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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Description of key information

Acute Toxicity: oral

The acute oral LD50 for male abino rats was found to be 6.81 ml/kg of body weight. The acute toxicity was evaluated using the procedures outlined in the Regulations under the Federal Hazardous Substances Labeling Act.

Acute Toxicity: dermal

The acute dermal LD50 for albino rabbits was found to be in the range of 10.0 ml/kg of body weight. The acute toxicity was evaluated using the procedures oulined in the Regulations under the Federal Hazardous Substances Labeling Act.

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
Study period:
28 September 1965 to 16 December 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: Regulations (Federal Register, August 12, 1961 et seq) under the Federal Hazardous Substances Labeling Act
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Holtzman
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 270-281 grams
- Fasting period before study: Yes. 18 hours before prior to dosage.
- Housing: Wire mesh cages in groups.
- Diet (e.g. ad libitum): food consisting of commercial pellets ad libitum.
- Water (e.g. ad libitum): Water available ad libitum.
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
0.464, 1.00, 2.15, 4.64, 10.0 and 21.5 ml/kg of body weight
No. of animals per sex per dose:
5 males per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed closely day of dosage and at least once daily there after.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Statistics:
Statistical analysis of the mortality data was by the moving average method (Weil, C.S., Biometrics 8, 249, 1952)
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6.81 mL/kg bw
Based on:
test mat.
Mortality:
Deaths were noted after 24 hours of doses 10.0 and 21.5 ml/kg.
Clinical signs:
other: Signs noted included depression, mucoid diarrhea with greenish stools. Depressed or absent righting and placement reflexes were observed in these animals which died during the night following the dosage.
Gross pathology:
Findings in animals that died included congested lungs and kidneys; stomach filled with green fluid; and small and large intestines distended with green fluid and gas. Gross autopsies performed on the surviving rats at termination showed no significant gross pathological changes.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 for male abino rats was found to be 6.81 ml/kg of body weight. The acute toxicity was evaluated using the procedures outlined in the Regulations under the Federal Hazardous Substances Labeling Act.
Executive summary:

The acute oral LD50 for male abino rats was found to be 6.81 ml/kg of body weight. The acute toxicity was evaluated using the procedures outlined in the Regulations under the Federal Hazardous Substances Labeling Act.

Additional information

Justification for classification or non-classification