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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-976-6 | CAS number: 2589-57-3
- 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
one Guideline study available sufficient for conclusion on the endpoint skin sensitisation.
An additional study conducted with a decomposition product of the substance is available as well.
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:
- 20-12-1999 - 30-03-2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted before adoption of LLNA method (OECD 429).
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2766
- Expiration date of the lot/batch:07 December 2000
- Purity test date: not stated
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in freezer in the darik
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: solubility tested in pretest and found suitable. stability not indicated
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not stated
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Preparation of formulation within 4 hours prior each tratment. No adustment was made for specific gravity of vehicle. Homogeneity was obtained to visually acceptable levels - Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Füllnisdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: approx. 4 weeks
- Weight at study initiation:< 500 g
- Housing: group housing of 5 animals
- Diet (e.g. ad libitum): Free access to standard guinea pig diet
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
- Indication of any skin lesions: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Day(s)/duration:
- Day 8: 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50 %test substance concentration
- Day(s)/duration:
- Starting on day 22, for 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
A preliminary irritation study was conducted in order to select test substance concentrations to be used in the main Study. The selection of concentrations was based on the following criteria:
-The concentrations are well-tolerated by the animals.
-For the induction exposures: the highest possible concentration that produced mild to
moderate irritation (grades 2・3).
-For challenge exposure: the maximum non-irritant concentration.
lntradermal iniections:
A series of four test substance concentrations was used, the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 ml/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment.
Epidermal application:
A series of four test substance concentrations was used, the highest concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape# which were held in place with Micropore tape# and subsequently Coban elastic bandage The animals receiving intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations.
After 24 hours, the dressing was removed and the skin cleaned of residual test substance using water.
The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48 h for epicutaneous exposure
- Test groups: 1
- Control group: 1
- Site: scapular area
- Frequency of applications: epicutaneous exposure 8 days after intradermal injections
- Duration: 21 days
- Concentrations: 5% intradermal, 50% epicutaneous
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressing
OTHER: - Challenge controls:
- vehicle only
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamic aldehyde
- Positive control results:
- The skin reactions in the experimental animals observed in response to the 10% ALPHA-HEXYLCINNAMICALDEHYDE, TECH. 85%
concentration in the challenge phase were considered indicative of sensitisation, taking into
account the intensity and persistence of the response in the control animals - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 18
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 18
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- not specified
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- not specified
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the conditions of the study, 7 of 18 animals of the test group showed positive responses to the challange exposure.
These results indicate a sensitisation rate of 39 per cent.
Based on these results and according to the Criteria lid down in (EC) No 1278/2008, the substance is classified for Skin sensitising Cat. 1 - Executive summary:
The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6,” Skin Sensitisation”and OECD No. 406,” Skin Sensitisation”, and based on the method described by Magnusson and Kligman,”Allergic Contact Dermatitis in the Guinea Pig -Identification of Contact Allergens".
Test substance concentrations selected for the main study were based on the results of a preliminary study and a toxicity test
In the main study, twenty experimental animals were intradermally injected with a 5% concentration and epidermally exposed to a 50% concentration. Ten control animals were similarly treated, but with vehicle alone (corn oil). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS.
Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.
Skin reactions of grade 1 were observed in seven experimental animals in response to the 50% test substance concentration.
No skin reactions were evident in the control animals.
Two animals were found dead on day 10 and 12 and signs of toxicity were observed on day 10.
Since the conclusion, based on the surviving animals, was not affected it was considered that this deviation had not affected the study integrity.
The skin reactions observed in response to a 50% test substance concentration in seven (of the eighteen) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.
Although toxicity was observed and two animals were found dead, it was considered that the test substance concentration could be tolerated by the animals and that the study outcome was not adversely affected.
These results indicate a sensitisation rate of 39 per cent.
Reference
Two animals of the test group died before Challange phase:
On day 10, one experimental animal was found dead and macroscopic post mortem
examination revealed no abnormalities.
On day 12, one experimental animal was found dead after showing lethargy and
ventro-lateral recumbence and macroscopic examination revealed small scabs in scapular area.
On day 10 Signs of toxicity (pale eyes, cold limbs, piloerection, lethargy and/or reduced mobility of the hind legs) were observed in the experimental animals.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
The presented substance is classified for skin sensitisation. The substance is not an Isocyanate and there are no structural alerts as mentioned in the flow chart (REACH technical guidance document IR/CSA: scheme of R.7a, Fig 7.3-2). Therefore, in a weight of evidence approach, the present information indicate no respiratory potential.
Justification for classification or non-classification
The available information is conclusive and sufficient for classifiaction as skin sensitising cat. 1.
The available information is conclusive but not sufficient for classification as respiratory sensitising.
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.