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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test was based on the OECD Guidelines for Testing Chemicals (OECD, 1981) and the EEC Dangerous Substances Directive.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Not applicable.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetaldehyde
EC Number:
200-836-8
EC Name:
Acetaldehyde
Cas Number:
75-07-0
Molecular formula:
C2H4O
IUPAC Name:
acetaldehyde
Details on test material:
0.5 mL/patch

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
1 hour and 4 hours
Observation period:
The results were assessed 1, 24, 48 and 72 hr and 7 days after removel of the patch.
Number of animals:
Six rabbits were used (three adults male and three adults female).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 hr
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
other:
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
test performed in 1984
Irritation parameter:
edema score
Basis:
other:
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
not measured/tested
Remarks:
test performed in 1984

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritation/corrosion results showed that Acetaldeyde is not irritating to the rabbit skin after 4-hr exposure, using the semi-occlusive method, even after a 4-hr occlusive application the substance is "non-irritant.
Executive summary:

The test was based on the OECD Guidelines for Testing Chemicals (OECD, 1981) and the EEC Dangerous Substances Directive.

The skin irritation/corrosion results showed that Acetaldeyde is not irritating to the rabbit skin after 4-hr exposure, using the semi-occlusive method. The semi-occlusive method is stongly advocated in the case of volatile substance.

Acetaldehyde is labelled as irritant in Annex I of the directive (EEC, 1967 and amendments), but the skin result, even after a 4 -hr occlusive application ("non-irritant"), suggest that the classification is mainly because of potential irritation to the eye and/or the respiratory tract. Therefore, the substance will be not classified as skin irritant according to EU Criteria.