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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975-10

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

No indication of the method used to examine ocular reactions. For three of the six rabbits, eyes rinsed after 30 seconds after the test substance application. Without recording of body weight and clinical signs.

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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)
- Housing: Individually
- Diet: Ad libitum, commercial irradiated diet (Styles-Oxoid)
- Water: Ad libitum
- Acclimation period: 1 week

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated right eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 mg

Duration of treatment / exposure:

3 rabbits: eye lid held close for one second, no further washing
3 rabbits: eye lid held close for one second, then flushing with warm water for one minute

Observation period (in vivo):

72 h (examination after 1h, 6h, 48h and 72h)

Number of animals or in vitro replicates:

3 rinsed eyes
3 non-rinsed eyes

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Warm water for 1 m (3 animals out of 6)
- Time after start of exposure: 30 s

SCORING SYSTEM: Draize Score (cornea scores 0 - 4, iris scores 0 - 2, conjunctiva scores 0-4 for chemosis and 0 - 3 for redness and discharge)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

1.6

Max. score:

4

Reversibility:

fully reversible within: 6h

Remarks on result:

other: no chemosis at later observation time points. Results based on animals with non-rinsed eyes.

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 6h and 24h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48h

Remarks on result:

other: No redness observed at later observation time points. Results based on animals with non-rinsed eyes.

Results 3

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

other: 1 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 6 h

Remarks on result:

other: No further discharge observed at later observation time points. Results based on animals with non-rinsed eyes.

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h, 24h, 48h and 72h

Score:

0

Max. score:

4

Remarks on result:

other: Results based on animals with non-rinsed eyes.

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1h, 24h, 48h and 72h

Score:

0

Max. score:

2

Remarks on result:

other: Results based on animals with non-rinsed eyes.

Irritant / corrosive response data:

No indication of eye corrosion observed.

Other effects:

Results are not different if the rinsed eyes are evaluated.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is a minimal eye irritant in the albino rabbit.