Dioctadecyl 3,3'-thiodipropionate

Endpoint summary

Description of key information

The test article caused temporary mild transient reactions in rabbit eyes and on rabbit skin. The procedure for skin testing involved 24h exposure and is more stringent than OECD testing guideline 404. Experimental data on respiratory irritation is not available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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.

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

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

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)

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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

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

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)

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.

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.

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.

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.

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.

Interpretation of results:

GHS criteria not met

Conclusions:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The two studies for skin and eye irritation were performed prior to the introduction of OECD testing guidelines and GLP. As such, they have some limitations in reporting details referring to the test item and the housing conditions. Nevertheless, the available information is considered sufficient to assess the irritation hazard. The study for skin irritation was performed according to the method given in the "Hazardous-Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). This method is more stringent than the one outline in OECD testing guideline 404. In cases like this where findings were healed within the observation period, it is suitable for hazard assessment based on EU regulations.

 

The study for eye irritation follows a design comparable to that of OECD testing guideline 405 and is adequately reported. The substance was applied at 100 mg into one eye of six animals. For three of them eyes were rinsed with water 30 seconds after application. A very slight to slight conjunctival reaction was seen in five of six treated eyes one hour after application of the compound. It resolved within 24h so that overall, the substance is considered to be non irritating.

The study for skin irritation was performed with a design that is more stringent compared to OECD testing guideline 404. Reporting details are adequate for assessment, noting that some details such as body weight and housing conditions were not reported. The substance was applied onto shaved intact or abraded rabbit skin at 0.5 g under an occlusive wrapping for 24h. It was applied using 50% polyethylene glycol as vehicle. For intact skin, one rabbit showed both a slight to well defined erythema and edema with a Draize score of 2 and two other rabbits showed very slight oedema with a Draize score of 1 one day after the application of the compound. The mean Draize scores for 24h were 0.33 for erythema and 0.67 for edema. As all sites were normal by 72 hours the study is considered suitable for classification and labelling. Application onto abraded skin resulted in slightly higher mean scores (0.83 for erythema and 1.17 for edema).

Experimental data on respiratory irritation is not available.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No. 1272/2008.