Paraffin waxes and Hydrocarbon waxes, chloro

Endpoint summary

Description of key information

There is adequate data to assess the acute toxicity of LCCPs. C20-30 LCCPs (both solid and liquid) have no observed acute toxicity at top doses in the range of 5.0  to 23 g/kg bwt in several species. It is anticipated that C18-20 liquid grade LCCPs are of very low acute toxicity based on read-across to MCCPs, which have an oral LD50 >2.0 g/kg bwt in the rat.

There are no data on the acute toxicity of LCCPs following dermal administration. However, as it is anticipated that they would not be absorbed to any significant extent via this route, it is considered unnecessary to conduct such tests. Similarly, there are no data on the acute toxicity of LCCPs following inhalation, although the physico-chemical properties and the pattern of use very low vapour pressure of LCCPs make this an unlikely route of exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Valid studies in the rat, mouse, and dog have been reported on both liquid and solid LCCPs in the C_20-30range. The most consistent observation made during the post-exposure period was evidence of faecal incontinence, presumably associated with the large volume of test material administered. No mortalities were observed and all studies reported LD₅₀values > 5.0 g/kg bwt.

No valid studies have been conducted on a C_18-20liquid grade LCCP. However, the fact that C_14-17CPs also have high LD₅₀values (i.e. > 2.0 g/kg bwt) suggests that this type of LCCP would have a similar low acute toxicity (UK Environment Agency, 2009).

Justification for classification or non-classification

LCCPs demonstrate a low order of acute toxicity. No mortalities were observed and the reported oral LD₅₀values all exceeded 5,000 mg/kg bwt in the rat, mouse and dog. This conclusion is also supported by additional acute intraperitoneal (i.p.) studies in rats and mice that showed no mortality at 5,000 mg/kg bwt (i.p.) with several different LCCP test substances. The lack of acute toxicology data via inhalation or dermal exposure routes for LCCPs is not expected to be an important data gap as these routes of exposure are insignificant for LCCPs, which have very low vapour pressure and are absorbed very poorly through the skin.