Hexadecyl acetate

Endpoint summary

Description of key information

The test item is a waxy solid that is used in the neat state exclusively as a cosmetic ingredient under industrial conditions. No evidence of systemic toxicity or local effects has been reported in acute studies and long-term investigations involving vertebrate animals are not appropriate.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

repeated dose toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Critical effects observed:

not specified

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

 

The pure test item is used exclusively as a cosmetic ingredient and is handled at industrial sites where stringent risk mitigation measures are in place and oral exposure is not expected under normal operational conditions. As a result,and in line with the ECHA news alert ‘Clarity on interface between REACH and the Cosmetics Regulation’ of 27 October 2014, where registrants are permitted to perform animal testing to meet the human health information requirements of REACH only when there is a need to assess worker safety, investigation of repeated dose oral toxicity in vertebrate animals is contraindicated.

 

Inhalation

 

The test item is a waxy solid with a vapour pressure of 4.8E-03 Pa at 25°C, is used in the neat state exclusively as a cosmetic ingredient, and is handled at industrial sites where stringent risk mitigation measures are put in place as a matter of course. No evidence of corrosion/irritation or sensitisation has been reported. Based on evaluation of the life cycle of the substance it is concluded that inhalation exposure will be low and that the most likely route of exposure for workers will be the dermal route. As a result, and in line with the ECHA news alert ‘Clarity on interface between REACH and the Cosmetics Regulation’ of 27 October 2014, where registrants are permitted to perform animal testing to meet the human health information requirements of REACH only when there is a need to assess worker safety, investigation of repeated dose toxicity via the inhalation route is inappropriate.

 

Dermal

 

The neat test item is used exclusively as a cosmetic ingredient and, in the light of that fact, dermal administration would normally constitute the most appropriate route for testing in the absence of existing data. However, no evidence of systemic toxicity was noted when acute results for the test item were evaluated by the Cosmetic Ingredient Review Expert Panel (see Section 7.2.3) and the test material was applied to human subjects multiple times over an extended period without eliciting visible responses (0.1mL*density/body weight = 0.1ml*962mg/mL/70kg =1.37mg/kg). Further evidence that worker safety should not be considered a concern arises from the fact that the test item is handled at industrial sites where stringent risk mitigation measures are routinely incorporated into operational procedures. As a result, and in line with the ECHA news alert ‘Clarity on interface between REACH and the Cosmetics Regulation’ of 27 October 2014, where registrants are permitted to perform animal testing to meet the human health information requirements of REACH only when there is a need to assess worker safety, it is considered inappropriate to carry out further investigations involving vertebrate animals. 

Justification for classification or non-classification

No evidence of systemic toxicity or local effects has been reported in acute studies, exposure of humans via the inhalation route is unlikely due to the physico-chemical properties of the substance, and long-term investigations involving vertebrate animals are not appropriate for a cosmetic ingredient that is used in the neat state only in an industrial setting. Supporting evidence for lack of systemic and local effects is available from a study in which dermal application of 50 % test material in petrolatum (equivalent to 45 % of the test item described in this dossier) did not elicit any response in 50 out of 53 human volunteers when applied to the same test site for 24 hours on four consecutive days for a period of three weeks. Classification under the terms of Regulation (EC) No 1272/2008 is therefore not required.