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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
of 1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-hydroxy-2-naphthoic acid
EC Number:
202-180-8
EC Name:
3-hydroxy-2-naphthoic acid
Cas Number:
92-70-6
Molecular formula:
C11H8O3
IUPAC Name:
3-hydroxynaphthalene-2-carboxylic acid
Details on test material:
- Name of test material (as cited in study report): BONS TTR

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG breeding colony
- Weight at study initiation: 2,2 - 2,6 kg
- Housing: single cages
- Diet (e.g. ad libitum): Rabbit diet Altromin 2123, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/-10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
0.5 g test substance mixed with 0.32 ml polyethylene glycol 400
Duration of treatment / exposure:
4 hours (patch removal and removal of residual test material 4 h post application)
Observation period:
72 hours post patch removal
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Other effects:
No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The mean Draize scores for erythema and edema derived from 24, 48 and 72 hour post treatment observation time points were 0.3 in each of three rabbits. All erythema and edema findings were completely reversible within 48 hours post patch removal. Based on these findings the test substance was considered "not irritant".
Executive summary:

The test item was tested for skin irritation according to OECD Guideline 404 and in compliance with GLP. Each of three New Zealand White rabbits was treated for 4 hours by semi-occlusive administration of a single dose of 0.5 g test substance mixed with polyethylene glycol 400 to shaved intact skin. The site of administration was examined for skin reactions at 0.5-1, 24, 48 and 72 hours post patch removal. Very slight erythema and edema (both barely perceptible) were observed 1 hour and 24 hours after removal of the patches. Draize scores for erythema and edema were 0.3 each for each animal. The effects were completely reversible within 48 hours post patch removal. Based on these findings the test substance was considered "not irritant".