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EC number: 419-370-3 | CAS number: 84632-66-6
- 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
- Study period:
- 1995-01-04 to 1995-01-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 92/69/EEC, 31-Jul-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 317 - 427 g
- Housing: Individually in Makrolon type-3 cages with autoclaved standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 342, batch no. 66/94 guinea pig breeding/maintenance diet ("Kliba", Klingentalmuhie AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: One week for the control and test group under test conditions after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 51-68
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1994-12-28 To: 1995-01-30 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction:
intradermal: 5%
epidermal: 25%
Challenge:
epidermal: 25% - Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction:
intradermal: 5%
epidermal: 25%
Challenge:
epidermal: 25% - No. of animals per dose:
- Test group: 20
Control group: 10 - Details on study design:
- RANGE FINDING TESTS:
The objective of this investigation was to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main
study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
MAIN STUDY
A.1 INDUCTION EXPOSURE -intradermal
- No. of exposures: one, on test day 1
- Exposure period: single treatment
- Test groups (2 injections each):
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5% with ethanol.
3) The test article diluted to 5% by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group (2 injections each):
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) ethanol
3) 1:1 (w/w) mixture of ethanol in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Site: scapular region
- Concentration: 5 % in ethanol
A.2 INDUCTION EXPOSURE-epidermal
- No. of exposures: one
- Exposure period: start on test day 8 for 48 h
- Pretreatment: 10% Sodium-Lauryl-Sulfate (SLS)
- Test groups: 2 x 4 cm patch of filter paper was saturated with the test article (25% in ethanol)
- Control group: 2 x 4 cm patch of filter paper was saturated with the test vehicle (ethanol)
- Site: scapular area
- Concentration: 25 % in ethanol
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day of challenge: performed on test day 22
- Exposure period: 24 h
- Test groups: Two patches ( 2 x 2 cm) of filter paper were saturated with the highest non-irritating concentration of 25% (left flank) and the vehicle only (right flank)
- Control group: same as test group
- Site: flank
- Concentration: 25 % in ethanol
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- none
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazol and Benzocaine
- Positive control results:
- Following treatment (challenge) with 25% 2-Mercaptobenzothiazol or 25% Benzocaine in mineral oil 60% 60% of the animals were positive in the GPMT, indicating the sensitivity of the test system used for sensitisation assessment.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Procedure and results
To evaluate the allergic potential of the substance, a skin maximisation test in guinea-pig was perfomed. Ten test and ten control guinea-pigs were used in this study. For induction the animals were treated intradermally (5%). 6 days later, topical induction (25%) in the same area was performed after treatment with sodium lauryl sulphate in petrolatum. Control and test animals were challenged topically two weeks after the topical induction application using the test substance, 50% w/v in distilled water.
No skin reactions or signs of toxicity were recorded. There were no dermal reactions seen in any of the test animals.
Discussion
The test substance did not induce any dermal reactions in test animals. Thus, the test substance is considered to be a non-sensitizer.
Migrated from Short description of key information:
To evaluate the allergic potential of the test substance, a skin maximisation test (EU B.6, GLP) in guinea-pig was perfomed. The test item did not induce any dermal reactions in test animals. Thus, the test substance is considered to be a non-sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.
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