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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Monographs of Fragrance Raw Materials for the test material
Author:
D.L.J Opdyke
Year:
1978
Bibliographic source:
Food and Cosmetics Toxicology,1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
other: Human maximization test
Justification for non-LLNA method:
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 material form:
liquid
Details on test material:
- Name of test material (IUPAC Name): Ethyl acetoacetate- Molecular formula: C6H10O3- Molecular weight: 130.142 g/mol- Smiles notation: C(C(=O)OCC)C(=O)C- InChI: 1S/C6H10O3/c1-3-9-6(8)4-5(2)7/h3-4H2,1-2H3- Substance type: Organic- Physical state: Liquid

In vivo test system

Test animals

Species:
other: humans
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
Day(s)/duration:
no data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
26
Details on study design:
no data available
Challenge controls:
no data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
8% in petroaltum
No. with + reactions:
0
Total no. in group:
26
Clinical observations:
no signs of sensitization observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 26 human volunteers.Hence, the test chemical was considered to be not sensitizing to skin.
Executive summary:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 26 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified).

The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 26 human volunteers.

Hence, the test chemical was considered to be not sensitizing to skin.