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EC number: 500-336-2 | CAS number: 157348-58-8
- 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
Under the present test conditions, the test substance was not skin sensitising in a Buehler test according to OECD 406 (LPT, 2016).
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:
- 2016-06-09 to 2016-08-06
- 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 July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- published in the Official Journal of the European Union L142, dated May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- As the test item was found to be irritating to the mouse ear skin in the preliminary experiment, the (main) LLNA in mice was stopped prematurely.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley
- Sex: male
- Breeder: Charles River Laboratories, France
- Supplier: Charles River Laboratories, Research Models and Services Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age: 29 days
- Weight at study initiation: 301 - 365 g, positive control group: 273 - 337 g
- Housing: max 5 animals per cage
- Diet (e.g. ad libitum): Commercial diet ssniff7 Ms-H V2233 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany,
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days
- Controls: 10 animals; treatment: vehicle
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 55 +/- 15 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark rhythm - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 6 hour occlusive patch (left side), 0.5 ml undiluted; then removal of residual test material
- Day(s)/duration:
- day 1/8/15 for 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- two 6 hour occlusive patches (right side), one with 0.5 ml test substance (75%) and one with vehicle, subsequent removal of residual test material
- Day(s)/duration:
- day 29 for 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals control group
20 animals test material
20 animals positive control - Details on study design:
- RANGE FINDING TESTS:
A preliminary test was performed with 3 animals employing a range of concentrations of test item (as a 10, 25, 50 or 75% solutions in sesame oil or undiluted).
The flank regions of the animals were cleared of hair (closely-clipped) one day before application.
The test patch system, a square cotton pad of approximately 4 - 6 cm2, was fully loaded with 0.5 mL of the test item. The test patch system was applied to the test area and was held in contact with the skin by an occlusive patch and a suitable dressing for 6 hours. The test patch system was occlusive. The patch and the occlusive dressing were secured with adhesive strips (exposure time: 6 hours each).
For the main study for each induction stage, the concentration of test item was, if possible, adjusted to the highest level that could be well tolerated systemically and which, for irritant substances, produces mild to moderate irritation in the majority of test animals. The challenge concentration should be the maximum which produces no evidence of skin irritation in non-sensitised animals. No skin reactions were observed up to the concentration of 75%, the undiluted test item revealed a discrete or patchy erythema immediately and 24 hours after patch removal in this preliminary test.
Hence, the undiluted test item was chosen for the induction stages and a 75% concentration for the challenge of the main study.
ADMINISTRATION/EXPOSURE
- Induction - Topical application
Day 1 - Treated Group
One day before application the left side of the flank region of the animals were cleared of hair (closely-clipped).
The test patch system, a square cotton pad of approximately 4 - 6 cm2 was fully loaded with 0.5 mL test item, undiluted.
The test patch system was applied to the test area and was held in contact with the skin by an occlusive patch and a dressing for 6 hours. The test patch system was occlusive.
The patch and the occlusive dressing were secured with adhesive strips, exposure time: 6 hours each.
Day 1 - Control Group
One day before application the left side of the flank region of the animals were cleared of hair (closely-clipped).
The control animals were treated in a similar manner to that used for the treated group, but received sesame oil instead of test item.
The test patch system was applied to the test area and was held in contact with the skin by an occlusive patch and a suitable dressing for 6 hours.
Days 8 and 15 - treated and control groups
The same application as on day 1 was carried out on the same test area (cleared of hair one day before application) on the same flank region on day 8 and again on day 15.
- Challenge
Day 29 - Treated and Control Groups:
One day before application the untreated right flank of treated and control animals was cleared of hair (closely-clipped).
Two 6 hour occlusive patches (right side), one with 0.5 ml test substance (75%) and one with vehicle, subsequent removal of residual test material.
Skin observations and scoring: 24, 48 and 72 hours after removing of the patch the skin reaction was observed and recorded (Days 30, 31 and 32)
- Concentrations used for challenge: 75 %
- Positive control: alpha-hexylcinnamaldehyde (CAS No. 101-86-0) (not concurrent)
The animals of the positive control group were treated with 0.5 mL of undiluted a-hexyl cinnamaldehyde (HCA, 85%) on test days 1, 8 and 15 in the same manner as the animals of the negative control and the test item groups.
For the challenge on test day 29, HCA was used undiluted, too. The exposure time was 6 hours.
The sensitivity of the strain of guinea pigs employed is checked at regular intervals of approximately 6 months.
EXAMINATIONS
Skin observations and scoring
Days 30, 31 and 32: 24, 48 and 72 hours after removing of the patch the skin reaction was observed and recorded.
In addition, the skin condition was evaluated immediately and 18 hours after the end of induction exposures (6 and 24 hours after start of treatment).
- Grading system: Magnusson and Kligman, see below
OTHER OBSERVATIONS
Mortality: daily during the observation period
Clinical signs: daily during the observation period
Body weight: before the test commences and at study termination
Records were maintained on all additional and standard observations - Challenge controls:
- sesame oil
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde (CAS No. 101-86-0) (not concurrent) Bühler test with 20 test and 10 control animals Occlusive epicutaneous induction, undiluted Occlusive epicutaneous challenge with 50 % in corn oil
- Positive control results:
- The positive control a-hexyl cinnamaldehyde solution revealed sensitising properties in all 20 animals employed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Key result
- Reading:
- other: 3nd reading
- Hours after challenge:
- 78
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Key result
- Reading:
- other: 3nd reading
- Hours after challenge:
- 78
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Conclusions:
- Under the present test conditions, test item revealed no sensitising properties in guinea pigs in a skin sensitisation test according to E. V. BUEHLER.
- Executive summary:
The purpose of this study was to determine the sensitising potential of test item in a skin sensitisation test in guinea pigs according to E. V. BUEHLER. (Remark: As the test item was found to be irritating to the mouse ear skin in the preliminary experiment, the (main) LLNA in mice was stopped prematurely.)
The test item was used as supplied (100%) for the 3 induction stages and as a 75% concentration in sesame oil (v/v) for the challenge.
Sesame oil served as negative control.
The test item revealed discrete or patchy erythema (grade 1) or moderate and confluent erythema (grade 2) in all 3 induction stages.
A 75% concentration of the test item in sesame oil chosen for the challenge did not cause any skin reactions.
The positive control a-hexyl cinnamaldehyde solution revealed sensitising properties in all 20 animals employed.
Conclusion
Under the present test conditions, test item revealed no sensitising properties in guinea pigs in a skin sensitisation test according to E. V. BUEHLER.
Reference
RESULTS OF PILOT STUDY:
Four concentrations of test item dissolved in sesame oil (10, 25, 50 and 75%) and the undiluted test item (100%) were tested by dermal application to guinea pigs.
No skin reactions were observed up to the concentration of 75%, the undiluted test item revealed a discrete or patchy erythema immediately and 24 hours after patch removal in this preliminary test.
RESULTS OF TEST
Sesame oil served as negative control.
Test item revealed discrete or patchy erythema (grade 1) or moderate and confluent erythema (grade 2) in all 3 induction stages.
A 75% concentration of the test item in sesame oil chosen for the challenge did not cause any skin reactions.
The positive control a-hexyl cinnamaldehyde revealed pronounced sensitising properties.
No deaths or clinical signs were observed.
The body weight gain of the animals was not influenced.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
As the test item was found to be irritating to the mouse ear skin in the preliminary experiment, the LLNA in mice was stopped prematurely.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the skin sensitization test according to OECD 406 (Buehler method) in guinea pigs and according to the EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, the test substances has no skin sensitizing properties and hence it does not require to be classified.
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