Reaction mass of isomers disodium 8-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-5-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate, disodium 5-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-8-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate

Endpoint summary

Description of key information

LD50 oral > 2000 mg/kg bw
LD50 dermal > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 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 adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Additional information

The test substance was evaluated for its potential acute toxicity in rats.

 

Acute Toxicity: Oral
The substance has been tested for acute toxicity by oral route according to the OECD Guideline 423 following oral administration of 2000 mg/kg body weight.
All animals survived until the end of the study showing signs of toxicity.
The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, piloerection and half eyelid-closure. All symptoms recovered within up to 4 hours post dose. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
The acute oral LD50 was determined to be higher than 2000 mg/kg bw.

 

Acute Toxicity: Dermal
The evaluation of acute dermal toxicity has been performed according to the OECD guideline 402.
The test item at single dose of 2000 mg/kg was applied over an area which was approximately 10% of the total body surface on the dorsal area (fur was removed) of five males and five females WISTAR Crl: WI(Han) rats and held in contact with the skin by a dressing throughout 24-hour period. The vehicle used for moistening was aqua ad injectionem. At the end of the treatment period the test item was removed using aqua ad injectionem and all the animals were observed for 14 days after application. No mortality occurred during the course of the study. For male animals no body weight loss was recorded while for the females some slight body weight loss was observed in two of them and scratches were observed in one female starting on day 4 until day 12 post application. Another female was noted to have slight piloerection on some occasions and abnormal breathing on day 8 post application. No other clinical signs were noted. At necropsy no macroscopic findings were observed.

Justification for classification or non-classification

According to the CLP Regulation (EC) No. 1272/2008, 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

The oral LD50 value was established to be higher than2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).
The dermal LD50 value was established to be higher than 2000 mg/kg body weight, which exceeded the highest CLP limit for classification (dermal acute toxicity Category 4: 1000 < ATE ≤ 2000 mg/kg bw).

In conclusion, using the data obtained from oral and dermal acute toxicity, it is possible to conclude that the test substance is not classified for acute oral toxicity and acute dermal toxicity, according to the CLP Regulation (EC) No. 1272/2008.