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EC number: 259-563-8 | CAS number: 55281-26-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 2 to July 5, 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Source study has reliability 1. Details on the read across are available in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A LLNA study was not conducted because adequate data from a Buehler test was already available.
Test material
- Reference substance name:
- Similar Substance 03
- IUPAC Name:
- Similar Substance 03
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Females nulliparous and non-pregnant: yes
- No. of animals for irritation screen: 4 F
- No. of animals for main study: 30 F; challenge: 20 test animals and 10 control animals
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 301 - 400 g
- Housing: individually in Makroion type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week for control and test group under test conditions after health examination. However, contrary to test group, control group remained untreated during the 3 induction weeks. One day for animals used in the irritation screen for induction and challenge.
- Indication of any skin lesions: only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40 - 70 %
- Air changes: 10 - 15 per h
- Photoperiod: 12 hr dark / 12 hr light
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- induction: 50 %
challenge: 50 %
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- induction: 50 %
challenge: 50 %
- No. of animals per dose:
- Challenge:
- 20 test animals
- 10 control animals
Irritation screen:
- 4 animals - Details on study design:
- IRRITATION SCREEN FOR INDUCTION AND CHALLENGE - PERF
Four guinea pigs were used. Four different concentrations were used on each animal for a 6-hour exposure period. Test article concentration of 50 % in bi-distilled water was considered to be the most qualified to assure an optimum technical application procedure.
The allocation of the different test dilutions to the sites (A, B, C, D) on the four animals was alternated in order to minimize site-to-site variation in responsiveness. Application sites were assessed for erythema and oedema 24 and approximately 48 hours after removal of the patches.
The highest test article concentration of 50 % in bi-distilled water was considered to be the most representative concentration to stimulate a state of immune hypersensitivity in the induction phase and the highest non-irritating concentration to be used for the challenge.
INDUCTION
Concentration of test article required for induction was agreed after the irritation screen had been completed. The fur was clipped from the left shoulder of each test animal and patches applied, over a period of 3 weeks. Each animal received one patch per week which remained in place for approximately 6 hours each. Repeated application was performed at the same site. Interval between exposure was one week. After the last induction exposure, animals were left untreated for 2 weeks before the challenge.
Skin responses were graded approximately 24 hours after patches have been removed. Any gross skin reactions were recorded without depilation.
CHALLENGE - PERFORMED ON TEST DAY 29
Animals previously exposed during the induction period (i.e. test group) as well as the previously untreated control animals were challenged two weeks after last induction exposure using the dose as prescribed. Fur was clipped from the left posterior quadrant of the side and back of the animals. Exposure period was 6 hours on a naive skin site. Responses were graded at 24 and 48 h after patches have been removed. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- 90 % of the animals of the test group were observed with significant skin reactions (grade of 0 and ± are considered to be non-significant responses, whereas those of 1 and greater are considered to be significant) after challenge performed with the highest nonirritating concentration of alpha-hexylcinnamaldehyde at 10 % in PEG 400.
No skin reactions were observed in the control group treated in the same conditions during the challenge phase.
Therefore, positive control applied at a concentration of 10 % in PEG 400 is considered to be a sensitizer when used under the described test conditions.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
Any other information on results incl. tables
VIABILITY / MORTALITY / MACROSCOPIC FINDINGS
There were no deaths during the course of the study, hence no necropsies were performed.
CLINICAL SIGNS, SYSTEMIC
No symptoms of systemic toxicity were observed in the animals.
SKIN EFFECT IN THE INDUCTION
As test article at 50 % in bi-distilled water stained the skin violet, it was not possible to determine whether erythema was present or not. However, no oedema was observed.
SKIN EFFECT IN THE CHALLENGE
Discrete/patchy erythema was observed in 8 (at the 24 -hour reading) and 4 (at the 48 - hour reading) out of 20 test animals after treatment with test article at 50 % in bi-distilled water. No skin reactions were observed in animals of the control group treated with same test article, vehicle and concentration.
BODY WEIGHTS
The body weight of animals was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- other: classified as Category 1B (indication of skin sensitising potential) based on CLP Regulation (EC 1272/2008)
- Conclusions:
- Skin sensitising.
- Executive summary:
Method
The skin sensitising potential of test substance was evaluated using a Buheler test, according to the OECD guideline 406.
Results
20 female animals of test group were treated topically with test substance at 50 % in bi-distilled water once a week for a 3 week induction phase. 2 weeks after the final induction application, animals were challenged with the same test article concentration of 50 % in bi-distilled water as used for induction. The 10 animals of the control group were not treated during the induction but were treated once at challenge with test substance at 50 % in bi-distilled water.
In this study, 40 % of animals in test group showed skin reactions after challenge treatment performed with the highest non-irritant concentration of test substance at 50 % in bi-distilled water. No skin reactions were observed in the control group treated in the same conditions during the challenge phase.
Under experimental conditions, the substance is considered as a skin sensitizer.
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