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EC number: 401-270-6 | CAS number: 122390-99-2
- 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
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- - measurement of thickness of skin fold rather than observation of skin color
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- - measurement of thickness of skin fold rather than observation of skin color
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study has been conducted when the LLNA was not yet the standard method.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Versuchstieranstalt Winkelmann, Borchen, Kreis Paderborn
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 360 g (314 - 416 g)
- Housing: Makrolon-cages (type IV), on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3022, ad libitum
- Water (e.g. ad libitum): tap water in 2 750 mL plastic bottles, ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%): 50%
- Air changes (per hr): 10-fold/h
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light (artificial lightning)
IN-LIFE DATES: From: To: Nov. 04, 1986 to Dec. 12, 1986 - Route:
- intradermal
- Vehicle:
- other: Cremophor EL (2% v/v) in water for injection purposes
- Concentration / amount:
- - intradermal injection: 0.5%
- dermal application 25%, 25% and 10% - Route:
- other: dermal
- Vehicle:
- other: Cremophor EL (2% v/v) in water for injection purposes
- Concentration / amount:
- - intradermal injection: 0.5%
- dermal application 25%, 25% and 10% - No. of animals per dose:
- - test group: 20 animals
- 2 Control groups: 10 animals each - Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
- Executive summary:
A study was conducted to assess the sensitizing potential of the test substance in male guinea pigs (DHPW) according to EU Method B.6. and OECD guideline 406 in compliance with GLP.
Intradermal induction was performed using 25% test substance in Cremophor EL (2% v/v in water). Dermal induction and challenge treatment were carried out with 10% test substance in Cremophor EL (2% v/v in water).
The validity of the test system is confirmed by the periodically conducted positive control test using formaldehyde for the maximization test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
Reference
1. Auslösung (25%ige Prüfmusterformu1ierung)
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1.Kontrollgruppe |
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Prüfmusterseite |
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vor Behandl. |
48h |
72h |
48h |
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Hautfaltendicke in mm |
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M |
1.57 |
1.49 |
1.83 |
1.80 |
1.65 |
1.62 |
S |
0.14 |
0.13 |
0.11 |
0.13 |
0.10 |
0.11 |
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Prüfmustergruppe |
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Prüfmusterseite |
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vor Behandl. |
vor Behandl. |
48h |
72h |
48h |
72h |
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nach Behandlung |
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Hautfaltendicke in mm |
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|
|
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M |
1.58 |
1.49 |
1.85 |
1.84 |
1.61 |
1.58 |
S |
0.10 |
0.09 |
0.14 |
0.13 |
0.12 |
0.10 |
M =Mittelwert S=Standardabweichung Behandl.=Behandlung |
2. Auslösung (10%ige Prüfmusterformu1ierung)
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2.Kontrollgruppe |
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Prüfmusterseite |
Kontrollseite |
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vor Behandl. |
vor Behandl. |
48h |
72h |
48h |
72h |
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nach Behandlung |
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Hautfaltendicke in mm |
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|
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M |
1.53 |
1.52 |
1.66 |
1.63 |
1.57 |
1.56 |
S |
0.17 |
0.17 |
0.23 |
0.22 |
0.15 |
0.18 |
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Prüfmustergruppe |
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Prüfmusterseite |
Kontrollseite |
Prüfmusterseite |
Kontrollseite |
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vor Behandl. |
vor Behandl. |
48h |
72h |
48h |
72h |
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nach Behandlung |
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Hautfaltendicke in mm |
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|
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M |
1.71 |
1.69 |
1.89 |
1.96 |
1.73 |
1.76 |
S |
0.16 |
0.14 |
0.20 |
0.16 |
0.18 |
0.15 |
M =Mittelwert S=Standardabweichung Behandl.=Behandlung |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to assess the sensitizing potential of the test substance in male guinea pigs (DHPW) according to EU Method B.6. and OECD guideline 406 in compliance with GLP.
Intradermal induction was performed using 25% test substance in Cremophor EL (2% v/v in water). Dermal induction and challenge treatment were carried out with 10% test substance in Cremophor EL (2% v/v in water).
The validity of the test system is confirmed by the periodically conducted positive control test using formaldehyde for the maximization test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
Migrated from Short description of key information:
GLP guideline study according to OECD 406
Justification for selection of skin sensitisation endpoint:
GLP guideline study
Justification for classification or non-classification
In an GLP guideline study according to OECD 406, the test substance showed no evidence for sensitizing properties in guinea pigs.
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