Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29th September 2004 to 19th October 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The test item was evaluated in rats according to OECD (No. 423, 17th December 2001) and EC (2004/73/EEC, B.1 tris, 29th April 2004) guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2005

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 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Beige powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Number and sex: two groups of three females were used.
Age/weight: on the day of treatment, the animals were approximately 8 weeks old, and had a mean body weight ± standard deviation of 197 ± 13 g.
Acclimation: at least 5 days before the beginning of the study.
Allocation to study: before the beginning of the study, on day 1, the required number of animals was selected according to body weight and clinical condition.
Identification: individually by earnotches.

The conditions in the animal room were set as follows:
• temperature: 22 ± 2°C
• relative humidity: 30 to 70%
• light/dark cycle: 12 h/12 h
• ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The temperature and relative humidity were under continuous control and recording. The records were checked daily and filed. In addition to these
daily checks, the housing conditions and corresponding instrumentation and equipment are verified and calibrated at regular
intervals.
The animals were housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals during
the acclimation period and three rats of the same group during the treatment period.
Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
Sawdust is analyzed by the supplier for composition and contaminant levels.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methylcellulose
Control animals:
no
Details on study design:
The test item was prepared in 0.5% methylcellulose and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of fasted female Sprague-Dawley rats.
The study design was as follows (as no deaths occurred in the first treated group, the results
were then confirmed in another group of three females):
Dose (mg/kg) Volume (mL/kg) Female
2000 10 3
2000 10 3
Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item.
All animals were subjected to necropsy.
The interpretation of results was carried out according to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent
adaptations).

Results and discussion

Preliminary study:
Dose-level of 2000 mg/kg (three females then confirmation on three other females)
No deaths occurred during the study.
Hypoactivity was observed in 3/6 females, within 2 hours of treatment.
No other clinical signs were noted during the study.
The overall body weight gain of the animals was not affected by treatment with the test item.
At necropsy, no apparent abnormalities were observed in any animal.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred during the study.
Clinical signs:
Hypoactivity was observed in 3/6 females, within 2 hours of treatment.
No other clinical signs were noted during the study.
Body weight:
The overall body weight gain of the animals was not affected by treatment with the test item.
Gross pathology:
At necropsy, no apparent abnormalities were observed in any animal.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions, the oral LD50 of the test item is higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by
oral route, the test item should not be classified.
Executive summary:

Under the experimental conditions, the oral LD50 of the test item is higher than 2000 mg/kg in rats. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, the test item should not be classified.