Chromate(2-), [2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-sulfobenzoato(3-)]-, lithium sodium

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chromate(2-), [2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-sulfobenzoato(3-)]-, lithium sodium

EC Number:

288-678-6

EC Name:

Chromate(2-), [2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-sulfobenzoato(3-)]-, lithium sodium

Cas Number:

85865-79-8

Molecular formula:

C34H23CrLiN8NaO9S

IUPAC Name:

Chromate(2-), [2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-sulfobenzoato(3-)]-, lithium sodium

Test material form:

solid: particulate/powder

Details on test material:

Acid Yellow 232

Test animals

Species:

rat

Strain:

Wistar

Remarks:

TNO W 74

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann (Borchen)
- Age at study initiation: male: 9 weeks, female: 14weeks
- Weight at study initiation: male: 173-184g; female: 163-185g
- Housing: in groups of 5 in Makrolon type III cages
- Diet (e.g. ad libitum): Altromin (R) 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

administered at a constant application volume of 30 mL/kg bw

Doses:

3.1 and 5 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of application: multiple observations; during 14 days observation: twice per working day, once on weekend and holiday; weighing at application day and after observation period
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

5 g/kg bw: 1 female animal died 2 days after application

Clinical signs:

3.1 g/kg bw: no clinical signs
5.0 g/kg bw: bad general condition, diarrhoea, nausea

Body weight:

not affected

Gross pathology:

no effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test substance for acute oral toxicity to female and male rat was determined to be > 5000 mg/kg bw.
The substance is not classifiable according to CLP criteria

Executive summary:

An oral acute toxicity study with Acid Yellow 232 was performed at dose levels of 5000 and 3100 mg/kg bw in 5 male and 5 female rats per group.

At 5000 mg/kg bw, the following clinical signs were observed: impaired general condition, diarrhoea, and nausea. These clinical signs started directly after application, were of minor severity and lasted until Day 5.

One female rat at 5000 mg/kg bw died on Day 2.

The dose level of 3100 mg/kg bw were tolerated without any adverse effects.

Body weight development was not affected by test substance administration.

The acute oral LD50 was determined to be higher than 5000 mg/kg bw based on test material. This equals to higher than 3400 mg/kg bw based on active ingredient.