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Description of key information

Key study: Acute toxicity via oral: Test method according to OECD  guideline 423 and EU method B.tris under GLP conditions. 2000 mg/kg produced death of all three animals in four hours, in contrast, animals receiving 200 mg/kg did not show clinical effects or mortalities.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to 96/54/EG, B.tris (Acute-toxische-Klassen--Methode); OECD 423. GLP study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
other: 96/54/EG
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Route of administration:
oral: drinking water
Vehicle:
water
Remarks:
Purified water.
Doses:
200 and 2000 mg/kg
No. of animals per sex per dose:
200 mg/kg: 3 males and 3 females
2000 mg/kg: 3 males.
Control animals:
not specified
Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed: body weights, clinical effects, gross pathology.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Mortality:
2000 mg/kg: all three animals died in the four hours of treatment.
200 mg/kg: 3 males and 3 females: no mortalities were observed.
Clinical signs:
200 mg/kg: 3 males and 3 females: no clinical effects were observed.
2000 mg/kg: Relief, lateral extension, dysponoea, piloerection and coma were observed prior to death.
Body weight:
200 mg/kg: The treatment did not show any influence on the body weight of the animals.
Gross pathology:
During necropsy, no visible anomalies in the animals were observed
Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance caused death of 3/3 animals after a single exposure at 2000mg/kg.
Executive summary:

A acute toxicity test was performed according to 96/54/EG, B.tris (Akute-toxische-Klassen-Methode); OECD 423. Groups of 3 male or female rats were exposed to the test substance at concentration of 200 (male and female groups) and 2000 mg/kg (male group) in purified water. All three male rats died in four hours of treatment of 2000 mg/kg. Relief, lateral extension, dysponoea, piloerection and coma were observed prior to death. The groups (3 males and 3 females) receiving 200 mg/kg did not show clinical effects and no mortalities were observed. The treatment did not show any influence on the body weight of the animals. During necropsy no visible anomalies in the animals were observed.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
200 mg/kg bw
Quality of whole database:
The study is GLP compliant and has high quality (Klimish score 1).

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

Key study: A acute oral toxicity test was performed according to 96/54/EG, B.tris (Akute-toxische-Klassen-Methode); OECD 423. Groups of 3 male or female rats were exposed to the test substance at concentration of 200 (male and female groups) and 2000 mg/kg (male group) in purified water. All three male rats died in four hours of treatment of 2000 mg/kg. Relief, lateral extension, dysponoea, piloerection and coma were observed prior to death. The groups (3 males and 3 females) receiving 200 mg/kg did not show clinical effects and no mortalities were observed. The treatment did not show any influence on the body weight of the animals. During necropsy no visible anomalies in the animals were observed.


Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

Given that 2000 mg/kg produced death of all three animals in four hours and, in contrast, animals receiving 200 mg/kg did not show clinical effects or mortalities. The DL 50 is between those limits:

200 mg/kg < DL50 < 2000 mg/kg.

The substance is classified for acute oral toxicity Category 4.