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EC number: 470-180-7 | CAS number: 61196-40-5
- 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
According to the results of a Guinea Pig
Maximisation Test in compliance with OECD TG 406 the test item is considered
sensitising (reference 7.4.1 -1).
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:
- 2006-05-12 to 2006-06-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Based on the results of a pre-test, the test item was not sufficiently soluble in any of the vehicles applicable for an LLNA study. Therefore, an LLNA study was technically not feasible and a GPMT was conudcted instead. Furthermore, the in vivo assay OECD 406 was performed before the OECD 429 assay was mandatory.
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation: 318 g (range from 304 to 335 g)
- Housing: in type (3M15 (EBECO) Makrolon cages with a shelter and placed on mobile racks
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 22°C
- Humidity: 50 to 62%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- other: Sodium chloride solution (isotonic)
- Concentration / amount:
- 10 g/L
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sodium chloride solution (isotonic)
- Concentration / amount:
- 100 g/L
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sodium chloride solution (isotonic)
- Concentration / amount:
- 50 g/L
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pre Test Group: 5 females
Control Group: 5 females
Test Group: 10 females - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2x inductions
- Exposure period: induction by intradermal injection on day 1; induction by topical application on day 8 with an exposure for 48 hours
- Test groups: 1
- Control group: 1
- Site: cranial, medial, caudal
- Frequency of applications: 2 x induction
- Concentrations: 10 g/L intradermal; 100 g/L epidermal
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 hours occlusive
- Test groups: 1
- Control group: 1
- Site: cranial, medial, caudal
- Concentrations: 50 g/L epidermal
- Evaluation (hr after challenge): 48 and 72 hours - Positive control substance(s):
- yes
- Remarks:
- a-Hexylcinnamaldehyde (periodically tested)
- Positive control results:
- The sensitivity of the test system was checked and confirmed periodically.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 g/L
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the conditions of the maximization test, the test material exhibits a skin-sensitization potential.
- Executive summary:
The purpose of this GPMT assay conducted according to OECD TG 406 was to identify the contact allergenic potential of the test item. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man. The test item was evaluated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 5 Female guinea pigs in the negative control group (group 1) treated with the vehicle (sodium chloride solution) and 10 females in the test material group (group 2) were investigated. The induction included intradermal injection of test material preparation in sodium chloride solution (10 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application for 48 hours of test material preparation in sodium chloride solution (100 g/L) on experimental day 8. Challenge by topical application for 24 hours of the test material preparation in sodium chloride solution (50 g/L) was performed two weeks after topical induction and readings taken at 48 hours and 72 hours after start of treatment.
Challenge with 50 g/L test material revealed 7 of 10 animals (70 %) as positive responders. Under the conditions of the maximization test, the test material exhibits a skin-sensitization potential.
Reference
Table 1 (vehicle), indcution with sodium chloride solution
Animal No. |
Vehicle (caudal) |
Test material (cranial) |
||
|
48 hours* |
72 hours* |
48 hours* |
72 hour* |
86 |
0 |
0 |
0 |
0 |
87 |
0 |
0 |
0 |
0 |
88 |
0 |
0 |
0 |
0 |
89 |
0 |
0 |
0 |
0 |
90 |
0 |
0 |
0 |
0 |
*time after the start of the challenge
Table 2 (test material), induction with test item
Animal No. |
Vehicle (caudal) |
Test material (cranial) |
||
|
48 hours* |
72 hours* |
48 hours* |
72 hours* |
91 |
0 |
0 |
1 |
2 s |
92 |
0 |
0 |
1 |
1 s |
93 |
0 |
0 |
0 |
2 |
94 |
0 |
0 |
1 |
1 |
95 |
0 |
0 |
0 |
2 |
96 |
0 |
0 |
0 |
0 |
97 |
0 |
0 |
0 |
0 |
98 |
0 |
0 |
1 |
3 s |
99 |
0 |
0 |
0 |
0 |
100 |
0 |
0 |
1 |
1 |
*time after the start og the challenge
Rating scheme according to Magnusson & Kligman.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
GPMT
The purpose of this GPMT assay conducted according to OECD TG 406 was to identify the contact allergenic potential of the test item. This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man. The test item was evaluated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 5 Female guinea pigs in the negative control group (group 1) treated with the vehicle (sodium chloride solution) and 10 females in the test material group (group 2) were investigated. The induction included intradermal injection of test material preparation in sodium chloride solution (10 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application for 48 hours of test material preparation in sodium chloride solution (100 g/L) on experimental day 8. Challenge by topical application for 24 hours of the test material preparation in sodium chloride solution (50 g/L) was performed two weeks after topical induction and readings taken at 48 hours and 72 hours after start of treatment. Challenge with 50 g/L test material revealed 7 of 10 animals (70 %) as positive responders. Under the conditions of the maximization test, the test material exhibits a skin-sensitization potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin sensitisation, the test item is classified and
labelled as skin sensitiser Cat. 1 (H317: " May cause an allergic skin
reaction") according to Regulation (EC) No 1272/2008 (CLP), as amended
for the twelfth time in Regulation (EU) 2019/521.
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