tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Aug. 11, 1999 to Aug. 25, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

432-550-6

EC Name:

-

Cas Number:

243858-01-7

Molecular formula:

Hill formula: C25H22FN7Na4O16S5 CAS formula: C25H26FN7O16S5.4Na

IUPAC Name:

tetrasodium 2-({4-fluoro-6-[methyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-5-hydroxy-6-[2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Orange F97-0318

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: No adverse effect observed. All animals had an orange discolouration of the skin upto 6 d. In some animals this lasted upto 12 d.

Gross pathology:

No macroscopically visible changes were seen.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute dermal LD50 of the test substance was found to be >2000 mg/kg bw.

Executive summary:

A study was performed to assess the acute dermal toxicity of the test substance in Sprague Dawley rats according to the OECD Guideline 402 and EU method B.3 in compliance with GLP.

A group of rats (5 per sex) was exposed at the dose of 2000 mg/kg bw. Exposure lasted 24 h. Animals were observed for clinical signs, signs of irritation and body weight changes over a period of 14 d.

No clinical signs were observed. All animals had an orange discolouration of the skin upto 6 d. In some animals this lasted upto 12 d. No treatment related effect on body weight gain was observed. Gross pathological examination did not reveal any macroscopic abnormalities.

Under the test conditions, the acute oral LD50 of the test substance for male and females rats was determined > 2000 mg/kg bw.