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EC number: 478-950-4 | 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
Not sensitising (OECD 406, GLP, K, rel.1).
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
- Study period:
- 20 March to 27 April 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD Guideline 406 with deviations: age at study initiation, housing and feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992.
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 96/54/E.C.
- Deviations:
- yes
- Remarks:
- age at study initiation, housing and feeding conditions not reported.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspected on 2005-10-03 / Signed on 2005-12-13.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to REACH regulation, in vivo skin sensitisation studies that were warried out or initiated before 10 May 2017 shall be considered appropriate to address this standard information requirement.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre de production Animale (F-45160 Olivet)
- Weight at study initiation: 348-498 g
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-23 °C
- Humidity: 28-53 %
IN-LIFE DATES: 20 March to 27 April 2006 - Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- intradermic injection at 3.125%
- Day(s)/duration:
- 8 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- topical application at 100%
- Day(s)/duration:
- 3 days
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- topical application at 100 and 50%
- Day(s)/duration:
- 3 days
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 males and 5 females for treated group
- Details on study design:
- PRELIMINARY TESTS:
Maximum Non Necrotizing Concentration (M.N.N.C.) determination: 2 male guinea pigs were used. The test item was injected by intradermal route at the following concentrations: 100%, diluted at 50%, 25%, 12.5%, 6.25% and 3.125% in olive oil. No necrosis has been observed, at the concentration of 3.125%, the first induction has been carried out by intradermal injection at the same concentration.
Pre-Maximum Non Irritant Concentration (Pre -M.N.I.C.) determination: 2 male guinea pigs were used. The test item was applied under an occlusive dressing during 24 hours, at the following concentrations 100%, diluted at 50%, 25% and 12.5% in paraffin oil. 24 hours after the removal of the occlusive dressings, no cutaneous reaction was recorded. In view of these results, the concentration selected was 100% for the 2nd induction of the main study and the MNIC determination began at this concentration of 100%.
Maximum Non Irritant Concentration (M.N.I.C.) determination: 3 female guinea pigs were used. After induction by intradermal injection with olive oil and by topical application with paraffin oil and a 17-day rest phase, the challenge phase under occlusive dressing for 24 hours consists in a single topical application of the test item at the following concentrations: 100%, diluted at 50%, 25% and 12.5% in paraffin oil. 24 hours after removal of the occlusive dressings, no cutaneous reaction was recorded. In view of this result, the concentrations selected were 100% (MNIC) and 50% (1/2 MNIC) for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE (INTRADERMAL - 1st induction: Day 0)
- No. of exposures: One
- 2 intradermal injections of the test item at 3.125%; 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in a physiological saline solution; 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the test item at 6.25%.
- Exposure period: Day 0-6
- Duration: 7 days
- Concentrations: 3.125% in olive oil
B. INDUCTION EXPOSURE (TOPICAL - 2nd induction: Day 7)
- No. of exposures: One
- Topical application, on the same zone, with the test item at 100%, 24 hours after brushing with 0.5 mL of a solution of Sodium lauryl sulfate at 10%.
- Duration: 3 days
- Concentrations: 100%
C. REST PHASE: 17 days
D. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 27
- Exposure period: 24 h
- Challenge phase (Groups 1 & 2): topical application under occlusive dressing at the following concentrations: 100% & 50%.
- Evaluation: 24 and 48 h after challenge - Challenge controls:
- No. of animals: 3 males and 2 females
Challenge: 100% and 50% - Positive control substance(s):
- yes
- Remarks:
- a-Hexylcinnamaldehyde
- Positive control results:
- Historical data: α-Hexylcinnamaldehyde at 25 or 50% induced skin sensitisation in more than 30% of the treated animals indicating the validity of the study.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 and 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Historical data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, test substance is not classified as sensitiser according to the criteria of the Regulation EC No. 1272/2008 (CLP) and of the GHS.
- Executive summary:
In a Magnusson & Kligman maximisation study (GPMT) performed according to OECD Guideline 406 and in compliance with GLP, Guinea pigs were treated as follows:
After induction (intradermic injection at 3.125% and topical application at 100%) of 10 Guinea Pigs of treated group with the test substance and a 17 -day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test item at 100% and diluted at 50% in paraffin oil. The test concentrations for the main study were determined from a preliminary study.
No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item. No cutaneous intolerance reaction was recorded in animals from the negative control group.
The sensitivity of the guinea-pig was checked with known sensitiser i.e., α-Hexylcinnamaldehyde indicating the validity of the study.
Under the test conditions, test substance is not classified as sensitiser according to the criteria of the Regulation EC No. 1272 /2008 (CLP) and of the GHS.
This study is considered as acceptable and satisfies the requirement for skin sensitisation endpoint.
Reference
Sensitising potential assessment: No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item. No cutaneous intolerance reaction was recorded in animals from the negative control group.
Weight evolution: No abnormality was recorded in the weight growth of both groups.
Mortality: No mortality occurred during this study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A key study was identified (Phycher, 2006). In this dermal sensitisation study performed according to the OECD guideline No. 406 and in compliance with GLP, the test material was tested in ten Guinea Pigs (5 males and 5 females) using the Magnusson and Kligman method (10 treated animals + 5 controls). The preliminary study determined the concentration to be used for the induction and challenge phases of the main study. The test material diluted in olive oil at 3.125% was administered by injection for intradermal induction. On Day 7, topical induction was performed with the test material as supplied, 24h after brushing with 0.5 mL of sodium lauryl sulfate at 10%. For the challenge, on Day 27, the test material was tested at 50 diluted in paraffin oil and at 100%.
The historical positive control α-Hexylcinnamaldehyde produced skin sensitisation. The test system was therefore considered to be valid.
In both groups, no clinical signs and no deaths were noted during the study. The body weight gain of the treated animals was similar to that of the control animals. After the challenge application, no cutaneous reaction was noted. The overall sensitisation rate was 0%.
Under the test conditions, the test material is not a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Based on the available data no additional self-classification is proposed according to the CLP and to the GHS.
No data was available for respiratory sensitisation. However, this substance is not a skin sensitizer, therefore according to Figure R.7.3 -2 of the Chapter R.7 (V 4.1 - October 2015) the chemical is not considered as a respiratory sensitiser.
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