Sodium bis[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From November 19, 1982 to December 7,1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

The complete read across justification is detailed in section 13. Source study has reliability 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

1978

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf/Switzerland
- Age at study initiation: male, 7 weeks; female, 9 weeks
- Weight at study initiation: male, 211-252 g, female 168-187 g
- Housing: animals were caged in group of 5 in Macrolon cages type 3 with wire mesh tops and standardised granulated soft wood bedding
- Diet: pelleted standard kliba 23/341/1, rabbit maintenance diet defined for acceptable contaminant level, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours cycle dark/light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE 2 % solution of CMC(carboxymethylcellulose natrium salt purum) in distilled water:
- 10 ml at 1000 mg/kg bw
- 20 ml at 5000 mg/kg bw

Doses:

1000, 5000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations:
1. bodyweights: at day of administration and day 7 and 14 after administration;
2. mortality: 5 times during the first day and daily thereafter;
3. symptoms on general behaviour, respiration, eye, nose, motility, body position, motor susceptibility, skin: 5 times at day 1 and then daily for the nature, onset, severity and duration of all gross or visible toxic or pharmacological effects as well as rate and time of death.
- Necropsy of survivors performed: yes

Statistics:

The logit model could not be applied to the observed rates of death. The LD50 was calculated without use of a statistical model by estimation.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

At the dose of 1000 mg/kg bw only ruffled fur was noted in male and female rats. This symptom disappeared within 14-day observation period.
At the dose of 5000 mg/kg bw dyspnoea, curved body position and ruffled fur were noted in male and female rats. These symptoms disappeared within 14-day observation period.

Gross pathology:

No pathological changes.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

The acute oral LD50 in rats of both sexes observed over period of 14 days was estimeted to be greater than 5000 mg/kg bw.

Executive summary:

Method

Acute oral toxicity study in rats administered at doses of 1000 and 5000 mg/kg bw. 5 animals per sex per dose were used and observed for 14 days after dosing.

Results

The following death rate was observed:

0 % at 1000 mg/kg

0 % at 5000 mg/kg

The acute oral LD50 in rats of both sexes observed over period of 14 days was greater than 5000 mg/kg bw.