Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

For justification of read across see category justification attached to category object.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study planned (based on read-across)

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS.

****PLEASE NOTE THAT THIS TESTING PROPOSAL HAS ALREADY BEEN SUBMITTED IN THE REGISTRATION DOSSIER FOR THE SUBSTANCE
2-92-92-butoxyethoxy)ethoxy)ethanol (CAS143-22-6, EC 205-592-6)*****

NON-CONFIDENTIAL NAME OF SUBSTANCE:
Proposed test substance: - 2-(2-(2-butoxyethoxy)ethoxy)ethanol
- This study will also be used through direct read across to support the following substances:
• Ethanol, 2-butoxy-, manufacture of, by-products from (EC: 310-287-7, CAS: 161907-77-3) (Substance not currently active)
• Poly(oxy-1,2-ethanediyl), α-butyl- ω-hydroxy (EC: 500-012-2, CAS: 9004-77-7)
• Reaction mass of 2-(2-(2-butoxyethoxy)ethoxy)ethanol and 3,6,9,12-tetraoxahexadecan-1-ol
• 3,6,9,12-tetraoxahexadecan-1-ol (EC 216-322-1)1559-34-8)


CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: None
- Available non-GLP studies: Chernoff-Kavlock screening study
- Historical human data: None
- (Q)SAR: None identified of sufficient reliability
- In vitro methods: Zebrafish Embryotoxicity (ZET) study carried out. Positive findings with a key metabolite of the proposed test substance
- Weight of evidence: Insufficient data available on test substance
- Grouping and read-across: Proposed approach is to group similar glycol ethers into a category. It was expected that a new screening study would be sufficient to justify read across to this substance from another similar substance that has a full PNDT study available, however the results of the ZET study indicate that a full study on this substance is now required. The results of this study will be used to support other substances and, depending on the results, will be used to support a wider number of substances through read across.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable.
- Other reasons [if applicable]

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- These have been considered but are not considered adequate in the light of current data now available.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: No additional information.

Reason / purpose for cross-reference:

other: Information to support testing proposal

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Version / remarks:

Oral gavage route of exposure.

Species:

rat

Route of administration:

oral: gavage

Cross-reference 2

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Remarks:

To be carried sequentially after completion of proposed PNDT study in rats.

Justification for type of information:

TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- 2-(2-(2-butoxyethoxy)ethoxy)ethanol
- This study will also be used through direct read across to support the following substances:
• Poly(oxy-1,2-ethanediyl), α-butyl- ω-hydroxy (EC: 500-012-2, CAS: 9004-77-7)
• Reaction mass of 2-(2-(2-butoxyethoxy)ethoxy)ethanol and 3,6,9,12-tetraoxahexadecan-1-ol


CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: None.
- Available non-GLP studies: Chernoff-Kavlock screening study
- Historical human data: None
- (Q)SAR: None identified of sufficient reliability
- In vitro methods: Zebrafish Embryotoxicity (ZET) study carried out. Positive findings with a key metabolite of the proposed test substance
- Weight of evidence: Insufficient data available on test substance
- Grouping and read-across: Proposed approach is to group similar glycol ethers into a category. It was expected that a new screening study would be sufficient to justify read across to this substance from another similar substance that has a full PNDT study available, however the results of the ZET study indicate that a full PNDT data set on this substance is now required. The results of this study will be used to support other substances and, depending on the results, will be used to support a wider number of substances through read across.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable.
- Other reasons [if applicable]

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- These have been considered but are not considered adequate in the light of current data now available.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: A test proposal for a rat PNDT study is submitted and has been subject to public consultation. The outcome of this will be used as a basis to decide whether a rabbit study is necessary. Should the rat study show effects that warrant classification as category 1B then the rabbit study will not be carried out. In any other case, the rabbit study will be required. This test woulld therefore be unlikely to start until 2022 at the earliest.

Reason / purpose for cross-reference:

other: Information to support testing proposal

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Version / remarks:

Oral gavage route of exposure.

Species:

rabbit

Route of administration:

oral: gavage

Materials and methods

Test material

Test material information

1

Reference substance name:

Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-

EC Number:

500-012-0

EC Name:

Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-

Cas Number:

9004-77-7

Molecular formula:

(C2H4O)nC4H10O

IUPAC Name:

2-butoxyethan-1-ol

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

No effects expected up to limit dose of 1000mg/kgbw/day

Maternal abnormalities

Abnormalities:

no effects observed

Results (fetuses)

Effect levels (fetuses)

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

No effects expected up to limit dose of 1000mg/kgbw/day

Fetal abnormalities

Abnormalities:

no effects observed

Overall developmental toxicity

Developmental effects observed:

no

Any other information on results incl. tables

Current available data from category members suggests no adverse effects would be seen up to the limit dose shown.

There is no data on the toxicity to development for this substance. A testing proposal has been submitted for the substance 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol or this substance and the results will be read across from one to the other using a category approach.