1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts

Endpoint summary

Description of key information

NOAEL sub-acute (rat): 70 mg/Kg bw

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

70 mg/kg bw/day

Study duration:

subacute

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The Similar substance 02 was tested for reproduction and subacute toxicity using the OECD Test Guideline No. 422: Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on March 22nd 1996.

The value of NOAEL (No Observed Adverse Effect Level) was 70 mg/kg body weight/day both for males and females. This value was established on the basis of haematology parameters (mainly - decreased value of total erythrocyte count, haematocrit and haemoglobin, increased value of mean corpuscular volume) and biochemistry findings (mainly - increased value of sodium ions, phosphorus, bilirubin, total protein and creatinine, decreased value of potassium ions). Histopathological evaluation revealed specific target organ toxicity effect on the spleen, kidneys and intestines.

Under a 5 -days acute oral test, the Similar substance 01 resulted with a LD0 >= 1000 mg/kg bw and an LD50 > 1000 mg/kg bw.

Based on the read-across principle (read-across from supporting substance -structural analogue or surrogate), the results can be considered for the repeated dose toxicity assessment of the substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.

Justification for classification or non-classification

According to the CLP Annex 1: 3.9.2.8: effects considered not to support classification for specific target organ toxicity following repeated exposure are: small changes in clinical biochemistry, haematology or urinalysis parameters and/or transient effects, when such changes or effects are of doubtful or minimal toxicological importance.

Repeated oral administration to rats by gavage at the dose levels 70, 250 and 630 mg/kg/day did not cause mortality. 

Slight changes of body weight and body weight increment in males and females, clinical status of animals, haematological and biochemical blood parameters in males, biometry of organs (spleen) in males and females, macroscopical and microscopical structure of organs in males were detected even at the dose level 70 mg/kg/day.

However, these modulations were considered incidental, without toxicological relevance and no classification for repeated dose is warranted for the Similar substance 02.

Based on the read-across principle(read-across from supporting substance -structural analogue or surrogate), the result can be considered for the repeated dose toxicity assessment of the substance. Justification for read-across is detailed in the report attached to the IUCLID section 13.

As conclusion the registered substance is not classified for the oral repeated dose toxicity, according to CLP Regulation 1272/2008.