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Description of key information

LD50(oral) > 15000 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:
May 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
no guideline available
Principles of method if other than guideline:
Similar to OECD Guideline 401 (Acute Oral Toxicity) with slight deviations (Cycle dark/light 14 hours).
GLP compliance:
no
Remarks:
pre GLP
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Tif: RAIf
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Basle, Toxicology/Pathology PH 2.634/CP/gk
- Weight at study initiation: Mean initial body weight: from 80 to 86 grams
- Housing: group of 5 into Macrolon cages (Type 3)
- Diet (e.g. ad libitum): ad libitum Pellets n. 890 Nafag Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±1 °C
- Humidity (%): 55 ±5 %
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %, 30 %, 25 %
Doses:
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Pre-mortem:
Dose 1000 mg/kg bw: after 30 minutes hyperreflexia
Dose 3000 mg/kg bw : ditto, after 15 minutes irregular respiration reduction in spontaneous motility, muscolar hypotonia.
Dose 10000 mg/kg bw : ditto stiff movements, piloerection.
Dose 15000 mg/kg bw : ditto laboured respiration, ataxia.
Body weight:
Dose 1000 mg/kg bw : 86 g (pre-test), 182 g (on day 15 of test)
Dose 3000 mg/kg bw : 84 g (pre-test), 179 g (on day 15 of test)
Dose 10000 mg/kg bw : 80 g (pre-test), 175 g (on day 15 of test)
Dose 15000 mg/kg bw :82 g (pre-test), 177 g (on day 15 of test)
Gross pathology:
Dose 1000 mg/kg bw : no gross organ changes observed
Other findings:
Post-mortem:
Dose 1000 mg/kg bw: no gross organ changes observed
Dose 3000 mg/kg bw : no findings
Dose 10000 mg/kg bw : blue coloured skin
Dose 15000 mg/kg bw : no findings

Acute oral toxicity in the rat of Acid Blue 025

Dose
(mg/kg bw)
Concentration
(%)
mortality Bodyweight (g) Symptoms and necropsy
absolute day of test n pre-test on day 15 of test
m f
1000 10 0/5 0/5     86 182 After 30 min. hyperreflexia lasting >6 hours. After 24 hours no symptoms. At autopsy no gross organ changes were seen.
3000 30 0/5 0/5     84 179 Ditto, after 15 min. irregular respiration, reduction in spontaneous motility, muscular hypotonia. Symptoms lasting >24 hours. After 3 days no symptoms,
10000 25 0/5 0/5     80 175 Ditto, stiff movements, piloerection. At autopsy, blue-coloured skin.
15000 25 0/5 0/5     82 177 ditto, laboured respiration, ataxia. Symptoms lasting >5 days. After 7 days no symptoms.
Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 15000 mg/kg bw
Executive summary:

The substance has been tested in rat of both sexes. The animals were observed over a period of 15 days after a single administration of the test item (1000, 3000, 10000 and 15000 mg/kg bw) by oral intubation. The test substance shows a LD50 > 15000 mg/kg bw therefore is relatively innocuous to the rat by oral administration. No mortality was observed during the test period.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw
Quality of whole database:
Method equivalent or similar to guidelines internationally accepted.

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

The substance was tested in 1977 by oral administration. The results of the test show a very high value of LD50. No death occurred during the test.

Justification for classification or non-classification

According to the CLP Regulation (EC) n. 1272/2008, acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

The substance is not classified according to table 3.1.1 of the CLP Regulation (EC) n. 1272/2008.

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