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EC number: 404-170-0 | CAS number: 70750-63-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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: Comparable to guideline study with well documented report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- 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:
- Buehler test
- Justification for non-LLNA method:
- Study pre-dates the development of the LLNA test.
Test material
- Details on test material:
- - Physical state: Powder
- Lot/batch No.: Mix 51785
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld/West Germany
- Age at study initiation: Approximately 11 weeks
- Weight at study initiation: 349-446 grams
- Housing: Group housing of 2 animals per cage with wire-mesh floors
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid, LC 23-B, pellet diameter 4mm. Once weekley hay was provided.
- Water (e.g. ad libitum): Free access to tap -water, diluted with decalcified water.
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/-3C
- Humidity (%): 30-70%
- Air changes (per hr): 7.5-15
- Photoperiod (hrs dark / hrs light): 12 hours artifical fluorescent light/ 12 hours dark
IN-LIFE DATES: From: May 8, 1989 To: June 6, 1989
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% methyl cellulose
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: methylcellulose
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
50% (w/w) with 1% methylcellulose.
Nine topical applications were made, each of 6 hours duration, over a period of 3 weeks.
Concentration of test material and vehicle used for each challenge: 50% (w/w) in 1% methlcellulose, topically.
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: 1% methyl cellulose
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
50% (w/w) with 1% methlcellulose.
Nine topical applications were made, each of 6 hours duration, over a period of 3 weeks.
Concentration of test material and vehicle used for each challenge: 50% (w/w) in 1% methlcellulose, topically.
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Primary Irritaion
One animal treated with 50% (w/w) concetration of test material in 1% methyl cellulose for 24 hours and assessed for erythema at 24 and 48 hours.
Four animals treated with 50%, 25%, 10%, and 5% (w/w) concetration of the test material in 1% methyl cellulose for 6 hours and assessed for erythema at 24 and 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: nine
- Exposure period: 6 hours
- Test groups: test material 50% (w/w) with 1% methyl cellulose
- Control group: 1% methyl cellulose
- Frequency of applications: Days 1, 3, 5, 8, 10, 12, 15, 17, and 19
- Duration: 6 hours
- Concentrations: same throughout
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 29
- Exposure period: 6 hours
- Test groups: test article 50% in 1% methyl cellulose
- Control group: test article 50% in 1% methyl cellulose and 0.5ml of 1% methyl cellulose
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Control animals were challenged to 0.5ml of the test article: 50% (w/w) in 1% methyl cellulose and to 0.5 ml of 1% methyl cellulose.
- Positive control substance(s):
- yes
- Remarks:
- Formaldehyde
Results and discussion
- Positive control results:
- Formaldehyde was used as the positive control;
Concentrations selected for the study were
Induction- 0.5% (w/w) in milli-R0 water
Challenge- 0.5%, 0.25%, 0.1% (w/w) in milli-R0 water and milli-R0 water
Clearly positive results were observed in the experimental animals with a senstization rate of 68%, 63, %, 5%, and 0% for 0.5%, 0.25%, 0.1% and 0% respectively.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5 %
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.25 %
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 %
- No. with + reactions:
- 1
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
There were no signs of irritation noted in the primary irritation
experiments therfore Induction was set at 50% (w/w) in 1% methyl
cellulose. There were no signs of irritation observed at the end of the
induction phase and no
evidence of sensitisation of any challenge concentration.
Other observations:
No signs of toxicity or effects on body weight were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information not classified
- Conclusions:
- The test material resulted in a zero percent sensitization in the guinea pig. The test material is not classifed under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.
- Executive summary:
Under the conditions of the study, the t4est material lead to a sensitzation rate of 0 percent and is not classifed under EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) or by EC 1272/2008.
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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