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Diss Factsheets
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EC number: 210-441-2 | CAS number: 615-66-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer-reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Allergic contact dermatitis from 2-chloro-p-phenylenediamine in a cream dye for eyelashes and eyebrows
- Author:
- Christer Hansson and Kirsten Thorneby-Andersson
- Year:
- 2 001
- Bibliographic source:
- Contact Dermatitis, 2001, 45, 235–236
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Allergic contact dermatitis from 2-chloro-p-phenylenediamine in a cream dye was evaluated on a 29- yr old woman.
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2-chloro-p-phenylenediamine
- EC Number:
- 210-441-2
- EC Name:
- 2-chloro-p-phenylenediamine
- Cas Number:
- 615-66-7
- Molecular formula:
- C6H7ClN2
- IUPAC Name:
- 2-chlorobenzene-1,4-diamine
- Details on test material:
- - Name of test material (as cited in study report): 2-chloro-p-phenylenediamine (2-chloro-PPD)
- Molecular formula (if other than submission substance): C6-H7-Cl-N2
- Molecular weight (if other than submission substance): 142.588 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-chloro-p-phenylenediamine (2-chloro-PPD)
- Molecular formula: C6-H7-Cl-N2
- Molecular weight: 142.588 g/mole
- Substance type: Organic
- Physical state: Solid
- Purity: No data available
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: 29-year
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
Challenge
- Route:
- other: no data
- Vehicle:
- petrolatum
- Concentration / amount:
- 1%
- No. of animals per dose:
- 1
- Details on study design:
- RANGE FINDING TESTS: No data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Several years
- Exposure period: Several years
- Test groups: 1
- Control group: 10
- Site: lashes and brows.
- Frequency of applications: No data available
- Duration: Several years
- Concentrations: 1%
B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups: No data available
- Control group: No data available
- Site: No data available
- Concentrations: No data available
- Evaluation (hr after challenge): No data available
OTHER: No data available - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 1
- Clinical observations:
- Intensely itchy dermatitis at the brows were observed
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1. PPD derivatives and metabolites tested (D3 readings)
Allergen |
Concentration |
Case no. 1 |
2-chloro-PPD |
1% |
+++ |
Cream dye |
As is |
++ |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (skin sensitising) based on CLP criteria
- Conclusions:
- 2-chloro-p-phenylenediamine (2-chloro-PPD) is skin sensitizing as a positive response is observed upon application to the brows of a 29 yr old lady.
- Executive summary:
Allergic contact dermatitis from 2-chloro-p-phenylenediamine in a cream dye was evaluated on a 29- yr old woman. She had used the same product for several years without any side-effects. The colour was semipermanent and applied only 4X a year. She had developed an intensely itchy dermatitis at her brows but not at her lashes, despite these having been coloured at the same time. After treatment with corticosteroids, the dermatitis disappeared within a week.
The case was patch tested with the European standard series and PPD derivatives used for hair colouring, as well as their own cream dyes and constitu ents, including chloro-PPD. At D3, she had a +++ reaction to chloro-PPD (1% pet.) and a ++reaction to the cream dye as is. She also had a + reaction to PPD but no reaction to the other derivatives or metabolites of PPD tested.
No further positive reactions were found at D7. 10 controls were negative to the chloro-PPD test.
According to the publication, the test material classifies as a skin sensitizer.
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