Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction

Endpoint summary

Description of key information

Experimental studies on oral and dermal acute toxicity are available. Corfree has very low toxicity upon acute exposure.
Oral: LD50 (males/female rats):  > 5,000 mg/kg bw 
Dermal: LD50 (males/ rabbits):  > 6,000 mg/kg bw
Inhalation:LC50 (male rats/4h) :  No data

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

6 000 mg/kg bw

Additional information

Corfree M1 has very low toxicity by the oral or dermal route. A dermal LD₅₀greater than 6,000 mg/kg was reported for the the major chemical (dodecanedioic acid) in Corfree. An oral LD₅₀greater than 5000 mg/kg was reported for Corfree M1. No data on acute toxicity upon inhalation are available. However, since the vapour pressure of dodecanedioic acid, the read across chemical, is very low (1.5 x 10E-8 Pa) exposure via the inhalation route is predicted to be not relevant and a study on inhalation toxicity can be waived. Also, Corfree® M1 (> 95%) is composed of large particles (400-2000um diameter) and inhalation is not expected to be an issue.

Justification for selection of acute toxicity – inhalation endpoint
The potential for inhalation exposures to Corfree® M1 during production is expected to be negligible, particularly up to the time that the product is dehydrated, flaked, and dropped into a hopper car loading bin. Corfree® M1 (> 95%) is composed of large particles (400-2000um diameter) with only <0.5% of the substance in the inhalable range (<100um). Inhalation is not a significant route of exposure for these large size particle substances.

Justification for classification or non-classification

Corfree® M1 (CASRN: 72162-23-2) based on the results of oral ( LD50 males/female rats > 5,000 mg/kg bw) and dermal (LD50 males/ rabbits > 2,000 mg/kg bw) has very low toxicity. Inhalation is not relevant because of low vapour pressure. Therefore, classification regarding acute toxicity is not warranted.