Didodecyl 3,3'-thiodipropionate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with restrictions (evaluation after 48 hours is missing; occlusive dressing; test substance was applied as a 50 % solution of which 1mL/test site was used; exposure period of 24 hours)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(evalutation after 48 hours is missing; occlusive dressing; test substance was applied as a 50 % solution of which 1 mL/test site was used; exposure period of 24 hours)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Didodecyl 3,3'-thiodipropionate

EC Number:

204-614-1

EC Name:

Didodecyl 3,3'-thiodipropionate

Cas Number:

123-28-4

Molecular formula:

C30H58O4S

IUPAC Name:

didodecyl 3,3'-sulfanediyldipropanoate

Details on test material:

- Name of test material (as cited in study report): IRGANOX PS 800
- Physical state: white powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 11 - 17 weeks
- Weight at study initiation: 2.3 kg (males) and 2.98 kg (females)
- Housing: individually
- Diet: commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: sterile filtered, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved with and without abrasion

Vehicle:

other: polyethylene glycol

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 mL/test site
- Concentration (if solution): 50 % (w/v) in polyethylene glycol

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: back
- % coverage: 10 % of the total body surface
- Type of wrap if used: The test substance was applied to each test site on a 2.5x2.5 cm² gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6" wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24 and 72 hours

Score:

0.09

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin site

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

other: mean over 24 and 72 hours

Score:

0.6

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin site

Other effects:

None reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information