Reaction products of long-chain fatty alcohols and inorganic acid with 2-aminoalkanol

Endpoint summary

Description of key information

NOAEL rat subacute = 300 mg/Kg bw

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

300 mg/kg bw/day

Study duration:

subacute

Species:

rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The toxic potential of the substance after repeated dose is evaluated by considering data on Similar Substances. Justification for Read Across is given in Section 13 of IUCLID.

Treatment with the test material by oral gavage in male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg revealed parental toxicity for males at 1000 mg/kg.

Based on these results, the following No Observed Adverse Effect Levels (NOAEL) were derived: Parental NOAEL: 300 mg/kg for males, and at least 1000 mg/kg for females

Read across from similar substances indicate that no effects were seen at the highest concentration tested, therefore the 'No Observed Adverse Effect Level' (NOAEL) for systemic toxicity and reproductive toxicity was considered to be 1000 mg/kg/day. There were no treatment related effects or abnormalities observed. The oral route was considered the most relevant for these substances. Dermal and inhalation studies were not conducted.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008 substances are classified as specific target organ toxicants following repeated exposure by the use of expert judgement, on the basis of the weight of all evidence available, including the use of recommended guidance values which take into account the duration of exposure and the dose/concentration which produced the effect(s), and are placed in one of two categories, depending upon the nature and severity of the effect(s) observed:

Category 1: substances that have produced significant toxicity in humans or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following repeated exposure. Substances are classified in Category 1 for target organ toxicity (repeat exposure) on the basis of: reliable and good quality evidence from human cases or epidemiological studies; or observations from appropriate studies in experimental animals in which significant and/or severe toxic effects, of relevance to human health, were produced at generally low exposure concentrations. Guidance dose/concentration values are provided in 3.9.2.9, to be used as part of a weight-of- evidence evaluation.

Category 2: substances that, on the basis of evidence from studies in experimental animals can be presumed to have the potential to be harmful to human health following repeated exposure. Substances are classified in category 2 for target organ toxicity (repeat exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations.

To evaluate whether the substance should be classified or not for specific target organ toxicity-repeated exposure, the available data from sub-acute studies on similar substances are used. As a conservative approach the lowest NOAEL obtained in the studies is considered and therefore a LOAEL of 1000 mg/kg bw/day is adopted. This LOAEL allows the non-classification of the substance since significant toxic effects observed in the repeated-dose study occurs above the guidance value ranges. Consequently the substance is not classified as a STOT-RE according to the criteria set out in the CLP Regulation (EC) No.1272/2008.