Sodium 4-(3-methyl-4-(4-methyl-3-(phenylaminosulphonyl)phenylazo)-5-hydroxypyrazol-1-yl)benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

may-august 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards and acceptable for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The study report contains the limited information on the test conditions because the study has been performed in 1980. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.

GLP compliance:

no

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-(3-methyl-4-(4-methyl-3-(phenylaminosulphonyl)phenylazo)-5-hydroxypyrazol-1-yl)benzenesulphonate

EC Number:

228-810-1

EC Name:

Sodium 4-(3-methyl-4-(4-methyl-3-(phenylaminosulphonyl)phenylazo)-5-hydroxypyrazol-1-yl)benzenesulphonate

Cas Number:

6359-85-9

Molecular formula:

C23H21N5O6S2.Na

IUPAC Name:

sodium 4-(3-methyl-4-(4-methyl-3-(phenylaminosulphonyl)phenylazo)-5-hydroxypyrazol-1-yl)benzenesulphonate

impurity 1

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

sodium chloride

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Acid Yellow 25- Physical state: yellow solid, powder- Analytical purity: 95 % (w/w)- Impurities (identity and concentrations): 5%(w/w) NaCl (CAS No. 7647-14-5 - Lot/batch No.: 7003/2007- Expiration date of the lot/batch: 2 years/June 2018- Storage condition of test material: The test substance should be stored in dry room in dark in closed container at the room temperature.

Test animals

Species:

rat

Sex:

male

Details on test animals or test system and environmental conditions:

-Weight at study initiation: 110-150 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

olive oil

Details on oral exposure:

-Concentration in vehicle: 20% w/w

Doses:

6.310 g/kg7.943 g/kg10 g/kg12.59 g/kg

No. of animals per sex per dose:

10 animals per dose

Details on study design:

Duration of observation period following administration: 14 days- Frequency of observations and weighing: no data- Necropsy of survivors performed: yes- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

9.641 other: g/kg bw

Based on:

test mat.

95% CL:

> 8.108 - < 11.46

Mortality:

Number of deaths of each level:6.310 g/kg: 1:107.943 g/kg: 2:1010.00 g/kg: 6:1012.59 g/kg: 8:10

Clinical signs:

clinical signs – diarrhea

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on determined value LD50 = 9.641 g/kg, the tested substance Acid Yellow 25 has not beenclassified as acute toxic by the oral route.