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Diss Factsheets
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EC number: - | CAS number: -
- 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)
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 27 Jan 1997 - 7 Mar 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Repeated insult patch test (RIPT) with 100 subjects
- GLP compliance:
- not specified
Test material
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Remarks:
- consent in conformity with: 21 CFR Part 50: "Protection of Human Subject" was secured from each subject
- Subjects:
- - Number of subjects exposed:
- Sex: 29 male, 84 female
- Age: 18 - 65 years - Clinical history:
- - History of allergy or casuistics for study subject or populations: no subject had a history of any dermatological or other medical or physical condition which would preclude from topical testing
- Exposure history: a period of at least six weeks ahd elapsed since a subject was patched RIPT of Photoallergy Test before he was used in this RIPT - Controls:
- Not reported
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: webril/adhesive patch (Kendall Healthcare Products Company Patch #4022)
- Concentrations: 100%
- Volume applied: 0.2 mL was applied to each patch
- Test site: left scapular area for induction, right scapular area for challenge
- Testing/scoring schedule: nine induction patches (24 h each) within three weeks, followed by a apprx. two week rest period. The challenge consist of a 24 h patch scored 24, 48, 72 ahnd 96 h after after patching.
EXAMINATIONS
- Grading/Scoring system: modified scoring scale of the International Contact Dermatitis Research Group System: Fisher, Alexander a., Contact Dermatitis, Lea & Febiger, Philadelphia, 1986: p26:
0 - no visible reaction
± - faint, minimal erythema
1 - erythema
2 - intense erythema, induration
3 - intense erythema, induration, vesicles
4 - severe reaction with erythema, induration, (may be weeping) pustules
E - indicates edema
DR - dryness
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
A total of 98 of initial 113 subjects, 27 male and 71 female completed the study. 15 subjects discontinued the study, none of them due to test material reaction:
- Number of subjects with positive reactions: 0/98
- Number of subjects with negative reactions: 98/98
- Number of subjects with equivocal reactions: 0/98
- Number of subjects with irritating reactions: 0/98
During the induction phase, no reactions were exhibited.
The original tests sites exhibited no reactions during the rest period or challenge phase.
At the challenge, one subject exhibited a low-level (±) reaction.
Any other information on results incl. tables
Summary of reactions:
Reaction grade* | Induction Readings | Challenge Readings (h) | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 24 | 48 | 72 | 96 | |
0 | 106 | 105 | 103 | 101 | 101 | 100 | 99 | 99 | 99 | 97 | 98 | 96 | 94 |
± | 1 | ||||||||||||
1 | |||||||||||||
2 | |||||||||||||
3 | |||||||||||||
4 | |||||||||||||
- | 2 | 4 | |||||||||||
Number of subjects | 106 | 105 | 103 | 101 | 101 | 100 | 99 | 99 | 99 | 98 | 98 | 98 | 98 |
* Scoring system:
0: no visible reaction
±: faint, minimal erythema
1: erythema
2: intense erythema, induration
3: intense erythema, induration, vesicle
4: severe reaction with erythema, induration, (may be weeping) pustules
-: no site reading
Applicant's summary and conclusion
- Conclusions:
- Not sensitizing
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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