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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 3, 1984 until July 6, 1984; report date: October 4, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
OECD guideline No. 404, adopted
May 12, 1981
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(benzothiazol-2-ylthio)succinic acid
EC Number:
401-450-4
EC Name:
(benzothiazol-2-ylthio)succinic acid
Cas Number:
95154-01-1
Molecular formula:
C11H9NO4S2
IUPAC Name:
2-(1,3-benzothiazol-2-ylsulfanyl)butanedioic acid
Test material form:
solid
Details on test material:
(benzothiazol-2-ylthio)succinic acid, Batch: 1

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
KFM-NZW
Details on test animals or test system and environmental conditions:
The albino rabbit is the recommended species for skin irritation / corrosion studies.

Animal Strain: New Zealand white rabbits (KFM-NZW)
Sex: female rabbits
Breeder: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf


TEST ANIMALS

- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages, identified with individually numbered ear tags
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland; All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
- Water (e.g. ad libitum): ad libitum fresh water; The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972) .
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): constant room temperature of 20+/-3 °C
- Humidity (%): relative humidity of 30-70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches
Number of animals:
3
Details on study design:
An area of about 6 sq.cm was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch bearing 0.5 g of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water.
The patches were covered with an occlusive membrane and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg) . The animals were checked daily for systemic symptoms and mortality.
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
The irritant/corrosive potency of the test item was classified according to the EEC commission directive No. 83/467/1983

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
control animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
control animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
control animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
control animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
control animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
control animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
treated animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
treated animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
treated animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
treated animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
treated animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
treated animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
ERYTHEMA
Animal No. 10F 11F 12F
CF TF CF TF CF TF
After 1 hr. 0 0 0 0 0 0
After 24 hrs. 0 0 0 0 0 0
After 48 hrs. 0 0 0 0 0 0
After 72 hrs. 0 0 0 0 0 0
Mean
24-72 hrs. 0 0 0 0 0 0

EDEMA
Animal No. 10F 11F 12F
CF TF CF TF CF TF
After 1 hr. 0 0 0 0 0 0
After 24 hrs. 0 0 0 0 0 0
After 48 hrs. 0 0 0 0 0 0
After 72 hrs. 0 0 0 0 0 0
Mean
24-72 hrs. 0 0 0 0 0 0

CF = Control flank
TF = Test compound treated flank
Other effects:
There are no effects on body weights observed.

Body weights [g]
Animal No. 10F 11F 12F
Start of test 1840 2040 2030
Day 2 1865 2130 2000
Day 3 (End of test) 1910 2110 2070

Applicant's summary and conclusion

Conclusions:
Under the present conditions, there were no signs of irritation. Therefore, it can be concluded that the test item has no primary skin irritating potency in albino rabbits.
Executive summary:

The test item (benzothiazol-2-ylthio)succinic acid was tested for its skin irritaion/ corrosion properties in female albino rabbits according to the OECD 404 guideline.

A gauze patch bearing 0.5 g of the test substance was applied to the flank of the rabbit, moistened with distilled water and covered occlusively for 4 hours. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the test was ended after the 72 hours evaluation.

It can be concluded that te test item has no primary skin irritating potency in albino rabbits.