Registration Dossier

Administrative data

Description of key information

Acute oral Toxicity:

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: usual manner
Principles of method if other than guideline:
The test substance is administered orally by gavage in graduated doses to several groups of experimental animals for 5 days, one dose being used per group. Subsequently observations of effects and deaths are made after 24 hours, 2 days, 3 days, 4 days, 5 days followed by an post observation period of 10 days (= 15 days after the first dosage).
GLP compliance:
no
Test type:
standard acute method
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no further information available
Doses:
1000, 2000, 4000 and 8000 mg/kg bw
No. of animals per sex per dose:
10 animals per dosage group
Control animals:
no
Details on study design:
no further information available
Sex:
not specified
Dose descriptor:
LD50
Remarks:
observation period: 24 hours
Effect level:
5 640 mg/kg bw
Sex:
not specified
Dose descriptor:
other: LD90
Remarks:
observation period: 24 hours
Effect level:
7 080 mg/kg bw
Sex:
not specified
Dose descriptor:
other: LD10
Remarks:
observation period: 24 hours
Effect level:
4 500 mg/kg bw
Sex:
not specified
Dose descriptor:
discriminating dose
Remarks:
treatment over 5 days and 10 days post observation period
Effect level:
3 000 mg/kg bw
Mortality:
24 hours after the first administration:
8000 mg/kg bw: 10/10 dead
4000 mg/kg bw: 0/10
2000 mg/kg bw: 0/10
1000 mg/kg bw: 0/10

Clinical signs:
sedation, hypoventilation
Body weight:
decreased body weight gain
Gross pathology:
not examined

Although the LD50 value was calculated from a study with repeated administration (5 days), taken the mortality data 24 hours after the first administration, this value allows for a reliable assessment of the acute oral toxicity. The LD50 value is still above 2000 mg/kg bw even if the dosage was extented over five days (post observation period: 10 days).

Executive summary:

The tests were carried out in the usual manner (oral, gavage), 10 animals per dosage group. The lethal doses were determined by the computer method developed by Dr S. Wolf. The LD 10, LD 50, and LD 90 are calculated on the basis of the mortality data reported 24 hours after administration of a single dose. the LD 50 value for the test substance was reported to be > 2000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: usual manner
Principles of method if other than guideline:
no further information available
GLP compliance:
no
Test type:
standard acute method
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
no further information available
Doses:
1000, 2000, 4000, 8000 mg/kg bw
No. of animals per sex per dose:
10 animals per dosage group
Control animals:
no
Details on study design:
no further information available
Sex:
not specified
Dose descriptor:
LD50
Remarks:
observation period: 24 h and 10 days
Effect level:
8 500 mg/kg bw
Sex:
not specified
Dose descriptor:
other: LD90
Remarks:
observation period: 24 h and 10 days
Effect level:
10 600 mg/kg bw
Sex:
not specified
Dose descriptor:
other: LD10
Remarks:
observation period: 24 h and 10 days
Effect level:
6 700 mg/kg bw
Mortality:
4000 ersterTag 5/10
Clinical signs:
sedation, hypoventilation
Body weight:
decrease in body weight gain
Gross pathology:
no information available
Executive summary:

The tests were carried out in the usual manner (oral, gavage), using 10 mice per dosage group. The lethal doses were determined by the computer method developed by Dr S. Wolf. The LD 10, LD 50, and LD 90 are stated for observation period of 24 h and 10 days. The LD 50 value for the test substance was reported to be 8500 (+- 670) mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Although both studies do not meet the recent requirements they provide a convincing picture of the acute oral toxicity of the substance.

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

Based on the study results for acute oral toxicity no classification according to Regulation (EC) No. 1272/2008 (CLP), ANNEX I, is warranted.