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EC number: 627-023-4 | CAS number: 2441-41-0
- 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

Endpoint summary
Administrative data
Description of key information
In view of these results, under these experimental conditions, the test item LCA08002 must not be classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No Symbol and risk phrase are required.
In accordance with the GHS (COM(2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required.
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:
- 2008-05-12 to 2008-06-12
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed in 2008.
LLNA method (OECD 442 B) was adopted in 2010. - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69592 L'Arbresle)
- Age at study initiation: 4 weeks
- Weight at study initiation: 226g to 270g
- Housing: 2 or 3 animals/cage: polycarbonate containers
- Diet (e.g. ad libitum): C17.50 guinea pig breeder (SDS)
- Water (e.g. ad libitum): tap water from public distribution system
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 22°C
- Humidity (%): 44% to 61%
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12h/12h - Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Remarks:
- and liquid parrafin for topical application
- Concentration / amount:
- Intradermal induction: 25%
Topical induction: 60%
Topical Challenge: 30%
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Remarks:
- and liquid parrafin for topical application
- Concentration / amount:
- Intradermal induction: 25%
Topical induction: 60%
Topical Challenge: 30%
- No. of animals per dose:
- 10 animals
- Details on study design:
- 1-Preliminary studies:
1-1 Determination by intradermal injection of the Maximal Non Necrotizing Concentration (MNNC)
This test was conduced for the purpose of defining a MNNC of the test item which, on intradermic injection during the induction phase, does not risk causing too great lesion (non-necrotizing concentration), should be well-tolerated systemically and should be the highest to cause mild to moderate skin irritation.
Two animals received on both sides of the spine, a volume of 0.1mL of the test item, at 6 concentrations (25%; 12.5%; 6.25%; 3.125%; 1.56%; 0.78%) in olive oil.
A macroscopic evaluation of the cutaneous reactions was conducted 24 hours later and 48 hours later if necessary.
1-2 Dertermination by topical application of the pre-maximal non irritant concentration (Pre-MNIC):
This test, which allowed to evaluate the irritant potential of the test item, defined whether an application of sodium lauryl sulfate would be needed during topical induction phase.
The test item was applied on the dorso-lumbar zone of two guinea pigs shorn beforehand, with occlusive dressing for 24 hours, at 4 different concentrations: diluted at 60%, 30%, 15% and 7.5% in liquid paraffin.
A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the dressing
1-3 Dertermination by topical application of the maximal non irritant concentration (MNIC):
This test was carried out for the purpose of determining the MNIC of the test item wihtou risk of an irritant effect during the challenge phase.
Three guinea pig were treated according to the same treatment as animals from Group 1 (negative control) for the induction phase (i.e. Olive oil and liquid paraffin) of the main study.
During the challenge phase, the animals were treated with the test item placed onto the select treatment sites and covered with an occlusive dressing for a period of 24 hours at 4 different concentrations; diluted at 60%, 30%, 15%, 7.5% in liquid paraffin.
A macroscopic evaluation of the cutaneous reactions was conducted 24 hours after removal of the dressing
2-Main study
Group1: Negative control: 5 females
Group 2: treated: 10 females
2-1 induction phase:
2-1-1 intradermal induction
After shearing scapular zone, three pairs of intradermal injections of 0.1mL were performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine as follow:
Group1:
- 2 ID: Freund's Complete Adjuvant diluted at 50% in isotonic sodium chloride
- 2ID: Olive Oil
- 2 ID: a mixture with equal volume v/v: Freund's Complete Adjuvant at 50% and Olive oil
Group 2:
- 2 ID: Freund's Complete Adjuvant diluted at 50% in isotonic sodium chloride
- 2ID: test item at 25%
- 2 ID: a mixture with equal volume v/v: Freund's Complete Adjuvant at 50% and the test item at 50%
2-1-2 Topical induction:
Day6:
The scapular zone of all animals in each group, shorn beforehand, was brushed with a solution of SDS at 10% in thick vaseline, in order to create a local irritation.
Day 7:
A topical application under occlusive dressing for 48hours was performed on the injection sites of each animals.
Group 1: 0.5mL of liquid paraffin
Group 2: 0.5mL of the test item at 60% in liquid paraffin
2-2 rest phase:
The animals both groups were left for 10 days.
2-3 challenge phase:
Day 20
The experimental procedure of this phase was identicalfor both groups submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing was performed during 24 hours; 1 sample cup containing the test item at 60% (MNIC) and at 30% (1/2 MNIC) - Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
- Positive control results:
- 3 tests : 2008-02-12 ; 2007-10-16 ; 2007-01-16.
In conclusion, in view of the results, under these experimental conditions, the substance alpha-Hexylcinnamaldehyde: must be classified R43 "may cause sensitization by skin contact" in accordance with the criteria for the classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. This substance must be characterised by the symbol "Xi" and the warning label"irritant".
In accordance with the GHS (COM(2007)355 final), the test item must be classified category 1 "skin sensitisation". The signal word "Warning" and hasard statement H317 "May cause an allergic skin reaction" are required. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no reaction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no reaction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 100 % of animals sensitized
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- 100 % of animals sensitized
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no reaction.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no reaction.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no reaction.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- 90 % of animals sensitized
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- 70 % of animals sensitized
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- In view of these results, under these experimental conditions, the test item LCA08002 must not be classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No Symbol and risk phrase are required.
In accordance with the GHS (COM(2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required. - Executive summary:
The aim of the study was to evaluate the possible allergic activity of the test item LCA08002 after intradermal injection and topical administration in guinea pig.
After induction (intradermal injection at 25% and topical application 60%) of 10 guinea pigs of treated group with the test item LCA08002 and a 10 days rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test item diluted at 60% and at 30% in liquid paraffin. The experimental protocol was established according to the OECD guideline n0406 dated July 17th, 1992 and the method B.6 of the E.E.C. n°96/54 dated July 30th,1996.
No macroscopic cutaneous reactions attibutable 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.
In conclusion, in view of these results, under these experimental conditions, the test item LCA08002 must not be classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No Symbol and risk phrase are required. In accordance with the GHS (COM(2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
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.

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