2-(2-(2-ethoxyethoxy)ethoxy)ethanol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial Reverse Mutation data

Protocol [Klimisch rating]	Strains tested	Positive and negative controls	Maximum tested dose	Result with and without metabolic activation	Reference
Data for DEGME
OECD 471 [2]	TA 98, 100, 1535, 1537,	Yes	5mg/plate	Without: Negative With: Negative	BASF AG (1989)
Data for DEGEE
OECD 471 [1]	TA 98, 100, 102, 1535, 1537	Yes	5mg/plate	Without: Negative With: Negative (S9)	Aujoulat (1999)
Data for DEGBE
Equivalent or similar to OECD 471 [2]	TA 98, 100, 1535, 1537, 1538	Yes	20mg/plate	Without: Negative With: Negative (S9)	Thompson (1984)
Data for TEGME
Equivalent or similar to OECD 471 [1]	TA 98, 100, 1535, 1537, 1538, E coliWP2 uvrA	Yes	10mg/plate first experiment, 5mg/plate second experiment	Without: Negative With: Negative (rat S9)	Muller (1988)
Data for EGnPE
OECD 471 [1]	TA 98, 100, 1535, 1537, E coliWP2 uvrA	Yes	5mg/plate	Without: Negative With: Negative	Harlan Laboratories Ltd (2011a)

There are a further three negative studies available on TEGME and one further negative study on DEGBE and DEGME. None of these studies were used as key studies for their respective substances and are therefore not reported further here. All are completely consistent with the results presented in the table above.

Cytotoxicity data    

 

Protocol [Klimisch rating]	Species/strain	Positive and negative controls	Maximum tested dose	Result with and without metabolic activation	Reference
Data for EGnPE
OECD 473 (CA) [1]	Human Lymphocytes	Yes	1mg/mL	Without: Negative With: Negative	Harlan Laboratories Ltd (2011b)
Data for DEGBE
Equivalent or similar to OECD 473 (CA) [2]	CHO	Yes	5mg/mL	Without: Negative With: Negative (rat S9)	Thompson (1984)
Data for TEGME
OECD 473 (CA)* [1]	CHO	Yes	5mg/mL	Without: Negative With: Negative (rat S9)	Brooks (1992)

*test material a formulated brake fluid comprising 30-40% of TEGME

Mammalian cell gene mutation data

 

Protocol [Klimisch rating]	Strains tested-Target gene	Positive and negative controls	Maximum tested dose	Result with and without metabolic activation	Reference
Data for EGnPE
OECD 476 [1]	ML-L5178Y	Yes	1mg/mL	Without: Negative With: Negative	Harlan Laboratories Ltd (2011c)
Data for DEGBE
Equivalent or similar to OECD 476 [1]	CHO-HPGRT	Yes	5mg/mL	Without: Negative With: Negative (rat S9)	Dow (1987), Gollapudi (1993)
Data for TEGME
EPA OTS 798.5300 [1]	CHO-HPGRT	Yes	5mg/mL	Without: Negative With: Negative (rat S9)	Dow (1990a)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Protocol [Klimisch rating]	Species and strain used	Positive and negative controls	Maximum tested dose and exposure period	Result	Reference
Data for DEGEE
Equivalent or similar to OECD 474 (micronucleus) [2]	Mouse CD1 (male)	Yes	2mL/day for 3 days ip. Single limit dose used.	Negative	Berte (1986)
Equivalent or similar to OECD 486 (UDS) [1]	Rat Wistar (male)	Yes	2000mg/kg single limit dose po.	Negative	Clare (1996)
Data for DEGBE
Equivalent or similar to OECD 475 (CA) [2]	Mouse CD1 (male/female)	Yes	3300mg/kg single MTD dose po.	Negative	Gollapudi (1993)
Data for TEGME
EPA OTS 798.5395 (MN) [1]	Mouse CD1 (male/female)	Yes	2000mg/kg single dose po.	Negative	Dow (1990b)

There is a negative drosophilia study using DEGBE. This was not used as key studies for DEGBE and therefore not reported further here.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

The in vitro information covering the three required study end points for REACH of bacterial reverse mutation, cytogenicity in mammalian cells and mammalian cell gene mutation is consistently negative for all of the source substances. In the limited cases where there is any possible interpretation of equivocal results, in vivo data is available to provide re-assurance that all of the source substances are negative for mutagenic potential. The shared structural elements and common metabolic pathways across the source and target substances provides confidence in the reliability of using read across data for fulfilling the requirements for this end point for TEGEE and the data leads to the conclusion there is no evidence that TEGEE will have any mutagenic potential. Classification for this end point is not required.