Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 1989-February 1990

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:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The test was carried out in 1990. The test meets National standards method with acceptable restrictions.

GLP compliance:

no

Test type:

other: unknown

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

277-616-3

EC Name:

Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

73816-74-7

Molecular formula:

C28H24ClN7O10S3.3Na

IUPAC Name:

trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

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): Reactive Red 45:1
- Physical state: red solid powder
- Analytical purity: 85% (w/w)
- Impurities (identity and concentrations): NaCl (CAS: 7647-14-5) 15% (w/w)
- Lot/batch No.: 7010
- Expiration date of the lot/batch: unlisted
- 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

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Test animals:
Age and weight at the study initiation: weight -137-160 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: 20% aqua solution

Doses:

3.981 g/kg, 5.020 g/kg, 6.310 g/kg, 7.943 g/kg

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy finding

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

6.16 other: g/kg

Based on:

not specified

95% CL:

> 5.637 - < 6.732

Mortality:

Death occurred till 3 hours after application.
Number of deaths of each level:
3.981 g/kg: 0
5.020 g/kg: 2
6.310 g/kg: 4
7.943 g/kg: 10

Clinical signs:

diarrhea in animals of all dose levels, in 2 hours till 2nd day- languor in all dose levels except the dose level 3.981 g/kg. From the 3rd day – without clinical signs of intoxication

Gross pathology:

Necropsy finding: colouration of organism in dead animals; in survivor animals – coloured liver and kidneys

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on determined value LD50 = 6.16 g/kg, the tested substance, Reactive Red 45:1, has not been classified as acute toxic by the oral route.

Executive summary:

Based on determined value LD50 = 6.16 g/kg, the tested substance, Reactive Red 45:1, has not been classified as acute toxic by the oral route.