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Diss Factsheets
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EC number: 401-300-8 | CAS number: 86168-95-8
- 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
- Study period:
- 1985-05-28 to 1985-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 406: Maximisation test in the Guinea pig) under GLP-like quality assurance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- QAU-statement included
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Physical state: solid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Toxicology GU 2.5, CIBA-GEIGY AG Basel, Switzerland (bred on premises)
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 276 to 410 g
- Housing: Individually in Macrolon cages (type 3)
- Diet: ad libitum standard guinea pigs pellets (NAFAG No. 846, Gossau SG), supplemented with fresh carrots
- Water: fresh water ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Relative humidity: 50 ± 10%
- Photoperiod: 12 hours light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiological saline, sesame oil
- Concentration / amount:
- Intradermal Induction: 1% test item in sesame oil or phys. saline / CFA mixture
Epidermal Induction: 30% in vaseline approx. 0.4 g per patch
Epidermal Challenge: 10% in vaseline, approx. 0.2 g per patch
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiological saline, sesame oil
- Concentration / amount:
- Intradermal Induction: 1% test item in sesame oil or phys. saline / CFA mixture
Epidermal Induction: 30% in vaseline approx. 0.4 g per patch
Epidermal Challenge: 10% in vaseline, approx. 0.2 g per patch
- No. of animals per dose:
- Test item group: 10 males and 10 females
Control group: 10 males and 10 females - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Test groups: 20 animals (10 m/10 f)
- Control group: 20 animals (10 m/10 f)
First, two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. Concentration of the test compound was 1%. Control animals received the same pairs of injections but without the test article (vehicle only).
One week later the test substance was incorporated in vaseline at a concentration of 30% (0.4 g) and applied on a filter paper patch to the neck of the animals (occlusive administration for 48 hours). Control animals were treated with vaseline alone.
B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: two weeks after the epidermal induction
- Exposure period: 24 h occlusive application
- Site: on the flank of the guinea pig
- Concentrations: 10% test item in vaseline and the vehicle alone
- Evaluation: Twenty four hours after removing the dressings, the challenge reactions were graded according the Draize scoring scale
The concentrations of the test compound for induction and challenge periods were determined on separate animals. - Challenge controls:
- A control group of 20 animals (10 m/10 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period, the group was treated with the vehicle as well as with the test item to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- The sensitivity of the strain was controlled every six months with p - phenylenediamine (PPD).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
In a guinea pig maximization test according to OECD guideline No. 406, 10 male and 10 female animals were first induced and then challenged with the test article to investigate its sensitization potential. Induction was a two-stage operation: First, three pairs of intradermal injections (1 % test substance in sesame oil) were made into the neck of the animals with a 1:1 mixture (v/v) of FCA/ physiological saline, the test substance in sesame oil, and the test substance in a 1:1 mixture (v/v) of FCA/ physiological saline. One week later, the test article was incorporated in vaseline at a concentration of 30% and applied on a filter paper patch to the neck of the animals (occlusive administration for 48 hours). Two weeks after the epidermal induction application the animals were tested on the flank with 10% test substance in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. A control group (20 m/20 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals. No animal of the test group was sensitized by the test substance, all skin reactions at 24 and 48 hour time points were scored 0. Therefore, under the experimental conditions of this study, the test material is non-sensitizing when topically applied to albino guinea pigs.
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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