Didodecyl 3,3'-thiodipropionate

Endpoint summary

Description of key information

similar to OECD 404: not irritating to skin

similar to OECD 405 (Read-across to dioctadecyl 3,3'-thiodipropionate): not irritating to eye

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:

1975-09

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)

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)

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
- 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

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

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

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

Interpretation of results:

not irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1975-09

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Comparable to guideline study with restrictions (light/dark cycle 10/14 instead of 12/12; unjustified use of a satellite group; only conjunctivae was examined; tools used to assess score are not mentioned; individual weight at the end of the test are not indicate)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

(light/dark cycle 10/14 instead of 12/12; unjustified use of a satellite group; only conjunctivae was examined; tools used to assess score are not mentioned; individual weight at the end of the test are not indicate)

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.

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
- 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

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 hours and 30 sec. In the latter, the compound was flushed out of the eyes of three of the rabbits with warm water for 1 minute.

Observation period (in vivo):

21 days
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Details on study design:

The test compound was instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control.
REMOVAL OF TEST SUBSTANCE
After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

SCORING SYSTEM: Draize scoring system

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of 6 animals

Time point:

other: 1 hour

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: values for unrinsed eyes

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of 6 animals

Time point:

other: mean over 24, 48 and 72h

Score:

0

Max. score:

3

Remarks on result:

other: values for unrinsed eyes

Other effects:

None reported

There was no difference between rinsed and unrinsed eyes.

Interpretation of results:

not irritating

Remarks:

Migrated information

Reference 2

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:

other: Non GLP. Comparable to OECD 405, without recording of body weight and clinical signs.

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.

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 w

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: 0.1 g

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:

not irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritation

In the study of CIBA-Geigy (No. 46275SL, 1975), the potential of the test substance to cause acute dermal irritation or corrosion was assessed by single topical application of an amount of 1 mL of the test substance, diluted to 50 % (w/v) in polyethylene glycol, for 24 hours to the intact skin of 3 male and 3 female White New Zealand rabbits using a gauze patch of 2.5 x 2.5 cm. The patch was 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. The cutaneous reactions were assessed 24 and 72 hours after removal of the patch.

Mean 24 -72-hour scores were 0.09 and 0.6 for erythema and edema, respectively. The effects were fully reversible within 72 hours in all animals. No other effects were reported.

Eye Irritation

The study for eye irritation (CIBA 47075BL, 1975), for the C18 alkyl chain analogue dioctadecyl 3,3-thiodipropionate, follows a design comparable to that of OECD testing guideline 405 and is adequately reported. The substance was applied at 0.1 g 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.

In a CIBA-Geigy (No. 46775SL, 1975) study, the potential of the test substance to cause damage to the eye was assessed by a single ocular application of 0.1 g of the test substance to one eye of each of 3 male and 3 female White New Zealand rabbits (in 3 animals, approximately 30 seconds after treatment the treated eye was washed with warm water for 1 minute). The ocular reactions for conjunctiva was assessed 24, 48 and 72 hours after application.

Mean 24-48-72-hour score for the 6 animals (there was no difference between rinsed and unrinsed eyes) were 0 for conjunctiva. Corneal opacity, iris lesions, and chemosis were not investigated. No other effects were observed. Overall, the test substance does not show an eye irritation potential under the test conditions chosen.

 

Respiratory irritation

No data 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 the purpose of classification under Regulation (EC) No.1272/2008.

Based on the data, the test subtance has not to be classified as skin or eye irritatant.