Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Cobs
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
-Weight at study initiation: 146 g for the males and 125 g for the females
-Fasting period before study: prior to gavage, the animals were fasted overnight. Food was given again 4 hours after treatment.
-Housing: the animals were kept: in sterilized polycarbonate cages (5 animals per cage) with a size of 42,0 x 27,0 x 15,0 cm covered with a stainless steel wire mesh lid and containing food and a water bottle. The bedding was sterilized wooden saw dust (Supplier : Société Parisienne des Sciures, 93500 Pantin, France). Wooden saw dust analysis of the contaminants is periodically performed by the Laboratoire Municipal de Rouen (76000 Rouen, France).
-Diet: the animals were fed with a certified pelleted diet (Rat and Mice n° 1, Expanded SOC, Special Diets Services Ltd, Nitham, Essex, England). Food was given ad libitum during all the study
-Water: The animals had free access to tap water filtered with Millipore filters (0,22 micron) in water bottles.
-Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): 21 ± 3 °C
-Humidity (%): 50 ± 20 %
-Air changes (per hr): The animals were maintained in an air conditioned room. The incoming, non-recycled air, was filtered by an absolute filter
-Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle: 20 ml/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed frequently the day of treatment and twice daily during the observation period to note any change in behaviour or health condition.
- Frequency of weighing: Body weights were recorded on D 0, D 4, D 7 and D 14.
- Necropsy of survivors performed: yes
- Other examinations performed: the macroscopic examination of the main organs was performed on all animals killed by C02 asphyxiation at the end of the observation period.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the observation period.
Clinical signs:
A slight hypokinesia was observed after treatment then the general behaviour of the animals was not influenced by the treatment.
Body weight:
The body weight gain of male and female animals was not influenced by the treatment.
Gross pathology:
No macroscopic abnormalities were observed at necropsy. Consequently no sampling of tissues and no histological investigation were performed.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The oral LD50 value of the substance in rats was established to exceed 5000 mg/kg bw.
Executive summary:

An acute oral toxicity study was performed treating five male and five female rats with test substance. The study was conducted according to the recommendation of the OECD Guideline 401 (1981). No death occurred after a single administration of 5000 mg/kg which corresponds to the maximum administrable dose level.

A slight hypokinesia was observed after treatment but the behaviour and body weight gain of the animals were not influenced by the treatment.

The macroscopic investigations revealed no lesion in the animals sacrificed at the end of the observation period.

The oral LD50 value of the substance in rats was established to exceed 5000 mg/kg bw.