2-Decyltetradecyl 3-[3-(2-decyltetradecoxy)-3-oxopropyl]sulfanylpropanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975-12

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Justification for type of information:

Thiobis Propanoic Acid Derivatives
The category covers thiiodipropionates that are symmetrically esterified by two linear aliphatic groups ranging in size from C10 to C24
The justification for the category is based on the expectation that the close structural similarity should result in properties that are either similar or follow a pattern that correlates with changes in the molecular weights of the compounds. The category members are high-molecular weight dithiopropionate esters that differ only in the chain length of the dialkyl ester functions and are expected to follow a regular pattern for all endpoints.
Based on the structures and molecularweights of the category members, as well as available data on category members, The predictive methods and extrapolation and interpolation of data within the category are acceptable. Data provided by other sources also demonstrate that these compounds generally have mammalian toxicities that are similar (e.g., acute oral LD 50, acute irritation thresholds, and genotoxicities) or follow a pattern that parallels changes in molecular weight (e.g., repeated-dose NOAEL).

The category is adequately supported based on chemical structure and available data.

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:

No information on housing and light period of 10 h/d. No controls. Patch size too small. Procedure more stringent than OECD testing guideline (24h occlusive application). Considered acceptable since only mild and reversible findings observed.

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:

Dioctadecyl 3,3'-thiodipropionate

EC Number:

211-750-5

EC Name:

Dioctadecyl 3,3'-thiodipropionate

Cas Number:

693-36-7

Molecular formula:

C42H82O4S

IUPAC Name:

dioctadecyl 3,3'-sulfanediyldipropanoate

Details on test material:

- Substance type: Organic
- Physical state: Solid, white granules

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 and maintained under a semi-barrier system
- Age at study initiation: 11 - 12 weeks
- Weight at study initiation: 2.41 kg (males); 2.24 kg (females)
- Diet: Ad libitum, commercial irradiated diet (Styles-Oxoid)
- Water: Ad libitum
- Acclimation period: 1 w

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 and abraded

Vehicle:

other: polyethylene glycol

Controls:

no

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL
- Concentration (if solution): 50 %

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Back
- % coverage: 10 %
- Type of wrap if used: Aluminium foil secured with "Sleek" adhesive tape and enclosed by a 6' wide "Coban" self adhesive bandage fixed to the skin by strips of "Sleek"

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

SCORING SYSTEM: Draize (scores of 0 - 4 for erythema/eschar and edema)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0.83

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: abraded skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: abraded skin

Irritant / corrosive response data:

Slight to well defined erythema and very slight to moderate oedema were seen on 3/6 rabbits, 24 hours after the application of the compound. All sites were normal by 72 hours.
The primary irritation score was 0.75.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item caused mild skin irritation within 24h that completely healed within 72h if applied occlusively for 24h.