Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
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.

Data source

Reference
Reference Type:
other: Expert assessment
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-butoxyethyl methacrylate
EC Number:
236-885-7
EC Name:
2-butoxyethyl methacrylate
Cas Number:
13532-94-0
Molecular formula:
C10H18O3
IUPAC Name:
2-butoxyethyl 2-methylprop-2-enoate

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:
other: An assessment was performed based on available information and uses of the substance. According to section 8.7.1. of REACH, testing for screening for toxicity to the reproduction does not need to be conducted if relevant human exposure can be excluded.

Target system / organ toxicity (P0)

Critical effects observed:
no

Results: F1 generation

Effect levels (F1)

Remarks on result:
other: An assessment was performed based on available information and uses of the substance. According to section 8.7.1. of REACH, testing for screening for toxicity to the reproduction does not need to be conducted if relevant human exposure can be excluded.

Target system / organ toxicity (F1)

Critical effects observed:
no

Overall reproductive toxicity

Reproductive effects observed:
no

Applicant's summary and conclusion

Conclusions:
According to section 8.7.1. of Annex VIII of the REACH regulation ((EC) No 1907/2006), testing for screening for toxicity to reproduction 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 screening for toxicity to reproduction 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 8.7.1. of Annex VIII of the REACH regulation ((EC) No 1907/2006), testing for screening for toxicity to reproduction 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 screening for toxicity to reproduction study based on exposure to the substance was appropriate. Further testing is therefore considered not required.