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Diss Factsheets
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EC number: 460-380-2 | CAS number: -
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD/EU Guideline study performed under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The present guinea pig maximisation test is availabel and was conducted before requirements for LLNA applied.
As the study is reliable and applicable, it is considered that no further testing (LLNA) is needed. - Species:
- guinea pig
- Strain:
- other: Ibm: GOHI, synonym: Himalayan spotted
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrassse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 4 - 7 weeks
- Weight at study initiation: 398 - 433 g
- Housing: individually
- Diet (e.g. ad libitum): pelleted standard provimi kliba 3418, buinea pig breeding / maintenance diet, containing Vitamin C, ad libitum
- Water (e.g. ad libitum): community tab water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Intredermal injections: 100 % Test item in vehicle
Epidermal Application: 100 % Test item in vehicle
Challange Application: 1 % Test item in vehicle - Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Concentration / amount:
- Intredermal injections: 100 % Test item in vehicle
Epidermal Application: 100 % Test item in vehicle
Challange Application: 1 % Test item in vehicle - No. of animals per dose:
- not applicable
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: intradermal: day 1 - 7, Epidermal: day 8 - 26
- Test groups: all
- Control groups: all
- Site: scapular region (appr. 6*8 cm2)
- Frequency of applications: once
- Duration: epidermal exposure: 48 hours
- Concentrations: see respective entry
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27
- Exposure period: 24 hours
- Test groups: all
- Control group: all
- Site: left and right flank (appr. 5*5 cm2)
- Concentrations: see respective entry, right flank: vehicle only
- Evaluation (hr after challenge): 24 and 48 hours after removal - Challenge controls:
- vehicle only
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
- Positive control results:
- historical data (performed from 18-Feb-2002 to 02-April-2002): valid results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % (w/w)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % (w/w)
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % in PEG 300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % in PEG300
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the above mentioned findings in an adjuvant sensitization test (M&K-test) in guinea pigs, SALACOS HCISV-L does not have to be treated
as a skin sensitizer. - Executive summary:
In order to assess the cutaneous allergenic potential of SALACOS HCISV-L, the Maximization-Test was performed in 15 (10 test and 5 control) male albino guinea pigs, in accordance with OECD Guideline No. 406 and the Directive 96/54/EEC, 8.6. The intradermal induction of sensitization in the test group was performed in the nuchal region with the undiluted the test item and an emulsion of Freund's Complete Adjuvant (FCA) I physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the undiluted test item one week after the intradermal induction. The animals of the control group were intradermally induced with PEG 300 and FCA/physiological saline and epidermally induced with PEG 300 under occlusion. Nineteen days after epidermal induction the control and test animals were challenged by epidermal application of the test item at 1 % in PEG 300 and PEG 300 alone under occlusive dressing. Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
Results
Skin Reactions after the Challenge Procedure
after 24 hours
after 48 hours
positive / total
positive / total
CCONTROL GROUP
SALACOS HCISV-L, 1 % in PEG 300 (left flank)
0/5
0/5
PEG 300 only (right flank)
0/5
0/5
TEST GROUP
SALACOS HCISV-L, 1 % in PEG 300 (left flank)
0/10
0/10
PEG 300 only (right flank)
0/10
0/10
No toxic symptoms were evident in the guinea pigs of the control or test group.
No deaths occurred.
None of the control and test animals showed skin reactions after the challenge treatment with SALACOS HCISV-L at 1 % (w/w) in PEG 300.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Migrated from Short description of key information:
One in vivo Study available showing no signs of sensitising properties of the substance
Justification for selection of skin sensitisation endpoint:
Only one study available. This study is well performed and rated reliable.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
The presented substance has no indication for skin sensitisation and is therefore not a respiratory sensitiser either (REACH technical guidance document on information requirements and chemical safety assessment: scheme of R.7a, Fig 7.3-2). In addition, the substance has a low volatility (vapour pressure < 0.01 kPa).
Justification for selection of respiratory sensitisation endpoint:
No Study available and Information not requested by REACH.
Justification for classification or non-classification
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.