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EC number: 936-609-1 | 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted standards, well documented and acceptable for assessment. No data on purity of test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1966
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Thirty adults and twenty-three children were used in this study. The test material was applied to linteen discs approximately 0.5 square inches in diameter. These were then applied to the upper arms of the subjects and covered by an occlusive patch, being held in place with Blenderm Tape (3 M). After 24-hours the patch was removed and the reactions graded and recorded. A rest period of 24-hours then elapsed after which the patches were reapplied as before. This sequence was repeated until 15 successive patches had been applied. A two-week rest period was then allowed after which a challenge application was applied in a manner similar to the primary patches. In addition a control material consisting of Ivory soap, as a 1% w/v slurry in distilled water, was applied concurrently and in the same manner as the test material.
- GLP compliance:
- no
Test material
- Reference substance name:
- Irgacet Brown 2GL
- IUPAC Name:
- Irgacet Brown 2GL
- Details on test material:
- Purity: No data.
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed:
30 adults, 23 children - Clinical history:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: Repeated Insult Patch Test (RIPT)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: The test material was applied on linteen discs approximately 0.5 square inches in diameter. These were then applied to the upper arms of the subjects and covered by an occlusive patch, being held in place with Blenderm Tape (3 M).
- Vehicle / solvent: no data
- Concentrations: no data
- Volume applied: no data
- Testing/scoring schedule: After 24 h exposure the patch was removed and the reactions were scored. This sequence was repeated until 15 successive patches had been applied. A two-week rest period was then allowed after which a challenge application was applied in a manner similar to the primary patches. In addition a control material consisting of Ivory soap, as a 1% w/v slurry in distilled water, was applied concurrently and in the same manner as the test material.
- Removal of test substance: no data
EXAMINATIONS
- Grading/Scoring system:
0 = No reaction.
1+ = Slight erythema.
2+ = Marked erythema.
3+ = Marked erythema, edema, with or without a few vesicles.
4+= Marked erythema, edema, with vesicles and oozing.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed:
The test material produced reactions in 21 subjects of whom 9 subjects, 6 adults and 3 children, showed 2+ reactions
indicative of moderate fatiguing effects.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
Test substance:
- Number of subjects with positive reactions: 0/53
- Number of subjects with negative reactions: 53/53
- Number of subjects with irritating reactions while induction period: 21/53
Control substance (ivory soap):
- Number of subjects with positive reactions: 4/53
- Number of subjects with negative reactions: 49/53
- Number of subjects with irritating reactions while induction period: 31/53
RESULT OF STUDY:
Irgacet Brown 2GL was neither a primary irritant nor sensitizer to any of the test subjects under the test conditions. The test material is significantly less irritating than a 1% Ivory soap preparation under the same test conditions.
Insofar as sensitization is concerned, the significance of extrapolating these results to a general population is statistically limited by the number of the test subjects. From this test in which approximately 50 subjects were used, it may be predicted with a confidence of being correct in 19 out of 20 cases that Irgacet Brown 2GL will be safe to use by 90 out of every 100 people under conditions not exceeding those of this test in severity.
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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