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Description of key information

Acute toxicity of the test substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
Although no guideline is mentioned in the publication the method follows the classical LD50 test.
GLP compliance:
no
Test type:
other: Although no guideline is mentioned in the publication the method follows the classical LD50 test
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Aldrich Chemiclas, Milwaukee, Wis.
- Purity: 96%
- Impurity: 3% chlorodibromomethane, 1% not stated.
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Biobreeding Labs., Ottawa, Ontario.
- Females (if applicable) nulliparous and non-pregnant: Not stated.
- Age at study initiation: Not stated
- Weight at study initiation: 150-200g (start of acclimation)
- Fasting period before study: Fasted overnight before dosing
- Housing: Not stated.
- Diet (e.g. ad libitum): Not stated.
- Water (e.g. ad libitum): Not stated.
- Acclimation period: One week.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 40 - 60%
- Air changes (per hr): Not stated.
- Photoperiod (hrs dark / hrs light): Not stated.
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not specified
- Amount of vehicle (if gavage): 2 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 2 ml/kg

Doses:
Range-finding:

To establish the dose levels to be used in the LD5O studies, groups of two animals were administered test compounds at 250-3000 mg/kg and the mortality data were recorded.

Main study doses:

546 mg/kg
765 mg/kg
1071 mg/kg
1500 mg/kg
2100 mg/kg
No. of animals per sex per dose:
10 males and 10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Median lethal dose (LD50) was calculated using the probit analysis.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1 388 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 167 - <= 1 693
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
1 147 mg/kg bw
Based on:
test mat.
95% CL:
>= 890 - <= 1 524
Mortality:
Number of dead animals per group:

546 mg/kg = 1/20
765 mg/kg = 5/20
1071 mg/kg = 5/20
1500 mg/kg = 9/20
2100 mg/kg = 20/20
Clinical signs:
Hypothermia was observed, but dose levels not stated.
Body weight:
Not reported.
Gross pathology:
Livers and kidneys were reported to be congested and enlarged at necropsy, but no dose response information was reported.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The acute oral LD50 of the test substance in Sprague-Dawley rats was 1388 and 1147 mg/kg bw in males and females respectively.
Executive summary:

Introduction

The acute oral toxicity of the test substance to Sprague-Daawley rats. No guideline was followed but the study used a method similar to the classical LD50 test.

Method

To establish the dose levels to be used groups of two animals were administered test compounds at 250-3000 mg/kg and the mortality data were recorded and used ot det dosew in the main test. For the main test five doses between 546 and 2100 mg/kg were employed and 10 males and 10 females used at each dose level. Dosing solutions were administered to animals in corn oil using premature infant feeding tubes (8 Fr., 15 in. length) at a maximum volume of 2ml/kg. Clinical observations were made for 14 days after dosing and a post-mortem examination was performed on animals which died during this period. All surviving animals were killed at the end of 14 days and subjected to gross pathologic examination.

Results and Conclusion

The acute oral LD50 of the test substance in Sprague-Dawley rats was 1388 and 1147 mg/kg bw in males and females respectively.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 147 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification