Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] hydrogen glutarate

Endpoint summary

Description of key information

The test substance is a liquid with a very low vapour pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols or inhalable droplets, so exposure to humans via the inhalatory route will be unlikely to occur. Results of laboratory animal studies performed with category members show moderate oral toxicity and no dermal toxicity. Effects observed in subchronic oral studies were reduced body weight gain, hepatic hypertrophy and increased peroxisomal enzyme activity.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Reference 1

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Justification for type of information:

Adipic acid diesters category. See attached report.

Key result

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day (nominal)

Basis for effect level:

other: not specified

Critical effects observed:

not specified

Conclusions:

According to the category read-across approach, the lowest NOAEL from a 28-day oral repeated dose toxicy study with rats (OECD TG 407) available among category members is 100 mg/kg bw/day.

Reference 2

Endpoint:

sub-chronic toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Justification for type of information:

Adipic acid diesters category. See attached report.

Key result

Dose descriptor:

NOAEL

Effect level:

189 mg/kg bw/day (nominal)

Basis for effect level:

body weight and weight gain

other: reduced body weight gain, hepatic hypertrophy and increased peroxisomal enzyme activity

Key result

Critical effects observed:

yes

Lowest effective dose / conc.:

3 100 ppm

System:

hepatobiliary

Organ:

liver

Treatment related:

yes

Dose response relationship:

not specified

Relevant for humans:

not specified

Conclusions:

According to the category read-across approach, the lowest NOAEL from a 90-day oral repeated dose toxicy study with rats available among category members is 189 mg/kg bw/day.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

189 mg/kg bw/day

Study duration:

subchronic

Species:

rat

System:

hepatobiliary

Organ:

liver

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

Link to relevant study records

Reference

Endpoint:

sub-chronic toxicity: dermal

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Justification for type of information:

Adipic acid diesters category. See attached report.

Key result

Dose descriptor:

NOAEL

Effect level:

> 2 000 mg/kg bw/day

Remarks on result:

not determinable due to adverse toxic effects at highest dose / concentration tested

Key result

Critical effects observed:

no

Conclusions:

According to the category read-across approach, no effects were observed in dermal repeated dose toxicy studies available among category members.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Basing on the available repeated toxicity data, bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] hydrogen glutarate is not classified for specific target organ toxicity after repeated exposure, according to Regulation (EC) n. 1272/2008.