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EC number: 434-230-1 | CAS number: 144413-22-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 July 1998 and 29 August 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): ARAKAWA KE-604
- Physical state: pale yellow blocks
- Analytical purity: no data
- Lot/batch No.: R61132
- Storage condition of test material: room temperature in the dark
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Ltd, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 313-426 g
- Housing: singly or in pairs in polypropylene cages with woodflakes bedding
- Diet (e.g. ad libitum): Guinea Pig FD1 Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water (e.g. ad libitum): mains tap water
- Acclimation period:at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 49 - 62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 1 % w/v in arachis oil BP, 1% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
Topical induction: 50 % w/w in arachis oil BP
Topical challenge: 50 % and 25 % w/w in arachis oil BP
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal induction: 1 % w/v in arachis oil BP, 1% w/v in a mixture of Freund's Complete Adjuvant plus distilled water
Topical induction: 50 % w/w in arachis oil BP
Topical challenge: 50 % and 25 % w/w in arachis oil BP
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
Sighting tests were performed for the selection of concentrations for intradermal induction, epicutaneous induction and epicutaneous challenge using a total of 6 guinea pigs. These animals did not form part of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: single intradermal injection on Day 0 and single topical application on the same skin area of the shoulder region on Day 7 for 48 h under occlusive dressing
- Test groups: 10 animals
- Control group: 5 animals
- Site: shoulder region
- Concentrations: Intradermal induction: 1 % w/v in arachis oil BP; topical induction: 50 % w/w in arachis oil BP.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 hours under occlusive dressing
- Test groups: 10 animals
- Control group: 5 animals
- Site: right flank region
- Concentrations: Topical challenge: 50 % and 25 % w/w in arachis oil BP
- Evaluation (hr after challenge): 24 and 48 hours after challenge dressing removal. - Challenge controls:
- 5 animals topically challenged with 50 % and 25 % w/w test substance in arachis oil BP
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole, 2,4 Dinitrochlorobenzene
Results and discussion
- Positive control results:
- Historical positive control (performed approximately every six month) resulted in sensitisation incidences of 70 - 100 % (between 7 and 10 out of 10 animals).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 and 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no other reactions noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no other reactions noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 and 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no other reactions noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no other reactions noted.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 and 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no other reactions noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no other reactions noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 and 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no other reactions noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 and 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no other reactions noted.
Any other information on results incl. tables
Table 1: Skin reactions observed after topical challenge with 25 and 50 % ARAKAWA KE-604 in arachis oil BP in guinea pigs
Animal group |
Challenge concentration of test material |
Observation time [h] |
Number of animals with skin responses (Scale 0-3) |
Sensitisation Incidence |
|||
0 |
1 |
2 |
3 |
||||
Test |
25 % (w/w) |
24 |
10 |
0 |
0 |
0 |
0/10 |
48 |
10 |
0 |
0 |
0 |
|||
Control |
24 |
5 |
0 |
0 |
0 |
||
48 |
5 |
0 |
0 |
0 |
|||
Test |
50 % (w/w) |
24 |
10 |
0 |
0 |
0 |
0/10 |
48 |
10 |
0 |
0 |
0 |
|||
Control |
24 |
5 |
0 |
0 |
0 |
||
48 |
5 |
0 |
0 |
0 |
Summary:
In a dermal sensitisation study 20 guinea pigs were tested according to the method of Magnusson and Kligman (OECD Guideline 406).Skin reactions were assessed 24 and 48 hours after topical challenge with 25 and 50 % of the test substanceARAKAWA KE-604in arachis oil.
No oedema or erythema formation was noted at any observation interval in all tested animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information No classification is required according to EU classification criteria.
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