2-butoxyethyl methacrylate

Endpoint summary

Description of key information

An assessment in accordance with REACH regulation ((EC) No 1907/2006) was performed to consider the prospect to apply Annex XI adaption rules based on exposure to 2-butoxyethylmethacrylate. According to section 8.6.1. of Annex VIII of the REACH regulation ((EC) No 1907/2006), testing for short-term repeated-dose toxicity does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI Section 3. It was concluded that the use of Annex XI to waive the short-term repeated dose toxicity study based on exposure to the substance was appropriate. Further testing is therefore considered not required.

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

Type of information:

other: Expert Assessment

Adequacy of study:

key study

Study period:

27/11/2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An assessment was performed to investigate the possibility to apply Annex XI adaptation rules based on exposure to the substance.

Qualifier:

no guideline required

Principles of method if other than guideline:

An assessment was performed to investigate the possibility to apply Annex XI adaptation rules based on exposure to the substance.

GLP compliance:

no

Limit test:

no

Key result

Remarks on result:

other: An assessment was performed based on available information and uses of the substance. According to section 8.6.1.of REACH, testing for short-term repeated-dose toxicity does not need to be conducted if relevant human exposure can be excluded.

Critical effects observed:

no

Conclusions:

According to section 8.6.1.of Annex VIII of the REACH regulation ((EC) No 1907/2006), testing for short-term repeated-dose toxicity does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI Section 3. It was concluded that the use of Annex XI to waive the short-term repeated dose toxicity study based on exposure to the substance was appropriate.

Executive summary:

An assessment in accordance with REACH regulation ((EC) No 1907/2006) was performed to consider the prospect to apply Annex XI adaption rules based on exposure to 2-butoxyethylmethacrylate. According to section 8.6.1. of Annex VIII of the REACH regulation ((EC) No 1907/2006), testing for short-term repeated-dose toxicity does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI Section 3. It was concluded that the use of Annex XI to waive the short-term repeated dose toxicity study based on exposure to the substance was appropriate. Further testing is therefore considered not required.

Endpoint conclusion

Endpoint conclusion:

no study available

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

Justification for classification or non-classification

According to section 8.6.1. of Annex VIII of the REACH regulation ((EC) No 1907/2006), testing for short-term repeated-dose toxicity does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI Section 3. It was concluded that the use of Annex XI to waive the short-term repeated dose toxicity study based on exposure to the substance was appropriate. Further testing is therefore considered not required.