Registration Dossier

Administrative data

Description of key information

Oral (similar to OECD 401), rat: LD50 calculated = 1300 mg/kg bw

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:
comparable to guideline study with acceptable restrictions
Remarks:
Limited documentation. No information on analytical purity of test substance given.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Limited documentation. No information on analytical purity of test substance given.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
600, 1220, 2470 and 5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
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, gross pathology
Sex:
not specified
Dose descriptor:
LD50
Remarks:
calculated
Effect level:
1 300 mg/kg bw
Based on:
test mat.
95% CL:
840 - 2 100
Mortality:
600 mg/kg bw: 1/10 animals died
1220 mg/kg bw: 4/10 animals died
2470 mg/kg bw: 9/10 animals died
5000 mg/kg bw: 10/10 animals died
Mortality occurred in all animals within 24 h.
Clinical signs:
600 mg/kg bw: ataxia, lethargy, tremors, chromorhinorrhea, chromodacryorrhea
1220 mg/kg bw: lethargy, ptosis, piloerection, chromorhinorrhea
2470 mg/kg bw: salivation, chromorhinorrhea, ataxia
5000 mg/kg bw: coma and death
Gross pathology:
600 mg/kg bw: dark lungs (1/10), dark liver (1/10), dark kidneys (1/10) and areas of redness in intestines (1/10)
1220 mg/kg bw: dark lungs (4/10), dark liver (4/10), dark kidneys (2/10) and areas of redness in intestines (4/10) and motteled kidneys (3/10)
2470 mg/kg bw: dark lungs (9/10), dark liver (8/10), dark kidneys (2/10), areas of redness in intestines (6/10), dried blood around eyes (3/10), yellow exudate from nose and mouse (3/10), yellow portions of intestines (3/10), red portions of stomach (3/10), bloody urine in bladder (2/10), red exudate from mouth (2/10) and mottled kidneys(1/10)
5000 mg/kg bw: dark lungs (9/10), dark liver (7/10), dark kidneys (3/10) and areas of redness in intestines (6/10)
Interpretation of results:
other: Acute Tox. 4 according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study a LD50 value of 1300 mg/kg bw was derived in rats.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 300 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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

Oral

The acute oral toxicity of the test substance was assessed in rats in a study similar to OECD Guideline 401 (1977). 1, 4, 9 and 10 per 10 animals were found dead within 24 h at the applied doses of 600, 1220, 2470 and 5000 mg/kg bw, respectively. Animals of the high dose group lapsed into coma or were found in a moribund state. The LD50 value for rats was calculated to be 1300 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral toxicity of the test substance meet the criteria for Acute Tox. 4 (H302) according to Regulation (EC) 1272/2008.