Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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