Reaction mass of disodium 4-amino-6-[[4-[(2,4-diaminophenyl)diazenyl]phenyl]]-3-((E)-[4-((E)-(2,4-diaminophenyl)diazenyl]phenyl )diazenyl)-5-hydroxynaphthalene-2,7-disulphonate and disodium 4-amino-6-((E)-(4-aminophenyl)diazenyl)-3-((E)-(4-((E)-(2,4-diaminophenyl)diazenyl)phenyl)diazenyl)-5-hydroxynaphthalene-2,7-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: experimental study on similar substance

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study well documented, test procedure in accordance with OECD methods, meets generally accepted scientific principles, acceptable for assessment. GLP compliant with certificate.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate

EC Number:

229-208-1

EC Name:

Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate

Cas Number:

6428-31-5

Molecular formula:

C34H29N13O7S2.2Na

IUPAC Name:

disodium 4-amino-3,6-bis({4-[(2,4-diaminophenyl)diazenyl]phenyl}diazenyl)-5-hydroxynaphthalene-2,7-disulfonate

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: Firma Charles River Wiga Gmbh Deutschland, Sulzfeld
- Weight at study initiation: The weights of the male rats are: 461,2 g ± 23,3 g. The weights of the female rats are: 275,2 g ± 11 g.
- Fasting period before study: 22 h
- Housing: 3 animals per cage Type 3 Makrolon
- Diet: Altromin 1326 ad libitum
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20,5 - 22,5
- Humidity (%): 25-40
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

600

Doses:

Single dose: 2000 mg/kg

No. of animals per sex per dose:

6 male and 6 female

Control animals:

yes

Statistics:

Not applicable.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality

Clinical signs:

other: Diarrhoea occurred in 3 male rats 5 hours after exposure to the test substance. Discoloration of the faeces occurred 5 day after the exposure.

Gross pathology:

No damage to any organs.

Other findings:

The exposure to the tested substance did not influencing the behaviour of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The tested item was found to be non toxic for oral exposure with a LD50 > 2000 mg/kg bw.

Executive summary:

The acute oral toxicity was assessed following the OECD 401.

The results show no toxicity with a LD value > 2000 mg/kg.