mixture of two components: 1. N-(1,3- dimethylbutyl)-N´- phenyl-p-phenylenediamine 2. N1-(1,3-dimethylbutyl)- N4-(4-(1-methyl-1- phenylethyl)phenyl)ben zene-1,4-diamine

Endpoint summary

Description of key information

The acute oral toxicity of Dusantox L was evaluated in a GLP and by OECD 401. In study 5 males and 5 females rats were dosed with 2000 mg/kg by gavage. LD50 for Acute toxicity oral is >2000 mg/kg bw for male and female.
Acut toxicity inhalation : was not performed.
The acute dermal toxicity of Dusantox L was evaluated in a GLP and by OECD 402. LD50 for Acute dermal toxicity is >2000 mg/kg bw for male and female.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute Oral toxicity:

The acute oral toxicity of Dusantox L was evaluated in a GLP and by OECD 401. In study 5 males and 5 females rats were dosed with 2000 mg/kg by gavage.

LD50 for Acute toxicity oral is >2000 mg/kg bw for male and female.

The common dose for both sexes LD50 is higher than 2ml/kg i.e. 2037mg/kg.
From the clinical point of view the tested substances caused temporary health disorders mainly at males. They  were
characterised by rapid formation and regression. The morbid-anatomical diagnosis was practically negative for 14 days
after application. So after one-shot peroral aplication the substance did not cause irreparable changes in the organism

Signs of toxicity related to dose levels: Males: The clinical symptoms of intoxication were observed in four animals- from the 4th to the 7th day, in one animal until eighth day after administration. The animals had motional distresses, the distresses in reaction to impulses,the easy effluences from the eyes and nostrils were detected, the intake of food was delimited and the exaggeration was also detected. On the 9th day after application the visible symptoms of health disorder were finished. No animal was died. Female: Negative impact of tested substance was not so strong in the female group. Moderate health disorders were observed in four animals from the 4th to the 6th day and in one animal until 7th day after the application. The animals showed the decreased reactions to the impulses, their breathing was slow and they did not accept the food. No visible clinical symptoms of intoxication were observed on the 8th day after application. No animal died.

Acut toxicity inhalation : was not performed. Exposure by inhalation is not probable.

Acute dermal toxicity:

LD50 for Acute toxicity dermal is >2000 mg/kg bw for male and female.

The common dose for both sexes LD50 is higher than 2ml/kg , i.e. 2037 mg/kg.

Signs of toxicity related to dose levels: During 14 days observantion period the percentage of the mortality was accounted. Futher the body weight was found out at the beginning and at the end of the experiment and from the difference the increase and the loss were calculated. The clinical symptoms of intoxication were observed next the application, in 30 minutes, in 3 hours, next morning and in the afternoon and further days once a day for 14 days. The clinical diagnistic was concentratedon the observation of skin appearance, fell, visible mucouses, nutrition state, mental and motor activity, reaction to the impulses and the examination of the function of aspirative,digestive, urogenital and circulatory apparatus. All the animals survived the testing period without any symptoms of intoxication.

Justification for classification or non-classification

No classification is required according to the classification criteria 67/548/EEC and regulation No. 1272/2008 (GHS, CLP)