Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 4th June 1997 to 20th June 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CHARLES RIVER
- Age at study initiation: 4 weeks
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 108 - 130 g
- Fasting period before study: Food was removed approximately t8 hours prior to treatment.
- Housing: 5 housed in Malcrolon cages (55 x 32.7 x 19 cm) with sawdust bedding
- Diet: free access to a standard rat diet UAR A04C
- Water: ad libitum, in bottles.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 23 °C
- Humidity: 56 - 86 %
- Photoperiod: 12 hours cycle dark/light (7:00 to 19:00)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Volume: 10 ml/kg
Doses:
2000 mg/kg b.w
No. of animals per sex per dose:
Main test: 5 per sex per dose
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice a day
- Necropsy of survivors performed: yes
- Other examinations performed:
The necropsy included a revision ofthe intact animal and all its superficial tissues, followed by an observation of the cranial, thoracic and abdominal cavities both in situ and after evisceration.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the 14 day observation period.
Clinical signs:
The only observations made on the day of treatment were diarrhoea and the excretion of black-coloured faeces by all the animals on the following two days post-treatment
During the remaining days ofthe Study, no alterations were observed in any of the animals treated at 2000 mg/kg.
Body weight:
All the animals of the dose group of 2000 mg/kg presented a normal evolution of growth.
Gross pathology:
In the necropsies carried out, the animals ofthe 2000 mg/kg dose did not show any visible macroscopic lesions.

Any other information on results incl. tables

PRELIMINARY STUDY

No mortality was recorded in the animal of the preliminary study, one female treated at 2000 mg/kg.

This female, treated at 2000 mg/kg, presented black-coloured faeces in the course of the following two days post-treatment.

No clinical signs were observed for the remaining days ofthe treatment. The female showed a normal evolution of growth.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) no 1272/2008
Conclusions:
The LD50 of test item in rats was found to be greater than 2000 mg/kg bw.
Executive summary:

The acute toxicity of the substance was assessed following oral administration, in Sprague Dawley rats, by the fixed dose method according to the OECD Guideline No.420 (1992) and the Method B.1 bis of the Directive of the Commission of European Communities 92/69/EEC. The substance was administered at the dose of 2000 mg/kg.

None of the animals treated at the dose of 2000 mg/kg died in the course of the Study. The only observations made on the day of treatment and the following day were diarrhoea and the excretion of black-coloured faeces by all the animals. The evolution in bodyweight of all the animals was normal. In the necropsies. there were no macroscopic alterations detected.

The LD50 (oral, rat) was found to be greater than 2000 mg/kg bw.