Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not applicable
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name test substance: CdTe supplied by 5N Plus Inc (Montreal, Canada)
Synonyms: Cadmium Telluride
Batch No.: 76337
Appearance: Black, solid (powder > 75 μm)
Production date: March 2008
Receipt Date: 08 April 2008
Expiry Date: 6 months after opening.
Storage Conditions: Keep in a tightly sealed container in a cool, well-ventilated area, away from acid.
Safety Precautions: Routine safety precautions for unknown materials were applied to assure personnel health and safety.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (Europe)Laboratories Inc. (TOXI-COOP KFT, 1103 Budapest, Hungary)
- Weight at study initiation (g): 210-212
- Housing: in groups of 3 in solid-floor cages (Type III) with stainless steel mesh lids and softwood flake bedding.
- Diet: ssniff SM R/M-Z+H “Autoclavable Complete Feed for Rats and Mice – Breeding and Maintenance” (ssniff Spezialdiäten GmbH, D-59494 Soest,
Germany)
- Water: tap water from municipal supplies, as for human consumption, ad libitum.
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12 hours of continuous artificial light in each twenty-four hour period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1% carboxymethylcellulose
Details on oral exposure:
On the day prior to treatment, food was withheld from the animals overnight; water was available to them during this period. On the day of treatment, animals were weighed before dosing. The exact volume to be given was calculated base on each animal‟s body weight and a constant dose volume of 10 ml/kg. The test item formulation was stirred continuously throughout the dosing procedure to ensure each animal was treated with a homogenous solution. A single administration by oral gavage was given to a group of three female rats. Food was made available to the animals 3 hours after the treatment. The treatment was followed by a fourteen-day observation period.
Doses:
2000mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Morbidity/Mortality: Animals were checked daily during the observation period for morbidity and/or mortality.
Clinical Signs: All animals were observed for clinical signs once during the first 30 minutes after treatment, approximately one, two, three, four and six hours after dosing and subsequently once daily for fourteen days. Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Bodyweight: Individual bodyweights were recorded prior to treatment on the day of dosing (Day 0) and on Days 7 and 14.
Necropsy: At the end of the fourteen-day observation period the animals were sacrificed by exsanguination under anaesthesia and gross necropsies performed. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All gross pathological changes were recorded for each animal on the post mortem record sheets.

Statistics:
Data evaluations included the relationship, if any, between the animals‟ treatment with the Test Item and the incidence and severity of all abnormalitiesincluding mortality, behavioural or clinical observations, bodyweight changes, macroscopic abnormalities or any other toxicological effects

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality observed
Clinical signs:
No clinical signs observed
Body weight:
Normal body weight development was noted during the study, with the exception of a single female animal which showed a slight body weight loss during week 2 only
Gross pathology:
Necroscopy:
Occasional occurrences of pale, raised areas were observed in the lungs of two animals at necropsy. Several instances of pin-prick sized haemorrhage in the lungs were also noted but such alterations are frequently recorded at this facility and are considered to be caused by the termination method used. Mild hydrometra was noted in one female, this is a sporadic occurrence in laboratory maintained rat and is without toxicological significance.
Other findings:
none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute oral toxicity (LD50>2000mg/kg)
Executive summary:

The purpose of this study was to assess the acute oral toxicity of CdTe.

No deaths occurred in two groups of three rats treated at a dose level of 2000 mg/kg. The acute oral lethal dose (LD50) of CdTe, in Wistar Crl:(WI) BR strain rats, was therefore considered to be greater than 2000 mg/kg.