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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-dithiodi(benzoic acid)
EC Number:
204-352-8
EC Name:
2,2'-dithiodi(benzoic acid)
Cas Number:
119-80-2
Molecular formula:
C14H10O4S2
IUPAC Name:
2-[(2-carboxyphenyl)disulfanyl]benzoic acid
Test material form:
other: Solid
Details on test material:
The test material had a purity of 75.7%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Conventional Animal Breeding Unit
- Age at study initiation: young adult
- Weight at study initiation:3184-3601g
- Housing: aluminium sheet cages 65.2x68.9x45.7cm
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19
- Humidity (%): 40-70
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: corn oil
Controls:
not required
Amount / concentration applied:
-test substance concentration: 500mg in 0.5ml corn oil
-application site: 2.5x2.5cm
Duration of treatment / exposure:
4 hours
Observation period:
30-60min, 1, 2, 3, 4, 7, 10 days post dressing removal
Number of animals:
3 females
Details on study design:
-assessment: Draize scale
-calculations: mean erythema and oedema scores calculated from days 1, 2 and 3 readings

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 days
Other effects:
The application site of all animals was stained beige by test sample but this did not prevent the assessment of irritation.

Any other information on results incl. tables

Results:

Animal No.

Erythema/Oedema Scores

30-60m

1d

2d

3d

4d

7d

10d

14d

13 (#1)

2/1

2/1

2/1

2/1

2/0

1/0

0/0

0/0

14 (#2)

0/0

1/2

2/2

2/2

1/1

1/0

1/0

0/0

15 (#3)

1/0

1/1

1/1

1/1

1/0

0/0

0/0

0/0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DTBA was a mild irritant to rabbit skin