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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

06 to 20 March 1980

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Internal Guideline Hoechst AG

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Black 5

IUPAC Name:

Reactive Black 5

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Remazol Schwarz GFVP 5152

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: -
- Weight at study initiation: 208 to 222 g
- Fasting period before study: 16 hours before to 2 hours after dosing
- Housing: groups caging
- Diet: Altromin 1324 ad libitum
- Water: tap ad libitum
- Acclimation period: -


IN-LIFE DATES: From: 06. Mar To: 20. Mar 1980

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/clinical signs: al least daily; body weight: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

-

Results and discussion

Preliminary study:

NA

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

no deaths

Clinical signs:

other: drowsiness, piloerection, diarrhea within 1 to 3 hours after dosing. Dark bluish discoloration of skin, feces and urine within 3 to 24 hours after dosing. Discolored skin and urine were observed during the entire observation period with decreasing intensi

Gross pathology:

slight bluish discoloration of cutis and subcutis, purple discolored kidneys

Applicant's summary and conclusion

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 necessary