Polysulfides, bis[3-(triethoxysilyl)propyl]

Endpoint summary

Description of key information

In a skin irritation/corrosion study with bis[3-(triethoxysilyl)propyl]polysulfides (CAS No. 211519-85-6, EC No. 915-673-4) conducted according to a standard guideline similar to OECD Test Guideline 404 with acceptable restrictions but which pre-dated GLP, the test material was concluded to be not irritating to rabbit skin (Laboratorium fűr Pharmakologie und Toxikologie, 1976a).

 

In an eye irritation/corrosion study with bis[3-(triethoxysilyl)propyl]polysulfides conducted according to a standard guideline similar to OECD Test Guideline 405 but which pre-dated GLP, the test material was concluded to be not irritating to the eyes of rabbits (Laboratorium fűr Pharmakologie und Toxikologie, 1977c).

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: FDA (1965). Part 191, Section 11.

Deviations:

not applicable

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No information available
- Age at study initiation: No information available
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: Animals were individually housed in V2A steel cages with a ground area of 0.4 m2
- Diet: ALTROMIN 2023 ad libitum except during treatment
- Water: Tap water ad libitum except during treatment
- Acclimation period: No information available


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°
- Humidity (%): 60 ± 3%
- Air changes (per hr): No information available
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: No information available

Type of coverage:

occlusive

Preparation of test site:

other: Shaved, intact (3 animals) or abraded (3 animals)s

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration (if solution): Neat

Duration of treatment / exposure:

24 h exposure

Observation period:

Observed at 48, 72, 96 and 120 h following application.

Number of animals:

6 (3 male, 3 female), with 3 intact and 3 abraded

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: No information available
- Type of wrap: Plastic foil fastened with a gum patch.


REMOVAL OF TEST SUBSTANCE
- Washing: No information available


SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

abraded skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

No skin reactions or clinical signs were observed in any animal. Re-growth of hair was unaffected by treatment. See Table 1 below.

Table 1: Irritant/corrosive response data for each animal at each observation time point up to removal of each animal from the test

Score at time point*/ Reversibility	Erythema	Oedema
	Max. score: 4	Max. score: 4
24 h (removal of patch)	0/0/0/0/0/0	0/0/0/0/0/0
48 h (24h following removal)	0/0/0/0/0/0	0/0/0/0/0/0
72 h (48h following removal)	0/0/0/0/0/0	0/0/0/0/0/0s
96 h (72h following removal)	0/0/0/0/0/0	0/0/0/0/0/0
120 h (96h following removal)	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h (following removal)	0	0
Reversibility**	n/a	n/a
Average time (unit) for reversion	n/a	n/a

* Results for 6 animals shown: 3 abraded, 3 non-abraded, all individual scores also equal to 0.

** Reversibility: c. = completely reversible; n.c. = not completely reversible; n = not reversible

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable skin irritation study conducted in accordance to an appropriate national test guideline similar to OECD Test Guideline 404, the substance was found to be non-irritant to rabbit skin. The test pre-dated GLP.

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:

December 1976 - no further details

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: FDA (1965). Part 191, Section 11.

Deviations:

not applicable

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.3-2.8 kg
- Housing: 1/cage
- Diet (e.g. ad libitum): standard diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-2
- Humidity (%): 60 +/- 3
- Photoperiod (hrs dark / hrs light): 12 h/12 h


IN-LIFE DATES: From: To: not stated in report

Vehicle:

unchanged (no vehicle)

Controls:

other: Control is the other eye, treated with physiological saline

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat

Duration of treatment / exposure:

Single application. Exposure until end of study - apparently 72 h.

Observation period (in vivo):

24, 48 and 72 h after application.

Number of animals or in vitro replicates:

3M, 3F

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Apparently no washing.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

There was no indication of irritation in any of the 6 animals at 24, 48 or 72 h following treatment. Examinations at each time point were made using a hand slit lamp and fluorescein. See Table 1 below.

Table 1: Irritant/corrosive response data at each observation time up to removal of each animal from the test

Score at time point / Reversibility*	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	0	0	0	0
48 h	0	0	0	0
72 h	0	0	0	0
Average 24h, 48h, 72h	0	0	0	0
Area effected	0	0	0	0
Maximum average score (including area affected, max 110)	0	0	0	0
Reversibility	n/a	n/a	n/a	n/a
Average time (unit) for reversion	n/a	n/a	n/a	n/a

* Scores are average of 6 rabbits, all individusl scores were also equal to 0

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable study predating GLP conducted according to a standard guideline very similar to OECD Test Guideline 405 with acceptable restrictions, the test material was concluded to be not irritating to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key skin irritation/corrosion study with bis[3-(triethoxysilyl)propyl]polysulfides (Laboratorium fűr Pharmakologie und Toxikologie, 1976a) was selected from two studies considered reliable with restrictions. The second study followed an identical test procedure but contained 1% of an additive. Both studies showed no irritant effects. For two additional studies, the documentation insufficient for an assessment of reliability, but the results as reported did not disagree with the key study finding.

 

The key study for skin irritation with bis[3-(triethoxysilyl)propyl]polysulfides was conducted according to a standard guideline similar to OECD Test Guideline 404 with acceptable restrictions, but pre-dated GLP (Laboratorium fűr Pharmakologie und Toxikologie, 1976a). In this study, the test material was concluded to be non-irritating to rabbit skin. No skin reactions or clinical signs were observed in any animal at any time point.

 

A supporting skin irritation study with bis[3-(triethoxysilyl)propyl]polysulfides was conducted according to a standard guideline similar to OECD Test Guideline 404 with acceptable restrictions, but pre-dated GLP (Laboratorium fűr Pharmakologie und Toxikologie 1976b). The test material was not irritating to rabbit skin.

 

Two additional skin irritation studies with bis[3-(triethoxysilyl)propyl]polysulfides were available (no test guideline identified for one, a standard guideline similar to OECD Test Guideline 404 for the second, both pre-dated GLP; Laboratorium fűr Pharmakologie und Toxikologie, 1977a and b). While the results as reported did not disagree with the key study finding, no definitive conclusion about irritation potential could be drawn due to the documentation being insufficient.

 

The key study for eye irritation with bis[3-(triethoxysilyl)propyl]polysulfides was conducted according to a standard guideline similar to OECD Test Guideline 405 with acceptable restrictions but pre-dated GLP (Laboratorium fűr Pharmakologie und Toxikologie, 1977c). In this study, the test material was concluded to be non-irritating to rabbit eyes. No eye reactions or clinical signs were observed in any animal at any time point.

 

The supporting eye irritation study followed an identical test procedure but contained 1.5% of an additive. In this supporting study that pre-dated GLP, the test material also was concluded to be not irritating to the eyes of rabbits (Laboratorium fűr Pharmakologie und Toxikologie 1977d).

Justification for classification or non-classification

Based on the available data, bis[3-(triethoxysilyl)polysulfides does not require classification for skin or eye irritation according to Regulation (EC) No. 1272/2008.