Registration Dossier

Administrative data

Description of key information

Oral: The oral LD50 value for the test substance was found to be 5000 mg/kg bw.

Dermal: The dermal LD50 value for the test substance was found to be greater than 5000 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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
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: mortalities were recorded daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
The number of deaths were used to calculate the LD50 value.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
3 males died on day 1,
1 female died on day 2.
Clinical signs:
Diuresis, crawling on stomach, slowed coordination, pilo erection, prostration, coma and death were observed. The surviving animals showed signs of recovery on the 3rd day.
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study the LD50 value was determined to be >5000 mg/kg bw.
Executive summary:

An acute oral toxicity study was conducted on 10 rats (5 male and 5 female animals). The test material was applied in one (limit) concentration of 5000 mg/kg bw by gavage. The animals were observed for a period of 14 days. Symptoms that were observed during this period were diuresis soon after dosing, crawling, slowed coordination, pilo erection, morbidity, prostration, coma and death. 3 males died on day 1, one female died on day 2. The surviving animals showed signs of recovery on the third day of observation.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Summary of study results, basic information given, sufficient for assessment.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
other: albino
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount applied: 5 g/kg bw

Duration of exposure:
no data
Doses:
no data
No. of animals per sex per dose:
3 animals with intact skin and 3 animals with abraded skin were tested.
Control animals:
not required
Statistics:
The LD50 was calculated based on the test results.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 animals of the intact skin group and 1 animal of the abraded skin group died on day 1.
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 was found to be greater than 5000 mg/kg bw.
Executive summary:

An acute dermal toxicity study was conducted on 6 rabbits. The test material was applied in one (limit) concentration of 5000 mg/kg bw to the intact skin of 3 of the test animals, test sites on the other animals were abraded before application. As a result, 2 rabbits died (one of the intact-skin test group and one of the abraded-skin test group). Morbidity, prostration and coma were observed before death. Based on the available data, the LD50 was determined to be greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Summary of study results, basic information given, sufficient for assessment

Additional information

Oral

An acute oral toxicity study was conducted on 10 rats (5 male and 5 female animals). The test material was applied in one (limit) concentration of 5000 mg/kg bw by gavage. The animals were observed for a period of 14 days. Symptoms that were observed during this period were diuresis soon after dosing, crawling, slowed coordination, pilo erection, morbidity, prostration, coma and death. 3 males died on day 1, one female died on day 2. The surviving animals showed signs of recovery on the third day of observation.

Dermal

An acute dermal toxicity study was conducted on 6 rabbits. The test material was applied in one (limit) concentration of 5000 mg/kg bw to the intact skin of 3 of the test animals, test sites on the other animals were abraded before application. As a result, 2 rabbits died (one of the intact-skin test group and one of the abraded-skin test group). Morbidity, prostration and coma were observed before death. Based on the available data, the LD50 was determined to be greater than 5000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighth time in Regulation (EU) No 2016/918.