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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 457-320-2 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 May 2002-13 June 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted before the LLNA was adopted in 2002.
Test material
- Test material form:
- liquid: viscous
- Details on test material:
- red viscous liquid
batch number: MRD-02-375
expiry date: 30-April-2007
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley-derived albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, PA
- Age at study initiation: males approximately 7 weeks; females approximately 9 weeks
- Weight at study initiation: males 396-483 g; females 393-458 g
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Guinea Pig Chow ~5026 (purina Mills, Inc.), ad libitum
- Water (e.g. ad libitum): municipal tap water treated by reverse osmosis, ad libitum
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 36-77
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Concentration of test material used at induction: Intradermal injection: 5% w/w in mineral oil
and 5% w/w in Freund's complete adjuvant emulsion
Epicutaneous application: 25% in mineral oil
Concentration of test material and vehicle used for each challenge: Challenge application: 0.5% and 0.2% w/w in mineral oil. - Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Challenge application: 0.5% w/w in mineral oil.
- Adequacy of challenge:
- highest non-irritant concentration
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 0.2% w/w in mineral oil
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10/sex
Number of animals in negative control group: 5/sex - Details on study design:
- RANGE FINDING TESTS: Intradermal and topical range-finding studies were carried out in order to determine the concentrations to be used in the main studies.
MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL AND EPICUTANEOUS INDUCTION
- No. of exposures: 2 (1 intradermal and 1 epicutaneous)
- Exposure period: indefinite (intradermal); 48 hours (epicutaneous, occlusive cover)
- Test groups: 1
- Control group: yes
- Site: back
- Frequency of applications: single set of 6 injections (3 pairs) at day 0; single epicutaneous administration at day 8
- Duration: not applicable
- Concentrations: Injections 5% test substance in mineral oil or Freund's complete adjuvant emulsion; epicutaneous 25% test substance in mineral oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1 upon challenge and 1 upon rechallenge
- Day(s) of challenge: day 21 and day 28
- Exposure period: approximately 24 hours
- Test groups: 1
- Control group: yes
- Site: back
- Concentrations: 0.5% in mineral oil (challenge) and 0.2% in mineral oil (rechallenge)
- Evaluation (hr after challenge/rechallenge): approximately 24 and 48 - Challenge controls:
- 5/sex challenged with 0.5% in mineral oil; another group of 5/sex rechallenged with 0.2% in mineral oil (volume 0.3 ml in each case; occlusive cover). Evaluation after approximately 24 hours in each case.
- Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde; test not carried out concurrently with present study, but within 6 months. Induction at 5% in propylene glycol and challenge at 0.5% and 1% in propylene glycol.
Results and discussion
- Positive control results:
- A contact sensitization response was observed.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .5 %. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .5 %. No with. + reactions: 4.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.2 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: .5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: .2 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% w/v HCA in propylene glycol
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- edema, eschar, desquamation and/or superficial lightening
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% HCA in propylene glycol
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- edema, eschar, desquamation and/or superficial lightening
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5% HCA in propylene glycol
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- edema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.5% HCA in propylene glycol
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- edema and/or desquamation
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Maximum concentration not causing irritating effects in range finding intradermal injection test was 5% w/w in mineral oil. This was the highest concentration indicated under guidelines for the test; it produced no systemic toxicity and only localized reactions at the injection sites. In the range-finding epicutaneous study, concentrations of 1, 2.5, 5, 10, 25, 50, 75 and 100% were assessed. A concentration of 25% produced a mild to moderate [irritation] response; 0.5% apparently produced minimal irritation and was considered to be the "highest nonirritating concentration"; it was used as a challenge concentration.
Evidence of sensitization of each challenge concentration: Following challenge with 0.5% w/w test substance in mineral oil, dermal scores of 1 were noted in 6/20 animals at the 24-hour scoring interval. At the 48 hour scoring interval, dermal scores of 1 were noted in 4/20 animals. Dermal reactions in the remaining test and challenge control animals were limited to scores of 0 to +/- ("slight patchy erythema"; note this was seen in all of the challenge control animals at 24 hours). Group mean dermal scores were noted to be higher in the test animals as compared to the challenge control animals.
Following rechallenge with 0.2% w/w test substance in mineral oil, dermal reactions were limited to scores of 0 to +/- in all test and rechallenge control animals following the 24 and 48 hour scoring intervals.
Other observations: One rechallenge control animal was found dead on Day 9, but as the animal had been dosed with vehicle the death was not considered to be test-article related.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- In a GLP study conducted according to EPA OPPTS 870.2600, the substance was considered to be a weak skin sensitiser in a guinea pig maximisation test
- Executive summary:
In a GLP study conducted according to EPA OPPTS 870.2600, the substance was tested for dermal sensitisation potential in a guinea pig maximisation test. Briefly, animals (10/sex) were induced initially with intradermal injections of 5% in mineral oil and 5% in Freund's complete adjuvant emulsion and then, one week later, with topical administration of a concentration of 25% in mineral oil (under occlusive cover for 48 hours). After a rest period of two weeks, animals were challenged with topical administration of 0.5% in mineral oil. They were rechallenged after a further week with a concentration of 0.2% in mineral oil.
Upon challenge with 0.5% in mineral oil, 6/20 animals had dermal scores of 1 (slight, but confluent or moderate patchy erythema) after 24 hours, and only 4 animals retained this degree of redness after 48 hours. Dermal reactions in the remaining test and challenge control animals were limited to no or only "slight patchy erythema". There were no significant differences in reactions between treated and control animals upon rechallenge with 0.2% in mineral oil (at most only "slight patchy erythema" was seen, and this occurred in both test and rechallenge control animals).
In conclusion, the substance can be considered to be a weak skin sensitiser when tested in a guinea pig maximisation test.
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.
Aunque la ECHA ofrece una gran cantidad de material en su idioma, una parte de esta página está solo disponible en inglés. Más información sobre la política de multilingüismo de la ECHA.
Bienvenido a la página web de la ECHA. Este sitio no es plenamente compatible con Explorer 7 (y versiones anteriores). Por favor, actualice su Internet Explorer a una versión más reciente.
Esta web utiliza cookies para mejorar su experiencia de navegación en nuestros sitios web.
Más información sobre el uso de cookies.