2-(4-amino-2-nitroanilino)ethanol

Endpoint summary

Description of key information

According to the result of the key study (Sterner, 1983, Klimisch 2, method comparable to OECD 401 ; Burnett, 1987, Klimisch 2, method comparable to OECD 401), the results of the test indicated that the lethal oral dose (LD5O) was 3940 mg/kg in males and 2950 mg/kg in females, for males and females the LD50 value was 3400 mg/kg for the first study. In the second study, the LD50 value was determined to be between 2500mg/kg and 5000 mg/kg. Hence, the test item HC Red 3 was not classififed as Acute Oral Hazard according to CLP regulation and was classified as Category 5 according to GHS regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 400 mg/kg bw

Additional information

In order to assess the potential acute toxicity by oral route of the test item, two key studies were availables :

An Acute Oral Toxicity Study was performed (Sterner, 1983, OECD 405 equivalent method).

Male and females Wistar rats of the BOR: WISW strain were administered HC Red n° 3 at the doses of 1, 2.5, 3.5 and 5 g/kg bw by oral intubation (5 males and 5 females per dose). During the observation period of 14 days, a record was kept for mortalities and signs of toxicity. Body weights were recorded on day 0 and day 14 for the surviving animals. All rats that died were investigated macroscopically to identify organ changes in the skull, thorax and abdomen and surviving animals were similarly examined at the end of the 14-day post-observation.

At the dose of 5 g/kg bw, 9 of 10 rats died within 24h. At the dose of 3.5 g/kg bw, 4 of 10 rats died within 24h and a total of 6 after 48h. 1 of 10 rats died within 24h at the dose of 2.5 g/kg bw. No mortalities were observed at 1g/kg. Red-blue colorations of mucosae and urine were observed in all rats. At the tested doses, reduced activity was observed during the first 30 minutes and continued in the surviving

rats up to 72h. After that and during the rest of the observation period, these animals had normal appearance.

Male and females Sprague-Dawley Rats, in the weight range 190 to 240 g were treated via oral gavage with HC Red n° 3 in a 10 % suspension in 3% acacia in water at the doses of 1250 and 5000 mg/kg bw for male rats and 1250, 2500 and 5000 mg/kg for female rat.(Burnett, 1987, Klimisch 2, method comparable to OECD 401). A nimals were observed during 14 days after treatment.In male rats, no death was observed at the dose of 1250 mg/kg bw and 5/5 deaths at the dose of 5000 mg/kg bw. In female rats, no death was observed at the dose of 1250 mg/kg bw, 1/5 death at the dose of 2500 mg/kg bw and 5/5 deaths at the dose of 5000 mg/kg bw. The results of this study indicated that the median lethal oral dose (LD5O), was in the region of 1250 to 5000 mg/kg bw in the male rats and in the region of 2500 and 5000 mg/kg bw in females. Signs of reaction to treatment were not recorded. Under the experimental conditions of this study, the results indicated that the median lethal oral dose (LD5O), was in the region of 1250 to 5000 mg/kg bw in the male rats and in the region of 2500 and 5000 mg/kg bw in females. According to this results and previous study performed, females had more sensibility to acute effect of the test substance. Hence, the median LD50 value of the females could be attributed to male rats too, the test item was not classiffied for Acute Oral Hazard according to CLP criteria.

Justification for classification or non-classification

According to the result of the key study(Sterner, 1983, Klimisch 2, method comparable to OECD 401 ; Burnett, 1987, Klimisch 2, method comparable to OECD 401), the results of the test indicated that the lethal oral dose (LD5O) was 3940 mg/kg in males and 2950 mg/kg in females, for males and females the LD50 value was 3400 mg/kg for the first study. In the second study, the LD50 value was determined to be between 2500mg/kg and 5000 mg/kg. Hence, the test item HC Red 3 was not classififed as Acute Oral Hazard according to CLP regulation and was classified as Category 5 according to GHS regulation.