Polysulfides, di-tert-dodecyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Polysulfides, di-tert-dodecyl

EC Number:

270-335-7

EC Name:

Polysulfides, di-tert-dodecyl

Cas Number:

68425-15-0

Molecular formula:

not applicable

IUPAC Name:

di (alkyl C11-C13 Branched, C12 Rich), polysulfure S3-S5 rich

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 +/- 0.2 kg
- Housing: individual housing in polystyrene cages
- Diet (ad libitum): Rabbit complete pelleted maintenance food (UAR, France)
- Water (ad libitum): softened and filtered drinking wated
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hour(s)

Observation period:

1, 24, 48 and 72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure:
- Surface of coverage: 6 cm²
- Type of wrap if used: wide perforated tape applied on a crimped gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.72

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.39

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritant / corrosive response data:

TPS 32 produced a slight erythema in one rabbit and a moderate erythema  in 5 rabbits.  A slight oedema was observed in 3 rabbits. 

Any other information on results incl. tables

See attached document

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Di-t-dodecyl polusulfides was considered as slightly irritating for the skin.

Executive summary:

In a study similar to OECD TG 404, primary skin irritation in rabbits was evaluated for di-t-dodecyl polysulfides (TPS 32). Six rabbits (strain not specified) were exposed to undiluted di-t-dodecyl polysulfide under semi-occlusive conditions for four hours. Slight erythema was noted in one rabbit, and moderate erythema was noted in five rabbits. Slight edema was noted in three of six rabbits. Mean scores over 24, 48 and 72h were 1.72 for erythema and 0.39 for edema. Di-t-dodecyl polusulfides was considered as slightly irritating for the skin.