Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: dermal
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.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
EC Number:
205-592-6
EC Name:
2-(2-(2-butoxyethoxy)ethoxy)ethanol
Cas Number:
143-22-6
Molecular formula:
CH3(CH2)3(OCH2CH2)3OH
IUPAC Name:
2-[2-(2-butoxyethoxy)ethoxy]ethanol
Constituent 2
Chemical structure
Reference substance name:
3,6,9,12-tetraoxahexadecan-1-ol
EC Number:
216-322-1
EC Name:
3,6,9,12-tetraoxahexadecan-1-ol
Cas Number:
1559-34-8
Molecular formula:
C12H26O5
IUPAC Name:
3,6,9,12-tetraoxahexadecan-1-ol

Results and discussion

Effect levels

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Dose descriptor:
NOAEL
Effect level:
5 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: All other effects other than local irritation
Remarks on result:
other: based on a weighted average consideration of the results for this substance based on other substances within the category. Results corrected for molecular weight differences.
Remarks:
There is no data on the repeat dose toxicity of this substance from studies to modern guidelines. A sub-acute bridging study is being carried out on this substance to add confidence to bridging between members of this category
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
dermal irritation
Remarks on result:
other: based on a weighted average consideration of the results for this substance based on other substances within the category. Results corrected for molecular weight differences.
Remarks:
There is no data on the repeat dose toxicity of this substance from studies to modern guidelines. A sub-acute bridging study is being carried out on this substance to add confidence to bridging between members of this category

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion