Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-09-03 - 2003-11-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 423) performed under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted on 22nd March 1996
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Test material form:
solid: bulk
Details on test material:
Please refer to "Confidential details on test material".

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old
- Body weight at study initiation: 306 ± 25 g (males), 220 ± 3 g (females)
- Housing: 3 animals/sex/cage 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
- Diet: A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France), ad libitum, except for an overnight fasting period prior to testing (free access to water)
- Water: Drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 30 - 70%
- Air changes: approximately 12 air changes/hour
- Photoperiod: 12 h / 12 h

IN-LIFE DATES: From: 2003-09-11 To: 2003-10-02

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methylcellulose
Details on oral exposure:
VEHICLE:
- Concentration in vehicle: 20 or 200 mg/mL, based on dose volume
- Amount of vehicle/dose volume: 10 mL/kg bw
- Justification for choice of vehicle: to make dosing by gavage possible
- Purity: no data

DOSAGE PREPARATION:
- The test item was prepared in a 0.5% suspension of methylcellulose in purified water.

CLASS METHOD:
- Rationale for the selection of the starting dose: As no information on the toxic potential of the test item was available, for animal welfare
reasons, the starting dose of 200 mg/kg bw was chosen.
Doses:
200 and 2000 mg/kg bw (tested concentrations)
No. of animals per sex per dose:
3 males (200 mg/kg)
3 males/ 3 females (2000 mg/kg)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Mortality/Viability and frequency of observations (clinical signs): The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day. Type, time of onset and duration of clinical signs were recorded for each animal individually.

- Frequency of weighing: The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight.

- Necropsy of survivors performed: yes, on day 15, all animals were killed by carbon dioxide asphyxiation and examined macroscopically. All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. No organ samples were taken.
Statistics:
No statistical testing was performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at any dose level tested.
Clinical signs:
other: No clinical signs were observed in the animals given 200 mg/kg bw. At the 2000 mg/kg bw dose-level, piloerection and dyspnea, together with hypoactivity in females, were observed in all animals on day 1.
Gross pathology:
Macroscopic examination revealed no apparent abnormalities.

Applicant's summary and conclusion