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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexanal
EC Number:
204-596-5
EC Name:
2-ethylhexanal
Cas Number:
123-05-7
Molecular formula:
C8H16O
IUPAC Name:
2-ethylhexanal
Details on test material:
- Name of test material (as cited in study report): 2-ethylhexanal
- Physical state: 99%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours
7 and 14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h - 48 h -72 h
Score:
2.1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

1 h - 72 h post application slight to moderate erythema and very slight edema was noted. The skin was dry, rough and fissured. One hour after application 1 animal showed white discoloration and 72 h post application 2 animals showed light brownish discoloration of the skin. The skin irritation effects were reversible within 14 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with the criteria of EU Directive 67/548/EEC, 2-Ethylhexanal is classified as skin irritating (R38). The criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 are not met.
Executive summary:

The potential of 2 -Ethylhexanal to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 ml of the test substance to the intact skin of 3 white New Zealand rabbits for 4 hours under semi-occlusive dressing. The average score (24, 48 and 72 hours) for irritation was calculated to be 2.1 for erythema and 0.9 for edema. The irritation findings were reversible in all animals within 14 days. In accordance with the criteria of EU Directive 67/548/EEC, 2-Ethylhexanal is classified as skin irritating (R38). The criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 are not met.