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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: meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
2 animals were treated for 20 hours under occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the powdered and moistened test substance. The animals were observed for 8 days and skin changes were recorded on working days. The report describes findings after 24 hours and at the end of the observation period.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthalene-2-sulphonic acid
EC Number:
204-375-3
EC Name:
Naphthalene-2-sulphonic acid
Cas Number:
120-18-3
Molecular formula:
C10 H8 O3 S
IUPAC Name:
naphthalene-2-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): beta-Naphthalinsulfonsaeure, Picaltal fest
- Physical state: solid
- Analytical purity: technical grade (no further data)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2,83 and 3,64 kg
no further data


ENVIRONMENTAL CONDITIONS
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreates skin of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified, generally 1 g/ 1 mL
- Concentration (if solution): 80%
Duration of treatment / exposure:
20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm, back skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done):: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50% (mild detergent) was used. No washing was done after the 20 h treatment.


SCORING SYSTEM: Descriptive scores of the raw data were converted into OECD/Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
20 h exposure
Time point:
other: 24 - 48 - 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: full-thickness necrosis observed in both animals, see table for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
20 h exposure
Time point:
other: 24 - 48 - 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
mean
Remarks:
15 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: superficial necrosis observed in 1/2 animals
Irritation parameter:
edema score
Basis:
mean
Remarks:
15 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
mean
Remarks:
5 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
5 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Remarks:
1 min exposure
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Exposition:  20 h
Animal  Reading  Erythema Edema Comment
1 24 h 2 0 2 cm anemic
2 24 h 2 2 anemic
1 48 h 2 0 2 cm anemic
2 48 h 2 0 anemic/ parchmenty necrosis
1 72 h 2 0 2 cm parchmenty necrosis
2 72 h 0 0 anemic parchmenty necrosis
1 4 d 2 0 2 cm parchmenty necrosis
2 4 d 0 0 anemic parchmenty necrosis
1 7 d 0 0 2 cm leather-like necrosis
2 7 d 0 0 leather-like necrosis
1 8 d 0 0 2 cm hard necrosis
2 8 d 0 0 leather-like necrosis
1 24 - 72 h 2.00 0.00  
2 24 - 72 h 1.33 0.67  
mean 24 - 72 h 1.67 0.33  
Exposition:  15 min
Animal  Reading  Erythema Edema Comment
1 24 h 2 0  
2 24 h 3 2 partially anemic
1 48 h 2 0  
2 48 h 3 2 partially whitish, pea-sized anemic area
1 72 h 2 0  
2 72 h 2 0 partially whitish, pea-sized anemic area
1 4 d 2 0  
2 4 d 2 0 partially whitish, pea-sized anemic area
1 7 d 0 0 parchmenty spotted necrosis
2 7 d 2 0 scaling, crusty
1 8 d 0 0 superficial crusts
2 8 d 2 0 scaling, crusty
1 24 - 72 h 2.00 0.00  
2 24 - 72 h 2.67 1.33  
mean 24 - 72 h 2.33 0.67  
         
Exposition:  5 min
Animal  Reading  Erythema Edema Comment
1 24 h 1 0  
2 24 h 1 0  
1 48 h 1 0  
2 48 h 0 0  
1 72 h 0 0  
2 72 h 0 0  
1 4 d 0 0  
2 4 d 0 0  
1 7 d 0 0  
2 7 d 0 0  
1 8 d 0 0  
2 8 d 0 0  
1 24 - 72 h 0.67 0.00  
2 24 - 72 h 0.33 0.00  
mean 24 - 72 h 0.50 0.00  
         
Exposition:  1 min
Animal  Reading  Erythema Edema Comment
1 24 h 0 0  
2 24 h 0 0  
1 48 h 0 0  
2 48 h 0 0  
1 72 h 0 0  
2 72 h 0 0  
1 4 d 0 0  
2 4 d 0 0  
1 7 d 0 0  
2 7 d 0 0  
1 8 d 0 0  
2 8 d 0 0  
1 24 - 72 h 0.00 0.00  
2 24 - 72 h 0.00 0.00  
mean 24 - 72 h 0.00 0.00  

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU

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