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Description of key information

In three acute oral toxicity studies LD50 values of above 4000 mg/kg bw were determined (BASF 1969, 1970, 1972).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1969-09-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Female: 127.3 - 132.3 g; Male: 142.6 - 149.0 g
- Fasting period before study: 18 hours before treatment
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle: 20 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 2.98 mL
Doses:
0, 2000 , 4000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
At 2000 and 4000 mg/kg bw diarrhea was observed. No other treatment related findings were observed.
Body weight:
The body weight changes were similar to the changes observed in the control groups.
Gross pathology:
No gross pathological findings were observed.
Interpretation of results:
GHS criteria not met
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1970-03-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
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:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: Female: 137.7 - 149.8 g; Male: 199.7 - 214.2 g
- Fasting period before study: 18 hours before treatment
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 4.28 mL
Doses:
0, 5000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Diarrhea was observed.
Body weight:
Body weight gains were comparable to the controls.
Gross pathology:
No gross pathological findings were observed in the animals.
Interpretation of results:
GHS criteria not met
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Animals were only observed for 8 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFE (RAG, SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: in house breeder
- Age at study initiation: young adults
- Weight at study initiation: 113 - 133 g
- Fasting period before study: overnight
- Housing: groups of 5
- Diet: ad libitum, Standard diet (Nafag)
- Water: ad libitum, drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1
- Humidity (%): 55±5
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
other: water and carboxymethylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30%
Doses:
6000, 10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
Red coloured skin, urine and feces were observed in the 6000 mg/kg bw dosing group. At 10000 mg/kg bw animals further showed slight sedation.
Body weight:
Body weight gains were comparable to the controls.
Gross pathology:
No gross pathological findings were observed in the animals.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
4 000 mg/kg bw

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

In the first acute oral toxicity study, groups (6/sex) of fasted, young adult Sprague Dawley rats were given a single oral dose of the test substance diluted in water at doses of 2000 and 4000 mg/kg bw per gavage (BASF, 1969). Animals were then observed for 14 days. No mortality was observed. At both treatment levels diarrhea was observed in both male and female animals. The body weight gain was similar to the controls. No treatment related findings were observed in the necropsy. A LD50 value of 4000 mg/kg bw was determined.

In the second acute oral toxicity study, groups (6/sex) of fasted, young adult Sprague Dawley rats were given a single oral limit dose of 5000 mg/kg bw per gavage (BASF, 1970). Animals were then observed for 14 days.

No mortality was observed. Diarrhea was observed in both male and female animals. The body weight gain was similar to the controls. No treatment related findings were observed in the necropsy. A LD50 value of 5000 mg/kg bw was determined.

In the last acute oral toxicity study, groups (5/sex) of fasted, young random-bred rats (CFE strain) were given a single oral dose of the test substance diluted in water at doses of 6000 and 10000 mg/kg bw per gavage (BASF, 1972). The animals were only observed for 8 days. No mortality was observed. The animals showed red coloured skin, urine and feces at both dose levels. A slight sedation was additionally observed in the highest dosing group. No necropsy was performed. A LD50 value of above 10000 mg/kg bw was determined.

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 1272/2008. As a result the substance does not need to be classified and labelled for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.