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EC number: 247-744-4 | CAS number: 26495-91-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 12 - April 27, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A LLNA study does not need to be conducted because adequate data from a OECD 406 skin senitisation study are available.
Test material
- Reference substance name:
- -
- EC Number:
- 454-780-6
- EC Name:
- -
- Cas Number:
- 27445-54-1
- Molecular formula:
- Hill formula: C12H27NO2Si CAS formula: C12H27NO2Si
- IUPAC Name:
- Cyclohexyl-((diethoxy-methyl-silanyl)-methyl)-amine
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc : DH - guinea pigs (Full-Barrier)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
10/5 (test/control) Hsd Poc : DH - guinea pigs (Full-Barrier) , Sex: female, bodyweight at the commencement of the study 300 - 500 g.
5 (range finding) Hsd Poc : DH - guinea pigs (Full-Barrier) , Sex: female, nulliparous, nonpregnant, bodyweight at the commencement of the study 300 - 500 g.
A health inspection was performed to ensure the good state of health of the animals. The animals were derived from a controlled full barrier maintained breeding system (SPF). Source: Harlan Winkelmann GmbH, D-33178 Borchen.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
ANIMAL HUSBANDRY
The animals were barrier maintained (semi-barrier) in an air conditioned room
Temperature: 22 +/- 3°C
ReI. humidity: 55 +/- 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Feeding ad libitum, Altromin 3122 maintenance diet for guineapigs, rich in crude fiber, totally-pathogen-free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
The animals were kept in groups in Terluran - cages on Altromin sawfiber bedding
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 0.5 % / 0.1 mL
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 2 days
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No. of animals per dose:
- 10
- Details on study design:
- Induction: First Stage, Intradermal Injection
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair by clipping so that one of each pair lies on each side of the midline.
Test group: Day 0
Injection 1: Freund's Adjuvant complete, 1 + 1 (v/v) diluted with isotonic saline
Injection 2: Prepared Test item
Injection 3: Prepared Test item at a concentration of 50% (VN) in Freund's Adjuvant complete, 1 + 1 (v/v) diluted with isotonic saline
Control group : Day 0
Injection 1: Freund's Adjuvant complete, 1 + 1 (v/v) diluted with isotonic saline
Injection 2: Vehicle
Injection 3: Vehicle at a concentration of50% (VN) in Freund's Adjuvant complete, 1 + 1 (v/v) diluted with isotonic saline
Injections 1 and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.
Induction: Second Stage, Topical Application
Test and Control Group: Day 6
Approximately twenty-four hours before the topical induction application the test area, after close clipping was painted with 0.5 ml of 10% sodium lauryl sulphate in vaseline, in order to create a local irritation.
Test Group: Day 7
A patch was loaded with 0.5 ml of the test item, applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control Group: Day 7
A patch was loaded with 0.5 ml of the vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.
Challenge: Topical Application
Test and Control Group: Day 20
A patch loaded with 0.5 ml of the test item was applied to the left flank of the animals and, a patch loaded with 0.5 ml vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours.
Observation
Test and Control Group
Approximately 21 hours after removing the patch the challenge area was cleaned and cleared of hair. Approximately 24 hours after removing of the patch the skin reaction was observed and recorded according to the grades shown below. Two more observations were recorded 48 and 72 hours after patch removal.
Additionally all animals have been observed for signs of toxicity at least once daily during the test period. - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole (15% in Vaseline)
Results and discussion
- Positive control results:
- The sensitization rate after application of the positive control substance Mercaptobenzothiazole (15% in Vaseline) was 80 %, confirming the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no treatment related effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no treatment related effects observed
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15 % in vaseline
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15 % in vaseline
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the reported data of this sensitization test it can be stated that the test item caused no reactions identified as sensitization.
- Executive summary:
A skin sensitization test according to OECD 406 was performed. Considering the reported data of this sensitization test it can be stated that the test item caused no reactions identified as sensitization.
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