Polysulfides, di-tert-nonyl

Skin irritation / corrosion

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:

guideline study with acceptable restrictions

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

Guideline:

other: JO RF 21/4/71, 5/6/73

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Polysulfides, di-tert-nonyl

EC Number:

270-336-2

EC Name:

Polysulfides, di-tert-nonyl

Cas Number:

68425-16-1

Molecular formula:

C78H110O6S5

IUPAC Name:

bis(1,1,2,3,3-pentamethylbutyl)trisulfane

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 or test system 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

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

1.88

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 6

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 7

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 13

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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:

Category 3 (mild irritant) based on GHS criteria

Remarks:

Not classified according to Regulation (EC) No. 1272/2008

Conclusions:

TSP 37 is classified as slightly irritating based on the dermal irritation index and scoring after application of 0.5 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 0.5 mL of test material to the rabbits for 24 hours. It does not meet the criteria for classification as a skin irritant according to Regulation (EC) No 1272/2008.

 

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.