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EC number: 209-136-7 | CAS number: 556-67-2
- 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
In the key reliability 1, guinea pig maximisation test (GMPT) conducted according to OECD 406 and GLP, D4 was not sensitising to the skin (Institut für Toxikologie der Bayer AG , 1985).
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:
- 23.07.1984 to 27.08.1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
- Species:
- guinea pig
- Strain:
- other: no data; albino
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co KG, D-4799 Borchen
- Age at study initiation: No data (may have been missed in translation)
- Weight at study initiation: 425-555 g
- Housing: Groups of 3, 4 or 5 in Makrolon Type IV cages
- Diet (e.g. ad libitum): 8 kg/week for 120 animals
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 45%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23.07.1984 To: 27.08.1984 - Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: 100 and 1%
Challenge: 100 and 10% - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: 100 and 1%
Challenge: 100 and 10% - No. of animals per dose:
- 20 test group
10 negative control - Details on study design:
- RANGE FINDING TESTS: Four formulations per animal (12.5, 25, 50 and 100%) were occlusively applied to the shaved flank skin (24 hours, each area approximately 2.5x2.5 cm). No further details could be translated.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two
- Exposure period: 48 hours
- Test groups: 1% intradermally (100% in 2nd induction epicutaneously) D4 in paraffin oil, 1% (100% in 2nd induction) D4 in FCA (50% in paraffin oil)
- Control group: FCA alone, paraffin oil alone, and paraffin oil with FCA
- Site: Flank
- Frequency of applications: Weekly
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: 24 hours
- Test and control groups: 100 and 10 % D4 in paraffin oil
- Site: Flank
- Concentrations: 100 and 10%
- Evaluation (hr after challenge): 48, 72 and 96 - Challenge controls:
- FCA in vehicle and vehicle alone.
- Positive control substance(s):
- no
- Positive control results:
- There was no positive control in this study.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% or 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: There was no positive control in this study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea-pig maximisation test (GMPT) conducted to OECD 406 and GLP (reliability score 1), D4 was not sensitising to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the key skin sensitisation study (GMPT) (Institut für Toxikologie der Bayer AG , 1985) albino guinea pigs were tested appropriately and in accordance with OECD test guideline 406, and to GLP. A preliminary test was conducted to determine irritancy and the concentrations to be used in the main study. Paraffin oil was used as the vehicle. In the main study 20 guinea pigs were tested with 1% D4 in paraffin oil in the first induction, and 100% D4 in the second induction. 100% and 10% (in paraffin oil) were used in the challenge phase under occlusive conditions. Ten negative control animals received the same treatment, but without D4. Evaluation of skin reactions were made at 48, 72 and 96 hours after challenge. Skin reactions in the test and control groups were all scored as zero, and therefore under the conditions of this study, D4 was not a skin sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available in vivo skin sensitisation data D4 does not require classification for sensitisation according toRegulation (EC) No. 1272/2008.
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