2,7-Naphthalenedisulfonic acid, 4-amino-3,6-bis[2-[4-(ethenylsulfonyl)phenyl]diazenyl]-5-hydroxy-, sodium salt (1:2)

Endpoint summary

Description of key information

The test substance is practically non-toxic.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

May to July 1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form

Principles of method if other than guideline:

Internal Guideline Hoechst AG

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: mixed-race albino

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Own breeding facility
- Weight at study initiation: 80 to 128 g
- Fasting period before study: 12 hours prior administration
- Housing: 10/cage
- Diet: Altromin rat standard diet ad libitum
- Water: tap ad libitum
- Acclimation period: -

IN-LIFE DATES: From: 01. Jun. 1965 To: 25. Jun. 1965

Route of administration:

oral: gavage

Vehicle:

other: 2% starch

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 40, 50, and 60 mL/kg bw
- Justification for choice of vehicle: provide homogeneous suspension

Doses:

10, 12.5, 15 g/kg body weight

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

Weight range at start: 80 to 128 g
Test substance concentration: 25%
Withhold of food 12 hours prior to test substance administration
Observation period: 7 days after test substance administration

Statistics:

Determination of LD50: graphical in probability grid

Preliminary study:

3.2 and 10 g/kg in 3 female rats/dose group.
No deaths occurred.
Clinical signs: diarrhea, test compound in feces

Sex:

female

Dose descriptor:

LD50

Effect level:

> 14 000 - < 14 500 mg/kg bw

Mortality:

no deaths at 10000 and 12500 mg/kg. 9/10 rats at 15000 mg/kg died; seven rats within 24 hours, one on Day 9 and one on Day 12.

Clinical signs:

other: 10000 mg/kg: NAD 12500 mg/kg: diarrhea, prone position and ataxia in some animals 15000 mg/kg: diarrhea, test compound in feces

Gross pathology:

no data

Other findings:

no data

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: other: Spector - Handbook of Toxicology

Conclusions:

LD50 above 5000 mg/kg bw.
No classification required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

14 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Due to the physico-chemical properties of the test item, dermal penetration is most unlikely. Due to the good water solubility, the toxicologically most relevant route of exposure is the oral one. Single dose studies with oral gavage of Reactive Black 5 at doses up to 15000 mg/kg body weight are available. These studies showed that Reactive Black 5 has a very low toxicity with an oral LD50 between 14000 and 14500 mg/kg body weight. It is therefore scientifically not justified to perform an additional acute toxicity study with dermal application for Reactive Black 5 bis-vinyl.

Inhalative exposure of workers to Reactive Black 5 bis-vinyl is very unlikely, as production and spray drying is done in a closed process without isolation of reaction products. The isolated product are dust free granules or dedusted powders (non-dusty solid) therefore inhalative exposure of down-stream users is very unlikely, too.

Justification for classification or non-classification

Based on the above stated assessment of the acute oral toxicity the substance does not need to be classified for Acute Oral toxicity according to GLP (Regulation (EC) No 1272/2008 of The European Parliament and of The Council) as implementation of UN-GHS in the EU.