Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: OECD TG 401: 1520 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
Study period:
Not reported.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No details on test material, no purity, no doses/dose volume reported, limited details on test animals and no details on environmental conditions, no individual data.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: approximately 18 hours prior to treatment
- Diet: Food was replaced in cages as soon as animals received their respective doses.
- Water: Free access to water

ENVIRONMENTAL CONDITIONS
No data.
Route of administration:
other: oral intubation
Vehicle:
unchanged (no vehicle)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain.
Statistics:
LD50 values were computed by the method of Litchfield & Wilcoxon (1949).
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 520 mg/kg bw
Based on:
test mat.
95% CL:
>= 790 - <= 1 290
Mortality:
Yes, death time 4 hours - 8 days.
Clinical signs:
Scrawny appearance.
Body weight:
No data.
Gross pathology:
No data.
Interpretation of results:
other: Acute harmful Category 4.
Remarks:
According to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The acute oral toxicity test showed a calculated LD50 of 1520 mg/kg bw.
Executive summary:

In this study performed equivalent to OECD TG 401 guideline without GLP, rats (5 males and 5 females) were administered with the substance. Death time was 4 hours - 8 days. Clinical signs observed was scrawny appearance. The acute oral LD50 for the substance in male and female rats was calculated to be 1520 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 520 mg/kg bw
Quality of whole database:
The acute oral toxicity result is of sufficient quality and adequate for this dossier.

Additional information

Acute oral:

In this study performed equivalent to OECD TG 401 guideline without GLP, rats (5 males and 5 females) were administered with the substance. Death time was 4 hours - 8 days. Clinical signs observed was scrawny appearance. The acute oral LD50 for the substance in male and female rats was calculated to be 1520 mg/kg bw.

Justification for classification or non-classification

Based on the results, the substance needs to be classified for acute oral toxicity category 4 and shall be labelled with H302: Harmful if swallowed according to EU CLP (EC No. 1272/2008 and its amendments).