Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: study report
Title:
European Union Risk Assessment Report : ETHYL ACETOACETATE
Author:
EU Report
Year:
2002
Bibliographic source:
European Union risk assessment report (Ethyl acetoacetate) Vol:13 (2002) p98

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from European Union Risk assesment Report.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl acetoacetate
EC Number:
205-516-1
EC Name:
Ethyl acetoacetate
Cas Number:
141-97-9
Molecular formula:
C6H10O3
IUPAC Name:
ethyl 3-oxobutanoate

Test animals

Species:
other: human
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily

Results and discussion

Effect levels

Dose descriptor:
dose level:
Effect level:
420 other: mg/day
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: It suggests that systemic health risks due to repeated dermal exposure are not expected
Remarks on result:
other: not specified

Target system / organ toxicity

Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
In a study on ethyl acetoacetate, repeated dermal exposure of 420 mg/day suggested that systemic health risks due to repeated dermal exposure are not expected.
Executive summary:

In a study on ethyl acetoacetate, repeated dermal exposure of 420 mg/day suggested that systemic health risks due to repeated dermal exposure are not expected.