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Description of key information

No deaths were observed up to oral dose levels of 10000 mg/kg bw and dermal dose levels of 2500 mg/kg bw in rats or at inhalational exposure at saturation concentration for 8 hours.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif RAIf strain
Sex:
male/female
Details on test animals and environmental conditions:
Healthy random bred rats of the Tif RAI f strain raised on our premises were used for these experiments. They were kept at a room temperature of 22±1°C, at a relative humidity of 55*5% and on a 14 hours light cycle day. They received ad libitum a standard diet of pellets - No. 890, Nafag Gossau SG - and water. Prior to treatment the rats were acclimatized to our laboratories for a minimum of 5 days. The mean initial body weight of the groups ranged from 90 to 100 grams.
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10%, 25%, 30%
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: test item is neither soluble in water nor in organic solvents, thus water as vehicle for the suspension was chosen


DOSAGE PREPARATION (if unusual): suspension
Doses:
Nominal concentrations: 1000/3000/10000/15000 mg/kg
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: pre-test day and on day 15 of test
- Necropsy of survivors performed: yes, autopsies were performed on those that died and on surivor at day 15 of the study.
- Other examinations performed: clinical signs, body weight
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks:
59% active ingrediend = 8850 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 10 000 - < 15 000 mg/kg bw
Based on:
test mat.
Remarks:
59% ai
Mortality:
- At 1000 mg/kg: no deaths
- At 3000 mg/kg: no deaths
- At 10000 mg/kg: no deaths
- At 15000 mg/kg: 3/5 females and 0/5 male died
Clinical signs:
- At 1000 mg/kg: no effects
- At 3000 mg/kg: reduction in spontaneous motility and ataxia lasting >6 hours. After 24 hours no symptoms
- At 10000 mg/kg: reduction in spontaneous motility and ataxia lasting >6 hours. After 24 hours no symptoms
- At 15000 mg/kg: eduction in spontaneous motility and ataxia lasting >6 hours, muscular hypotonia, diarrhea, roughening of the coat. After 7 days no symptoms
Body weight:
Expected body weight gain was observed
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of Vat Blue 20 was > 15000 mg/kg bw in male rats and between 10000 15000 mg/kg bw in female rats.
Executive summary:

A study was performed to determine the acute oral toxicity of Vat Blue 20 on rats via oral route. Physical condition and rate of deaths were monitored throughout the whole observation period. A doses of 1000, 3000, 10000 and 15000 mg/kg bw was given by oral gavage.

Clinical signs were observed at dose levels of 3000 mg/kg bw and above. No males rats died, three female rats died at the highest dose level.

Thus, the acute oral LD50 of Vat Blue 20 was > 15000 mg/kg bw in male rats and between 10000 15000 mg/kg bw in female rats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
BASF internal guidelines followed
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
30% suspension
Doses:
10000 mg/kg
No. of animals per sex per dose:
no data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
Statistics:
NA
Preliminary study:
NA
Key result
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks:
48% ai = LD50: 4800 mg(kg bw ai
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no effects
Clinical signs:
dyspnea, hypoactivity, dark blue faeces
Body weight:
no data
Gross pathology:
no effects
Interpretation of results:
GHS criteria not met
Conclusions:
acute oral LD50 in rats is higher than 10000 mg/kg bw based on test material, and higher than 4800 mg/kg bw based on active ingredient.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Justification for classification or non-classification