Alcohols, C11-15-secondary, ethoxylated

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

A weight of evidence (Waiver for the extended one generation reproductive toxicity study, 2017) has been prepared to demonstrate that softanol 30 and alcohol ethoxylates (AEs) have no effects on fertility.

This weight of evidence is based on information from studies available with softanol 30 as well as studies available from other alcohol ethoxylates. Alcohol ethoxylates are evaluated as a single chemical category in the HERA human health risk assessment (2009) based on structural similarities, similar toxicokinetics and similar toxicological profile.

The studies described in this dossier and the studies described in the HERA document show that their acute toxicity is low by the oral and dermal routes, softanol 30 seems to be less irritating to skin and eyes and they are of low genotoxcity. Effects from repeated doses to rats are confined to lesions in the forestomach of rats which are a consequence of the irritancy of the surfactant test substance and hypertrophy of the hepatic cells which are due to hepatic enzyme induction, adaptative changes accompanying chemical-induced metabolic activation of the liver. In softanol these effects are alos accompanied by hyaline droplet nephropathy which is not relevant to human and hypertrophy of follicular cells in the thyroid which is a secondary effect of liver enzyme induction. No effects on reproductive organs were observed in any of the repeated dose studies with softanol and other AEs. Finally, the AEs were found to have an effect on bodyweights of females and pups in two-generations studies but no effects on reproductive toxicity or teratogenicity at doses that were not toxic to females rats or rabbits.

Human & risk assessment on ingredients of European household cleaning products. Alcohol Ethoxylates. Version 2.0, September 2009

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Effects on developmental toxicity

Description of key information

In a rat developmental toxicity study at 0, 100, 300 or 1000 mg/kg/day, body weight and food consumption were low in dams at 1000 mg/kg/day, and body weight of fetuses was also low at the same dose level; therefore, the No-observed-adverse-effect level (NOAEL) was considered to be 300 mg/kg/day in both dams and fetuses. It was also concluded that the test article induces no teratogenicity up to the dose level of 1000 mg/kg/day. Softanol 30 does not meet the criteria for classification as a developmental toxicant.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

300 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

Developmental toxicity has been investigated in a non- GLP compliant preliminary study and a fully GLP compliant OECD 414 developmental toxicity study..

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Justification for classification or non-classification

Softanol 30 does not meet the criteria for classification as a developmental toxicant since in a fully GLP-compliant OECD 414 study, the adverse effects observed in fetuses were confined to low fetal body weights and only observed in the presence of maternal toxicity at 1000 mg/kg bw/day. There was no evidence of any teratogenic effects. Therefore Softanol 30 should not be classified as a developmental toxicant under the CLP regulation.