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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984 - 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

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-hydroxy-1-naphthaldehyde
EC Number:
211-902-0
EC Name:
2-hydroxy-1-naphthaldehyde
Cas Number:
708-06-5
Molecular formula:
C11H8O2
IUPAC Name:
2-hydroxynaphthalene-1-carbaldehyde
Details on test material:
Purity: 94%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventioal breeding
- Weight at study initiation: 1.9 - 2.4 kg
- Housing: in completely air conditioned rooms in single cages
- Diet: Altromin 2123 Haltungsdiat - Kaninchen (ad libitum):
- Water : deionized and chlorinated water from automatic suspendors (ad libitum):

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod : 12 hours daily

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
other: Polyethyleneglycol 400
Controls:
no
Amount / concentration applied:
500 mg test item suspended in 0.2 ml Polyethyleneglycol 400
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:2.5 cm x 2.5 cm
- % coverage: 100
- Type of wrap if used: plaser

REMOVAL OF TEST SUBSTANCE
- Washing (if done):with slightly warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: within 7 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 14 days
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 7 days
Score:
0
Max. score:
4
Remarks on result:
other: animal has died
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 7 days
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72 h
Score:
0
Max. score:
4
Other effects:
Animal #2 died before day 7 in the observation period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritating to the skin.
Executive summary:

The substance was tested for skin irritation according to OECD guideline 404. 3 albino Newzealand rabbits were administered 500 mg of the test item suspended in 0.2 ml Polyethyleneglycol 400 with a semiocclusive coverage. Contact time was 4 hours and the observation period after removal of the substance was 14 days. from 48 hours to 7 days after removal of the substance the skin was dry, rough, fine scaled, parchment -like and chapped. 14 days after the application the animals showed no irritating symptoms at the skin. During the night from day 6 to day 7 one rabbit died without signs of intoxication. This animals had no signs of irritation at this point of time.

Based on the results, the substance has not to be classified as irritating to the skin