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EC number: 613-099-6 | CAS number: 62889-66-1
- 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
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Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Batch No.: Part 704, tank 328
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Designation: Pirbright White, Dunkin, Hartley HOE DHPK (SPF-LAC) guinea pig
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, OW-4923 Extertal 1, Germany
- Housing: Makrolon, type IV, 5 animals per cage
- Body weight at the beginning of the study: 278-328 g
- Diet: Kliba 341, 4 mm (rabbit-guinea pig-feed) ad libitum
- Water: ad libitum; tap water; about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 0.1 ml solution with 5% test substance
Percutaneous induction: 0.3 g formulation with 25% test substance
Challenge: 0.15 g formulation with 10% test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 0.1 ml solution with 5% test substance
Percutaneous induction: 0.3 g formulation with 25% test substance
Challenge: 0.15 g formulation with 10% test substance
- No. of animals per dose:
- 10 (Test group)/ 5 (Control groups)
- Details on study design:
- RANGE FINDING TEST:
Amount applied :
2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing. In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance formulation.
Exposure period:
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitisation reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application :
- Flank, respective on the same area
Number of test animals :
- 4 per test concentration
Readings :
- About 24 and 48 h after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
- No. of exposures: 2
- Test groups: 1: A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0 .9% aqueous NaCl-solution in a ratio of 1:1 B) middle row : 2 injections each of 0.1 ml of the test substance formulation (5% in olive oil) C) back row: 2 injections each of 0.1 ml 5% test substance in A)
- Control group: 2: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site: Shoulder
- Frequency of applications: once
- Duration: 7 days (reading after 24 h)
Percutan:
- No. of exposures: 1
- Test group: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing. In the case of liquids the filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance in olive oil (25%).
- Control groups: Both control groups were treated analogously to the test group but only with the solvent without the test substance
- Site: Shoulder
- Frequency of applications: once
- Duration: 48 h
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Days of challenge: 21 (after intradermal induction)
- Exposure period: 24 h
- Test group: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing. In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance in olive oil (10%).
Challenge :
- Treatment of the test group with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle.
- Control group: 2: control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle. Control group 2 only received olive oil DAB 9 .
- Site: flank
- Evaluation (h after challenge): 24 and 48 h after removal of the patch
- Challenge controls:
- yes, (control group 2)
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitro-benzol
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% in olive oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% in olive oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in olive oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in olive oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- edema and erythema of varying degree
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: edema and erythema of varying degree.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Negative control group 1
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Negative control group 1
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Negative control group 2
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Negative control group 2
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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