[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid

Endpoint summary

Description of key information

LD50(oral, rat, 24h)>5000 mg/kg of body weight
LD50(dermal, rabbit, 24h)>2000 mg/kg of body weight
LC50(inhalation, rat, 1hour,)> 2480mg/m3 air

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

2 480 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral toxicity:

An acute oral toxicity test as a key study was conducted in young albino rats(Huntingdon Research Center, 1976). Ten Sprague-Dawley rats were exposed at the level of 5000 mg/kg of body weight. Body weights were recorded at dosing and on day 14. Observations were made frequently after dosing and daily until termination. Animals sacrificed at Day 14 were subjected to a gross examination of the viscera. Based on a 100% survival rate at 5000mg/kg of body weight, test article was considered as non-toxic. The LD50 would be estimated at greater than 5000 mg/kg of body weight

The results of another supportive study were consistent with that of the key study, where test article was applied at limit level of 5000 mg/kg of body weight in ten rats for 14-day test period. No untoward reactions occurred. No adverse effects were observed in the body weight gain, clinical signs and gross pathology.

Inhalation toxicity:

A study (Huntingdon Research Center,Project number G4226-11) was performed to evaluate the acute inhalation toxicity of test article. Ten male and ten female rats were exposed for a single one hour aerosol of test article at an actual concentration of 2.48 milligrams per liter of air. All animals were held for 14 days post-exposure for observations of latent effects. There were no deaths or signs of toxicity during the exposure or the fourteen day observation period. All animals gained weight normal1y throughout the experiment. Upon inspection, the lungs from the majority of male and female rats exhibited a blue/black tint. Therefore, one hour LC50 for test article is estimated to be greater than 2.48 mg/L.

Dermal toxicity:

Six non-GLP dermal tests following OECD guideline 402 was conducted by two facilities (3 for Huntingdon Research Center, 1976; 3 for Product Safety labs - a division of nutrition international Inc., 1981), whichshowed that no signs of toxicity was observed following a single,semioccluded application of the test material to intact rabbits’skin for 24hrs,at a dose level of 2000 mg/kg bodyweight. The acute dermal median lethal dose (LD50) of the test material in the rabbits was found to be greater than 2000 mg/kg.bw.

Based on the information as above, test article cannot cause any acute treatment-related effect in the animals.

Justification for classification or non-classification

Based on the available data, test article cannot be classified in accordance with CLP(Regulation No.1272/2008).