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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:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is similar or equivalent to guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: JO RF 21/4/71, 5/6/73
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test compound: TPS 37
Chemical name: di-t-nonyl polysulfide
CAS no.: 68425-16-1
Source: Elf Aquitaine
Batch: no data
Total sulfur: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: kept in individual cages measuring 540 x 360 x 315 mm, cages are ventilated
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: right flank scarified, left flank in tact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of liquid TPS 37 were applied per zone (2 zones were tested).
Duration of treatment / exposure:
23 hours
Observation period:
2 days, readings taken at 24 and 72 hours of beginning of the test.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 14 x 14 cm
- Type of wrap if used: four layers of gauze pads (2cm square) under a patch with a surrounding adhesive, hypoallergenic, perforated plaster 10 mm wide. Adhesive tape is wound around the animal to complete fixing the patches.
- Other: The right flank is scarified with a sterile scalpel blade, making three parallel superficial incisions 2 cm long and 0.5 cm apart. The incisions are epidermal and do not damage the dermis. The test substance is applied to both the intact left flank and scarified right flank.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM:
Erythema
No erythema =0
Very slight erythema =1
Well defined erythema =2
Moderate to severe erythema =3
Severe erythema, crimson red, with slight eschar formation =4

Oedema
No oedema =0
Very slight oedema = 1
Slight oedema=2
Moderate oedema=3
Severe oedema = 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.88
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.167
Max. score:
4
Reversibility:
not fully reversible within: 72 hours

Any other information on results incl. tables

Evaluation of irritation

 

Rabbits N

 

Zones

24 hours

72 hours

Total

Erythema

Oedema

Total

Erythema

Oedema

Total

(24 h + 72 h)

175 bis

Normal

2

1

3

2

1

3

6

Scarified

2

1

3

2

1

3

6

176

Normal

0

0

0

0

0

0

0

Scarified

1

0

1

0

0

0

1

177

Normal

2

0

2

2

0

2

4

Scarified

2

0

2

2

0

2

4

178

Normal

2

0

2

2

0

2

4

Scarified

2

0

2

2

0

2

4

179

Normal

2

0

2

2

0

2

4

Scarified

2

0

2

2

0

2

4

180

Normal

2

0

2

2

0

2

4

Scarified

2

0

2

2

0

2

4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
TSP 37 is classified as slightly irritating based on the dermal irritation index and scoring after application of .5 mL of test material to the rabbits.
Executive summary:

In a primary dermal irritation study, male New Zealand white rabbits were dermal exposed (using a patch) to 0.5 mL of liquid TPS 37 for 23 hours and observed for 72 hours. Pads containing TPS 37 were placed on the skin covering the right flank, which had been scarified, and to the left flank, which was still intact. Irritation was scored using the index of primary irritation.

 

After 23 hours, the skin patches were removed and erythematous lesions were noted. Either no erythema, very slight, or well defined erythma were observed among test animals. Oedmatous lesions were also noted. Test animals were only observed to have no oedema, very slight, or slight oedma. In this study, TPS 37 is classified as slightly irritating based on the dermal irritation index and scoring after application of .5 mL of test material to the rabbits for 24 hours.

 

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is similar or equivalent to JO RF 21/4/71, 5/6/73.