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EC number: 464-700-1 | CAS number: 607724-42-5
- 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
The test substance showed no evidence of sensitizing properties.
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:
- From Mar. 29, 2005 to Apr. 29, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study predates the LLNA method
- Specific details on test material used for the study:
- - pH-value in water: approx. 5.5
- Solubility in water: > 100 g/L
- Stability and homogeneity in the vehicle: is guaranteed for 8 d in deionized water by HPLC analysis - Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißlegg, Germany
- Weight at study initiation: 340 - 402 g (mean = 372 g)
- Housing: in transparent macrolon® cages (type IV) on soft wood granulate* in an air-conditioned room, 3 or 2 animals per cage
- Diet: ssniff® Ms-H (V 2233), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 50 ± 20 %
- Photoperiod: 12 h light / dark cycle
IN-LIFE DATES: From: Mar. 29, 2005 To: Apr. 29, 2005 - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% / 4 x 0.1 mL
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 8 / 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% / 0.5 mL
- Day(s)/duration:
- Day 22 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in control group: 5 - Details on study design:
- TEST PROCEDURE
The following preparations were used for the intradermal injections:
Control group
1.) 50% Freund´s Complete Adjuvant emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed immediately before use with an equal volume of deionized water.
2.) Deionized water (Vehicle)
3.) 50% Freund's Complete Adjuvant emulsion mixed with an equal volume of the vehicle
Treatment group
1.) 50% Freund's Complete Adjuvant emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed immediately before use with an equal volume of deionized water.
2.) 5% test substance in deionized water.
3.) 5% test substance in a 50% Freund's Complete Adjuvant emulsion
For the intradermal injections of the test substance in 50% Freund's adjuvant, test substance was dissolved in deionized water and then mixed with an equal volume of Freund's Original Adjuvant [percentages w/v].
For the dermal treatments, test substance was suspended in deionized water [percentages w/v]
MAIN TEST FOR THE SENSITIZING PROPERTIES
Chronological description of the test procedure indicating the day, at which procedure was carried out:
Study Day 1:
The body weight of the animals was determined. The guinea pigs were shaved mechanically over a dorsal area of 4 x 6 cm in the vicinity of the shoulders.
Intradermal induction treatment.
Two intradermal injections per animal of each preparation (i.e. 50% Freund's Adjuvants, 5% test substance in deionized water and 5% test substance in 50% Freund's Adjuvants) was given in the treatment group. The injection sites were all within a dorsal area of 2 x 4 cm. Likewise control group was given two intradermal injections per animal of each preparation (i.e. 50% Freund's Adjuvants, deionized water and equal volume of deionized water and 50% Freund's Adjuvants).
Study Day 2 - 7:
The administration area was examined for local tolerance. Systemic toxic effects were recorded, when apparent.
Study Day 8:
Dermal induction treatment.
An amount of 0.5 mL of the test substance preparation (treatment group) or the vehicle (control group) was administered to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The administration area was then kept under an occlusive bandage covered with an impermeable film and an elastic bandage for 48 h.
Treatment group: 25% test substance in deionized water
Control group: deionized water
Study Day 10:
Occlusive bandage was removed, irritant effects were recorded, when apparent.
Study Day 11 - 21:
No treatment of control or treatment group.
Test animals were kept under observation.
Study Day 22:
Dermal challenge treatment
One area of approximately 5 x 5 cm on the left flank was shaved mechanically.
An amount of 0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch. The administration area was then kept for 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
Treatment and control group (left flank): 25% test substance in deionized water
Study Day 23:
Occlusive bandage was removed. Any remnants of the test substance were carefully washed off with warm water.
Study Day 24:
Examination of the skin approximately 24 h after removal of the patches.
Study Day 25:
Examination of the skin approximately 48 h after removal of the patches.
Body weight of the test animals was determined. - Positive control substance(s):
- yes
- Remarks:
- (alpha-hexylcinnamaldehyde tested in another study)
- Positive control results:
- After the challenge treatment positive response was observed in 100% of the treated animals
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test substance showed no evidence of sensitizing properties.
- Executive summary:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP.
Based on the results of a preliminary study, 5 and 25% of test substance in deionized water were selected as intradermal and dermal induction doses. The highest non-irritating concentration used for challenge application was 25% test substance in deionized water. None of the animals of the test group showed skin reactions 24 and 48 h after removal of the bandage.
Under the test conditions, the test substance showed no evidence of sensitizing properties.
Reference
Main test:
Body weight gains and clinical signs: The body weight gains of the animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study
Intradermal induction treatment: Intradermal injections with Freund's Adjuvant (with and without test substance) of caused severe erythema and edema along with indurations and encrustations. The administration sites treated with test substance in deionized water showed well-defined erythema and edema and sporadically encrustations. Intradermal injections of the vehicle alone exhibited no signs of irritation. Due to these strong reactions of the skin, 10% sodium dodecylsulfate was not administered at Day 7
Dermal induction treatment: After the removal of the patches at Day 10, well-defined erythema and edema, indurated and encrusted skin as well as partly necrosis were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance alone caused well-defined erythema and edema. The administration sites treated with the vehicle alone showed no signs of irritation.
Dermal challenge treatment: No skin reactions were observed in the control and the treatment group 24 and 48 h after removal of the occlusive bandage.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. Based on the results of a preliminary study, 5 and 25% of test substance in deionized water were selected as intradermal and dermal induction doses. The highest non-irritating concentration used for challenge application was 25% test substance in deionized water. None of the animals of the test group showed skin reactions 24 and 48 h after removal of the bandage. Under the test conditions, the test substance showed no evidence of sensitizing properties (Ehling, 2005).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
Based on the results of a guinea pig maximization test, the test substance does not need to be classified for skin sensitisation potential according to the EU CLP criteria (EC 1272/2008) as well as EU Directive 67/548/EEC.
Respiratory sensitisation
No study available.
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