Registration Dossier

Administrative data

Description of key information

ORAL ROUTE (all rat)

- NOAEL rat (for surrogate): 250mg/kg, LOAEL 1000mg/kg (90 day drinking water study). Molar equivalency is 315mg/kg and 1260mg/kg respectively.

DERMAL

- NOAEL rat (for surrogate): 2000ml/kg (13 week occlusive study)  equivalent to 2400mg/kg (rounded to 2 sig fig.)  max dose tested

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
315 mg/kg bw/day
Study duration:
subchronic
Species:
rat

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 adverse effect observed
Dose descriptor:
NOAEL
2 400 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The key study for the oral route is a recent 90 day sub-chronic guideline and GLP drinking water study in rats. Multiple, albeit mild, effects were seen at 1000mg/kg. At 250mg/kg, the only treatment related effects were equivocal changes in erythron that were statistically significant to unusually high concurrent controls but within historical control ranges. This dose level was therefore considered to be the no adverse effect level. This is equivalent on a molar basis to a NOAEL of 315mg/kg/day for DEGBEA.

The key study by the dermal route was one designed to assess the sub-chronic and reproductive toxicity of 2 -(2 -butoxyethoxy)ethanol to rats by the dermal route. The only effect of note was dermal irritation at the site of repeated application which occured at all doses, albeit very slight at the low dose and only in males towards the end of the study. There were no adverse systemic toxicity findings noted and the NOAEL was set at 2000mg/kg. This is equivalent on a molar basis to a NOAEL of 2400mg/kg/day for DEGBEA, when rounded to 2 significant figures. Note that the local effects cannot be extrapolated to DEGBEA since metabolism would not have occured at this stage.

There is no study available by the inhalation route. No study is required due to the low vapour pressure and the resultant low hazard by this route.


Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other

Justification for classification or non-classification

Based on the results from a closely related surrogate substance and therefore a reliable extrapolation, no adverse effects would be expected at the repeat dose levels associated with classification.