Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium

Endpoint summary

Description of key information

LD50 = 4425 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:

November 27, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: [yes/no]
- Age at study initiation: 7 to 8 weeks old
- Fasting period before study: overnight before treatment
- Housing: animals were housed in groups of 5 in Macrolon cages (type 3), individually marked with picric acid.
- Diet: ad libitum rat food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: a minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2° C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 10 hours light cycle day

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Lot/batch no. (if required): Fluka AG, Buchs SG, Art. 81170

Doses:

10 and 20 ml/kg bw

No. of animals per sex per dose:

5 per sex per dose

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals weight at day 1, 7 and 14
- Necropsy of survivors performed: yes. The surviving animals recovered within 8 days.
They were submitted to a necropsy whenever they died, survivors at the end of the observation period.
- Other examinations performed: clinical signs, body weight.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 425 mg/kg bw

Based on:

test mat.

Mortality:

see table attached below

Clinical signs:

see table attached below

Body weight:

see table attached below

Gross pathology:

No substance related gross organ changes were seen.

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 = 4425 mg/kg bw

Executive summary:

Method

The acute Oral Toxicity of the test substance has been investigated according to a procedure similar to the OECD guideline 401.

Results

LD50 = 4425 (3137-7295) mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 425 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

Two studies have been reported that give information about Acute Oral Toxicity. In both studies the Acute Oral Toxicity of the test substance has been investigated according to a procedure similar to the OECD guideline 401.

In the key study the LD50 is 4425 (3137-7295) mg/kg bw while in the supporting study the LC50 value is 13120 in female rats and 16720 in male rats.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 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. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

The LD50 in the key study is 4425 mg/kg bw. This value is over the limit of classification indicated in the CLP Regulation (EC 1272/2008), therefore the test substance is not classified.