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EC number: 915-673-4 | CAS number: 211519-85-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- 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.
Reference
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
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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