Tetradecan-1-ol, propoxylated, esters with propionic acid

Endpoint summary

Description of key information

Based on the information available it can be concluded that the substance is not hazardous following short-term expsoure via the dermal route and the substance has a NOAEL of 1,000 mg/kg bw/day.

An experiment for short-term repeated dose (28-day) oral toxicity has been waived as the dermal route is considered to be the most relevant route of administration for PPG-2 myristyl ether propionate and sufficient information is available to determine dermal toxicity following repeated dose. Equally, as the substance has a low vapour pressure and, therefore, volatility, it is not expected that human exposure via inhalation during use / production will occur. A short-term repeated dose (28-day) toxicity test for inhalation has subsequently been waived.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study by the oral route does not need to be conducted because an appropriate dermal study is available and dermal is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

other: Endpoint Assessment Report: Short-term Repeated-dose Toxicity via the Dermal Route

Adequacy of study:

key study

Study period:

March 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

no guideline required

Principles of method if other than guideline:

An extensive literature search was undertaken to identify studies on the toxicity of PPG-2 myristyl ether propionate following a repeated exposure via the dermal route.

GLP compliance:

no

Key result

Remarks on result:

other: Quantative results not determined

Key result

Critical effects observed:

no

Conclusions:

Based on the information available it can be concluded that the substance is not hazardous following short-term expsoure via the dermal route and has a NOAEL of 1,000 mg/kg bw/day.

Executive summary:

A reliable study performed by Bernard et al. (1998) was identified in the literature. This study included examination of the reproductive organs of treated animals allowing to investigate the effects of the substance to fertility. It is concluded that PPG-2 myristyl ether propionate is not hazardous following a short-term exposure via the dermal route and has a NOAEL of 1,000 mg/kg bw/d. This is supported by the historical uses of the substance is cosmetics and personal care products.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Species:

rat

Repeated dose toxicity: dermal - local effects

Link to relevant study records

Reference

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

other: Endpoint Assessment Report: Short-term Repeated-dose Toxicity via the Dermal Route

Adequacy of study:

key study

Study period:

March 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

no guideline required

Principles of method if other than guideline:

An extensive literature search was undertaken to identify studies on the toxicity of PPG-2 myristyl ether propionate following a repeated exposure via the dermal route.

GLP compliance:

no

Key result

Remarks on result:

other: Quantative results not determined

Key result

Critical effects observed:

no

Conclusions:

Based on the information available it can be concluded that the substance is not hazardous following short-term expsoure via the dermal route and has a NOAEL of 1,000 mg/kg bw/day.

Executive summary:

A reliable study performed by Bernard et al. (1998) was identified in the literature. This study included examination of the reproductive organs of treated animals allowing to investigate the effects of the substance to fertility. It is concluded that PPG-2 myristyl ether propionate is not hazardous following a short-term exposure via the dermal route and has a NOAEL of 1,000 mg/kg bw/d. This is supported by the historical uses of the substance is cosmetics and personal care products.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/cm²

Species:

rat