate, Kent, UK- Age at study initiation: 8-12 weeks- Weight at study initiation: Males: 223-240g, females: 202-211g- Fasting period before study: overnight- Housing: solid-floor polypropylene cages furnished with woodflakes- Diet (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.- Water (e.g. ad libitum): See above- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19-21- Humidity (%): 46-59- Air changes (per hr):15- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
One dose by gavage, using a metal cannula attached to a graduated syringe
Doses:
The toxicity information available suggested that mortality was unlikely at the maximum dose leve. therefore the animals were treated with 2000 mg/kg
No. of animals per sex per dose:
3 females + 3 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations: ½, 1, 2, 4 hours after dosing and then once daily for 14 days.- Frequency of weighing: At day 0 (Day of dosing), on day 7 +14.- Necropsy of survivors performed: Yes- Other examinations performed: clinical signs: Signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and ataxia, developing on the day of dosing and lasting up to one day after dosing.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
Signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, decreased respiratory rate, laboured respiration and ataxia, developing on the day of dosing and lasting up to one day after dosing.
Body weight:
All animals showed expected gain in bodyweight over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.