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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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