Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 434-440-3 | 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
Skin sensitisation (OECD 406): sensisiting
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:
- 5 May - 6 June 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Maximisation Test was performed prior to the amendment of Regulation (EC) No 1907/2006 in which the Local Lymph Node Assay is given as the first-choice in vivo study.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, UK
- Age at study initiation: approx. 4 - 7 weeks
- Weight at study initiation: 352 - 433 g
- Housing: 5 animals per cage in metal cages with wire mesh floors, hay was given thrice weekly
- Diet: vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -26
- Humidity (%): 37 -68
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 2.5%
- Day(s)/duration:
- single injection
- 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:
- 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- 37.5% and 50%
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (controls), 20 (test group)
- Details on study design:
- RANGE FINDING TESTS:
A range finding study was performed to determine the appropriate dose level of the test substance following intradermal and epicutaneous administrations. The intradermal and epicutaneous irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations of the test substance that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration by the epicutaneous route for the challenge phase. Animals were treated with an intradermal injection of 50% (v/v) FCA/water approximately 1 week prior to start of the range-finding study.
For the intradermal administration test substance concentrations of 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10% were injected intradermally in two animals each. Test substance concentrations of up to and including 2.5% caused irritation but did not adversely affect the animals.
For the epicutaneous administration test substance concentrations of 25, 50, 75 and 100% were applied to shaved skin of four animals. No skin reactions were observed up to and including 75% test substance concentration tested 24 and 48 h after removal of the patch. Erythema (score 1) was observed in 2/4 animals at 100% test substance concentration 24 and 48 h after removal of the patch.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture FCA/water
Injection 2: test substance in Alembicol D
Injection 3: test substance in a 1:1 mixture (v/v) of FCA and Alembicol D
Epicutaneous: undiluted test substance
- Control group:
Injection 1: a 1:1 mixture FCA/water
Injection 2: Alembicol D
Injection 3: a 1:1 mixture (v/v) of FCA and Alembicol D
Epicutaneous: Alembicol D
- Site: dorsal skin on the scapular region (intradermal + epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-7
- Concentrations: intradermal 2.5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: left anterior flank (75%) and left posterior flank (37.5%)
- Concentrations: 37.5 and 75%
- Evaluation: 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde, induction: intradermal 10%, epicutaneous 100%, challenge: 50 and 100%
- Positive control results:
- The positive control substance induced positive reactions (score 1 and 2) in 10/10 animals (100% first and second reading), thus meeting the reliability criteria for the Guinea Pig Maximisation Test (≥ 30% positive response). The positive control group was not carried out concurrently with this study but is a historical background data group from a study performed between 15 December 1997 and 8 January 1998.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 37.5 and 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 37.5%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 75%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Induction: 10%; challenge: 50 and 100%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 37.5 and 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 37.5%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 2.5%; challenge: 75%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Induction: 10%; challenge: 50 and 100%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Interpretation of results:
- other: Skin Sens. 1B (H317) according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the guinea pig maximisation test the test substance revealed sensitising properties at an intradermal induction dose of 2.5% in > 30% of the animals.
Reference
Intradermal induction:
Necrosis was recorded at sites receiving FCA in test and control animals. Slight to well-defined irriation (score 1 and 2) was seen in test animals at sites receiving either 2.5% (v/v) test substance in Alembicol D or Alembicol D alone.
Epicutaneous induction:
Slight to well-defined erythema (score 1 and 2) was observed in test animals following application with the undiluted test substance. Slight erythema (score 1) was seen in control animals.
Body weight:
Animals showed expected body weight gain during the study period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitising potential of the test substance was investigated in a guinea pig maximisation test (GPMT test) according to OECD Guideline 406 and in compliance with GLP (Coleman, 1998). A range finding study was performed to determine the appropriate dose level of the test substance in Alembicol D following intradermal and epicutaneous administrations. For the intradermal administration 7 concentrations of the test item (0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 7.5 and 10%) were injected intradermally in two animals each. Test substance concentrations of up to and including 2.5% caused irritation but did not adversely affect the animals. For the epicutaneous administration test substance concentrations of 25, 50, 75 and 100% were applied to shaved skin of four animals. No skin reactions were observed up to and including 75% test substance concentration tested 24 and 48 h after removal of the patch. Erythema (score 1) was observed in 2/4 animals at 100% test substance concentration 24 and 48 h after removal of the patch. Based on those results the following test substance concentrations were used: 2.5% for intradermal induction, 100% for epicutaneous induction and 37.5% and 75% for challenge exposure, respectively.
In the main study, 20 animals were used to investigate the skin sensitising potential of the test substance. In addition, 10 animals treated with Alembicol D only served as vehicle control. Necrosis was noted at test sites of animals receiving Freund´s Complete Adjuvant in test and control animals. In the first induction stage (intradermal injection), slight to well defined erythema (score 1 and 2) was observed in test animals receiving 2.5% (v/v) test substance in vehicle and in control animals receiving vehicle only. In second induction stage on Day 7 (epicutaneous), application of the undiluted test substance revealed slight to well-defined erythema (score 1 and 2) in test animals and application of vehicle revealed slight erythema (score 1) in control animals. The challenge with 37.5% (v/v) test substance revealed erythema in 10/20 animals of test group after 24 hours and in 8/20 test animals after 48 hours. The challenge with 75% (v/v) test substance revealed erythema in 14/20 animals of test group after 24 hours and in 13/20 test animals after 48 hours. Control animals did not show any skin reactions within 48 hours after challenge. Based on the results of this GPMT test, the test substance was regarded as a weak sensitizer under the conditions of the test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation meets the criteria for classification as Skin Sens 1B (H317) according to Regulation (EC) 1272/2008.
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.