2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol

Endpoint summary

Description of key information

LD50 (Oral gavage, rat) > 15000 mg/kg bw.
LD50 (Dermal, 6 hours, guinea pig) > 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

15 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

An acute oral toxicity study (Bozo Research Centre Inc., 1991) was conducted in rats. Ten male and ten female rats received a single dose (15000 mg/kg bodyweight) by gavage, then were observed for mortality and clinical signs for 14 days. No animals died, and there were no abnormal findings at necropsy.

An acute dermal toxicity study was conducted (Batelle Institut E.V., Frankfurt) in Albino guinea pigs according to OECD test guideline 402. Five males and five females were dosed at 2000 mg/kg with the test material in olive oil vehicle; the test material was applied and the test site secured with an occlusive dressing for 6 hours. No animals died, and no signs of local or systemic toxicity were observed.

Justification for classification or non-classification

The LD50 for both oral and dermal exposure were determined to be greater than 2000 mg/kg for acute exposure; on this basis NC-4 does not trigger the criteria for classification as acutely toxic, according to EC Regulation 1272 /2008.

In both the oral and dermal tests, animals were dosed at or above the limit dose, and no signs of local or systemic toxicity were observed. As no abormalities were seen in the necropsy phase of either study, it may be concluded that neither of these exposure routes display Specific Target Organ Toxicity (STOT Acute) and so classification for this hazard should not be applied. As there is no data concerning STOT following inhaled exposure to NC-4, the overall classification regarding STOT Acute is inconclusive.