trisodium bis[3-[1-(3-chlorophenyl)-5-(hydroxykO)-3-methyl-1H-pyrazol-4-yl]diazenyl}-4-(hydroxy-kO)5-nitrobenzenesulfonato(3-)]chromate(3-)

Endpoint summary

Description of key information

LD50> 2000 mg/kg.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study well documented, test procedure in accordance with OECD methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 161-201 g
- Age: 7-8 weeks
- Fasting period before study: 22 h
- Housing: single animale per cage
- Diet: commercial rat food, NAFAG No. 890, NAFAG AG, Gossau CH ad libitum
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity: 55 ± 15 %
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
- approx. 15 air changes/h

Route of administration:

oral: gavage

Vehicle:

water

Doses:

Single dose: 2000 and 5000 mg/kg of the compound bw.
Volume: 10 ml/kg for lower dose and 20 ml/kg for higher dose

No. of animals per sex per dose:

5 for each sex
Total animals number : 20

Control animals:

not specified

Statistics:

Not applicable.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

All the animals of both sexes in the 5000 mg/kg groups died after 1 day of the post-exsposure period.

Clinical signs:

Dyspnea, slight to moderate ruffled fur and abnormal body positions were seen, being common symptoms in acute tests.
Additionally diarrhea was detected in the animals of the 2000 mg/kg dose group up to day 2 after the administration.
Sedation and diarrhea was observed in the animals of the 5000 mg/kg bw dose group.

Body weight:

Determined at day: 1, 7 and 14 and at each death.

Gross pathology:

No change in any organs and tissues.

Interpretation of results:

other: not classified

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

LD50 > 2000 mg/kg bw.

Executive summary:

The results show no toxicity with a LD 50 value > 2000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 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

Justification for classification or non-classification

Acute oral toxicity

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:

Oral (mg/kg body weight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 values are > 2000 mg/kg/body weight.

The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.