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Carcinogenicity

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Description of key information

There are conclusive but not suffcient data for the classification of substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol with regard to carcinogenicity

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
209 mg/kg bw/day

Carcinogenicity: via inhalation route

Endpoint conclusion
Dose descriptor:
NOAEC
1 054.3 mg/m³

Carcinogenicity: via dermal route

Endpoint conclusion
Dose descriptor:
NOAEL
5.3 mg/kg bw/day

Additional information

Oral

Correcting for molecular weight, a conservative NOAEC (oral) of 209 mg/kg bw/day can be derived.

(120 x 206.28) / 118.2=209 mg/kg bw/day

Inhalation

Correcting for molecular weight, a conservative NOAEC (inhalation) of 1054.3 mg/m3 can be derived.

(604.14 x 206.28) / 118.2=1054.3 mg/m3

Dermal Effects:

For dermal exposure we taken that:

-the average weight of rats is 250g (200-300g),

-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg

 

corrected dermal NOAEL=   oral NOAEL

                                  209mg/kg bw/day0.025 kg =                  

 NOAELrat   = 5.3 mg/kg bw/day

 



Carcinogenicity: via oral route (target organ): digestive: liver; digestive: stomach; other: all gross lesions and masses

Carcinogenicity: via inhalation route (target organ): digestive: liver; digestive: stomach; other: all gross lesions and masses

Carcinogenicity: via dermal route (target organ): other: skin

Justification for classification or non-classification

Based on the hazard assessment of2-(2-(2-butoxyethoxy)ethoxy)ethanolin section 2.1 and 2.2. in IUCLID 5.3., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” and according to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Carcinogenicity

Carc. Cat. 1; R45 May cause cancer.

Carc. Cat. 1; R49 May cause cancer by inhalation.

Carc. Cat. 2; R45 May cause cancer.

Carc. Cat. 2; R49 May cause cancer by inhalation.

Carc. Cat. 3; R40 Limited evidence of a carcinogenic effect.

 

CLP

Carcinogenicity

Carc. 1A

Carc. 1B

Carc. 2

H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.

It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanol does not meet the criteria to be classified for human health hazards for Carcinogenicity.