Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-03-23 to 1982-06-18
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD Guideline not under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Acetaldehyde was obtained as clear bright fluid.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: from the own breeding station
- Age at study initiation: no data
- Weight at study initiation: 2,2 to 3,1 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3 °C
- Humidity (%): 50 +/-5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Type of coverage:
other: semiocclusiv and occlusiv
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL on each application site (right and left cranial and caudal flank)
Duration of treatment / exposure:
1 hour and 4 hours were tested simultaneously on the same animal
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 3x3 cm
- Three animals: left cranial flank 1 hour occlusive, right cranial flank 4 hours occlusive, left caudal flank 1 hour semiocclusive and right caudal flank 4 hours semiocclusive
- Three animals: left cranial flank 4 hours semiocclusive, right cranial flank 1 hour semiocclusive, left caudal flank 4 hours occlusive and right caudal flank 1 hour occlusive


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Remarks:
semi-occlusive
Time point:
other: 1, 24, 48 hr and 7 days
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #2
Remarks:
semi-occlusive
Time point:
other: 1, 24, 48 hr and 7 days
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Remarks:
semi-occlusive
Time point:
other: 1, 24, 48 hr and 7 days
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #4
Remarks:
occlusive
Time point:
other: 1, 24, 48 hr and 7 days
Score:
0
Max. score:
0
Remarks on result:
probability of weak irritation
Remarks:
some discolorization fo skin that was reversible after 48 hr
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 1, 24, 48 hr and 7 days
Score:
0
Max. score:
0
Remarks on result:
probability of weak irritation
Remarks:
some discolorization of skin that was reversible after 48 hr
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 1, 24, 48 hr and 7 days
Score:
0
Max. score:
0
Remarks on result:
probability of weak irritation
Remarks:
some discolorization of skin that was reversible after 48 hr
Irritant / corrosive response data:
see remarks on results
Other effects:
The treated area was stained brown.

Any other information on results incl. tables

Due to the high volatility of the substance Acetaldehyde (boiling point 20.4°C), a relevant study accoring to OECD 404 was not possible. The observed slight irritations, as measured by skin discolorizatoin and not erythema or edema,

under occlusive dressing were reversible within 48 hours.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information (occlusive dressing only) Criteria used for interpretation of results: not specified
Conclusions:
Due to the high volatility of the substance Acetaldehyde (boiling point 20.4°C), a study with appropriate exposure duration accoring to OECD 404 was not possible. But according to the reported effects, Acetaldehyde was only slight irritant under the conditions of the test.
Executive summary:

Acetaldehyde was investigated for skin irritation potential accoring to OECD Guideline 404. Due to the high volatility of the chemical the demanded exposure duration could not be maintained even under occlusive dressing. Nevertheless, the reported effects do not justify a classification as irritant.