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EC number: 252-161-3 | CAS number: 34708-08-2
- 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
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- 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

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because the test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Reference substance name:
- Triethoxy(3-thiocyanatopropyl)silane
- EC Number:
- 252-161-3
- EC Name:
- Triethoxy(3-thiocyanatopropyl)silane
- Cas Number:
- 34708-08-2
- Molecular formula:
- C10H21NO3SSi
- IUPAC Name:
- [3-(cyanosulfanyl)propyl]triethoxysilane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories, The Netherlands
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: 302.4 - 411.7g
- Housing: in groups of up to ten in stainless steel cages with standard softwood bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 or 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: diglyme
- Concentration / amount:
- Undiluted test substance (induction).
15% and 5% in diglyme (first challenge).
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: diglyme
- Concentration / amount:
- Undiluted test substance (induction).
15% and 5% in diglyme (first challenge).
- No. of animals per dose:
- 20 for test group, 10 for control group
- Details on study design:
- Twenty Albino Dunkin Hartley guinea pigs (males) of the test group were treated topically with the undiluted test item once a week for a 3-week induction phase. Two weeks after the last induction, the animals were challenged with 15% and 5% (weight/weight) test item in diglyme.
The ten animals of the control group 1 were not treated during the induction. The animals were challenged with 15% (the highest non-irritating concentration) and 5% (weight/weight) test item in diglyme.
Due to ambiguous results in the first challenge, a second challenge was conducted using the same test animals and ten additional naive control animals (control groups 2 and 3). The same concentrations of 15% and 5% of the test item in diglyme were used. - Challenge controls:
- Refer to table.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercapto-benzothiazole or alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Positive controls were assessed at the laboratory at least twice a year. During 2011 (prior to this experiment), the result from the positive control study had resulted in allergic contact dermatitis in >15% of the test animals when testing alpha-hexylcinnamaldehyde as a skin sensitiser. Alpha-hexylcinnamaldehyde is recommended to use by the Commission Regulation (EC) No 440/2008, B.6 and OECD 406 since it causes moderate skin sensitisation in guinea pigs. No further details are provided.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: first challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenege
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: second challenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: not specified
- Group:
- positive control
- Dose level:
- alpha-hexylcinnamaldehyde
- Remarks on result:
- other: The results from most recent the positive control study (2011 report not available) confirm alpha-hexylcinnamaldehyde as skin sensitizer, as it produced allergic contact dermatitis in >15% of the test animals.
Any other information on results incl. tables
Positive controls:
Positive controls were assessed at the laboratory at least twice a year. During 2011 (prior to this experiment), the result from the positive control study had resulted in allergic contact dermatitis in >15% of the test animals when testing alpha-hexylcinnamaldehyde as a skin sensitiser. Alpha-hexylcinnamaldehyde is recommended to use by the Commission Regulation (EC) No 440/2008, B.6 and OECD 406 since it causes moderate skin sensitisation in guinea pigs. No further details are provided.
Results of First Challenge:
All animals of control group 1 and 18 of 20 animals of the test group did not show any skin reactions after the first challenge with 15% (weight/weight) test item in diglyme. Two animals of the test group (animals no.16 and no. 19) showed discrete or patchy erythema at the 48-hour reading after the first challenge with 15% test item in diglyme. One animal of control group 1 (animal no.12) and one animal of the test group (animal no. 19) showed discrete or patchy erythema at the 48-hour reading after the first challenge with 5% test item in diglyme and another animal of the test group (animal no. 32) showed discrete or patchy erythema at the 24-hour as well as at 48-hour reading after the first challenge with 5% test item in diglyme.
Results of Second Challenge:
One animal (animal no. 19) of the test group showed discrete or patchy erythema at the 48-hour reading after the challenge with 15% (weight/weight) test item in diglyme and one animal of the test group (animal no. 14) showed discrete or patchy erythema at the 24-hour reading after the challenge with 5% (weight/weight) test item in diglyme. No skin reactions occurred in the control groups.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on study conducted according to OECD Test Guideline 406 (non-LLNA, Buehler test) and in compliance with GLP (Harlan Laboratories Ltd., 2012, reliability score 1), triethoxy(3-thiocyanatopropyl)silane is concluded to be not sensitising in the male guinea pig when tested at 5 and 15% in diglyme under occlusive conditions for 6 hours. Induction was conducted once a week for 3 weeks, with the first challenge two weeks after the last induction dose. A separate second challenge was performed to further assess overall incidence. After the confirmatory second challenge, the overall incidence of test-item skin reactions was 10%.
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