Reaction products of 6-amino-4-naphthol-2-sulfonic acid with formaldehyde and sodium metabisulfite, coupled with diazotised 5-amino-2,4-dinitrophenol, chelated with chromium (3+), sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

only two doses used

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black 071:2 - Similar Substance 02

IUPAC Name:

Acid Black 071:2 - Similar Substance 02

Test material form:

not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

suspension with 0.5% CMC in water
15-20h before application no food was administered

Doses:

2150 and 5000 mg/kg

No. of animals per sex per dose:

5 males and 5 females at 2150 mg/kg
5 males and 5 females at 5000 mg/kg

Details on study design:

Obervation period: 14 days

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

act. ingr.

Mortality:

no mortality was observed for both male and females at each dose up to 14 days of observation

Clinical signs:

other: Black faeces and diahrrea were observed at 5000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Under the experimental conditions LD50 > 5000 mg/kg bw

Executive summary:

The substance was tested for acute oral toxicity following a guideline similar to OECD 401 wiht only two doses tested. Male and females were adminsiterd 2150 and 5000 mg/kg bw and observed up to 14 days, and no martality was observed. The LD50 under the experimental conditions is 5000 mg/kg bw.