Indeno[4,3a-b]furan, decahydro-2,2,7,7,8,9,9-heptamethyl-

Endpoint summary

Description of key information

- Oral LD50: >2500 mg/kg bw (OECD TG 423, GLP).
- Inhalation LD50: > 6500 mg/m3 (route-to-route extrapolation from acute oral toxicity study).
- Dermal LD50: >2000 mg/kg bw (OECD TG 402, GLP).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 500 mg/kg bw

Quality of whole database:

The one study available is adequate for covering this endpoint.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Quality of whole database:

The one study available is adequate for covering this endpoint.

Additional information

Acute Oral Toxicity:

In an acute oral toxicity study which was performed in accordance with the Acute Toxic Class method (OECD TG 423) and under GLP conditions, a group of three fasted female Sprague-Dawley CD strain rats were treated with the test substance at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females at the same dose level. The test substance was administered orally undiluted. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. No mortality was observed. All animals showed expected body weight gains over the study period. There were no signs of systemic toxicity and no abnormalities were noted at necropsy. The acute oral median lethal dose (LD₅₀) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bw, based on Annex 2d of OECD TG 423.

Acute Inhalation Toxicity:

Using route to route extrapolation the inhalation toxicity can be derived as follows: an oral LD50 of 2500 mg/kg bw can be roughly converted into > 13000 mg/m3 (ECHA's CLP guidance, section, 3.1.3.3.5, 2017, using the formula: 1 mg/kg bw = 0.0052 mg/L/4h). In the present case 50/100% oral and inhalation absorption is used, which then results in an acute inhalation toxicity concentration of 6500 mg/m3. The maximum saturated vapour pressure for the substance is 41.3 mg/m3. This means that the substance cannot reach a concentration higher than 41.3 mg/m3. Therefore, an LC50 for inhalation vapour cannot be reached and no classification and labelling is needed for the acute inhalation route.

Acute Dermal Toxicity:

To assess the acute dermal toxicity of the test substance, an acute dermal toxicity study was performed in accordance with OECD TG 402 and under GLP conditions. A group of ten Sprague-Dawley CD rats (five males and five females) was given a single, 24-hour, semi-occluded dermal application of undiluted test substance to intact skin at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. No mortality was observed. There were no signs of systemic toxicity and no dermal irritation was observed. All animals showed expected gains in body weight over the study period and no abnormalities were noted at necropsy. The acute dermal median lethal dose (LD₅₀) of the test material In the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

The substance does not have to be classified for acute toxicity according to EU CLP (EC No. 1272/2008 and its amendments).