Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 2 acute oral toxicity studies as- WoE 2 and WoE 3.
Acute oral toxicity test was carried out to study the effects of the test chemicals on rodents.
GLP compliance:
not specified
Test type:
other: not specified
Limit test:
no
Species:
rat
Strain:
other: 2. Osborne-Mendel 3. Osborne-Mendel
Sex:
male/female
Details on test animals and environmental conditions:
1. TEST ANIMALS
- Fasting period before study: Rats were fasted for approximately 18 hr prior to treatment.
- Diet (e.g. ad libitum): The food was replaced in cages as soon as animals received their respective doses.
- Water (e.g. ad libitum): ad libitum
3. TEST ANIMALS
- Fasting period before study: Rats were fasted for approximately 18 hr prior to treatment.
- Diet (e.g. ad libitum): The food was replaced in cages as soon as animals received their respective doses.
- Water (e.g. ad libitum): ad libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
not specified
Doses:
2. 2480 (Range of 2100-2930mg/kg bw)
3. 6160 mg/kg (Range of 4400-8630mg/kg bw)
No. of animals per sex per dose:
2. Groups of 10/sex
3. Groups of 10/sex
Control animals:
not specified
Details on study design:
2. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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.
- Other examinations performed: Animals were observed for general clinical signs.
3. - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 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.
- Other examinations performed: Animals were observed for general clinical signs.
Statistics:
2. LD50's were computed by the method of Litchfield & Wilcoxon (1949).
3. LD50's were computed by the method of Litchfield & Wilcoxon (1949).
Preliminary study:
not specified
Sex:
male/female
Dose descriptor:
LD50
Remarks:
2
Effect level:
2 480 mg/kg bw
Based on:
test mat.
95% CL:
> 2 100 - < 2 930
Remarks on result:
other: 50% mortality was observed
Sex:
male/female
Dose descriptor:
LD50
Remarks:
3
Effect level:
6 160 mg/kg bw
Based on:
test mat.
95% CL:
> 4 400 - < 8 630
Remarks on result:
other: 50% mortality was observed
Mortality:
2. 50% mortality was observed at 2480 mg/kg bw, within 2hr to 4 days of observation period.
3. 50% mortality was observed at 6160 mg/kg bw within 4hr to 9 days of observation period.
Clinical signs:
2. Depression, coma on high doses, scrawny appearance for 3-4 days was observed in animals which recovered within 7 days.
3. Clinical signs such as, depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment was observed in treated rats.
Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified
Interpretation of results:
other: Not classified
Conclusions:
According to CLP regulation the given test chemical cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.
Executive summary:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for the given test chemical. The studies are summarized as below -

 

Acute oral toxicity study of test chemical was conducted in Groups of 10 male and female Osborne-Mendel rats at the concentration of 2480 (Range of 2100-2930mg/kg bw). 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. Animals were observed for general clinical signs. LD50's were computed by the method of Litchfield & Wilcoxon (1949). 50% mortality was observed at 2480 mg/kg bw, within 2hr to 4 days of observation period. Depression, coma on high doses, scrawny appearance for 3-4 days was observed in animals which recovered within 7 days. Therefore, LD50 value was considered to be 2480 mg/kg bw, with 95% confidential limit of 2100-2930 mg/kg bw, when male and female Osborne-Mendel rats were treated with test chemical via oral gavage route.

 

The above study is supported with the data available in publication for the given test chemical. The reported study was designed and conducted to determine the acute oral toxicity profile in Groups of 10 male and female Osborne-Mendel rats at the concentration of 6160 mg/kg (Range of 4400-8630mg/kgbw). 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. Animals were observed for general clinical signs. LD50's were computed by the method of Litchfield & Wilcoxon (1949). 50% mortality was observed at 6160 mg/kg bw within 4hr to 9 days of observation period. Clinical signs such as, depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment was observed in treated rats. Therefore, LD50 value was considered to be 6160 mg/kg bw, with 95% confidential limit of 4400-8630 mg/kg bw, when male and female Osborne-Mendel rats were treated with test chemical via oral gavage route.

  

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from handbook or collection of data.

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

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for the given test chemical. The studies are summarized as below -

 

Acute oral toxicity study of test chemical was conducted in Groups of 10 male and female Osborne-Mendel rats at the concentration of 2480 (Range of 2100-2930mg/kg bw). 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. Animals were observed for general clinical signs. LD50's were computed by the method of Litchfield & Wilcoxon (1949). 50% mortality was observed at 2480 mg/kg bw, within 2hr to 4 days of observation period. Depression, coma on high doses, scrawny appearance for 3-4 days was observed in animals which recovered within 7 days. Therefore, LD50 value was considered to be 2480 mg/kg bw, with 95% confidential limit of 2100-2930 mg/kg bw, when male and female Osborne-Mendel rats were treated with test chemical via oral gavage route.

 

The above study is supported with the data available in publication for the given test chemical. The reported study was designed and conducted to determine the acute oral toxicity profile in Groups of 10 male and female Osborne-Mendel rats at the concentration of 6160 mg/kg (Range of 4400-8630mg/kgbw). 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. Animals were observed for general clinical signs. LD50's were computed by the method of Litchfield & Wilcoxon (1949). 50% mortality was observed at 6160 mg/kg bw within 4hr to 9 days of observation period. Clinical signs such as, depression, scrawny appearance, porphyrin-like deposit around eyes and nose for a week after treatment was observed in treated rats. Therefore, LD50 value was considered to be 6160 mg/kg bw, with 95% confidential limit of 4400-8630 mg/kg bw, when male and female Osborne-Mendel rats were treated with test chemical via oral gavage route.

  

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

 

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.