Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-430-6 | CAS number: 95-54-5
- 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
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- publication
- Title:
- Method for assessment of experimental allergy in guinea pigs adapted to cosmetic ingredients
- Author:
- K G DOSSOU, C SlCARD, G KALOPISSIS, D REYMOND, H SCHAEFER
- Year:
- 1 985
- Bibliographic source:
- Contact Dermatitis 1985: 13: 226-234
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: company guidline for testing cometic ingredients
- Deviations:
- no
- Principles of method if other than guideline:
- Method 1: open epidermal induction and challenge, the intensity of the reaction being maximized by injecting Freund's complete adjuvant into the foot pad
Method 2: quasi-intradermal induction: both the adjuvant and test substance are injected into the foot pad - GLP compliance:
- not specified
- Type of study:
- other: modified guinea pig maximisation tests
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- purity >=99%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Acclimatization: 1 week.
Husbandry: in groups of 12 (6 M and 6 F) or 24 (12 M and 12 F). For each experiment, there were 3 groups: 1 control. 1 topical route. 1 intradermal route. When necessary, 2 vehicle groups were added.
Room temperature: (22±2)°C
Relative humidity: (55±15)%.
Ventilation frequency: 13 cycles/h.
Food: C17-50 pellet diet from Extrii Labo.
Water: available ad libitum.
Cages: iron cages (54 x 42 x 20 cm), 3 animals / cage
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: Method 1: induction by topical route, Method 2: Induction by injection
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.18 mmol/L
Challlenge: 0.09 mmol/L
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.18 mmol/L
Challlenge: 0.09 mmol/L
- No. of animals per dose:
- 12 (6 M and 6 F) or 24 (12 M and 12 F)
- Details on study design:
- For each experiment, there were 3 groups: 1 control. 1 topical route. 1 intradermal route. When necessary, 2 vehicle groups were added.
Method 1: Induction by topical route.
On day Dl, all animals received 0.2 ml of FCA injected in the foot pad of a hind leg. 6 h before any application, an area of 3 x 5 cm2 on the upper scapular region was shaved. Experimental group: on days Dl, D3 & D5, 0.5 ml of the test substance was applied to the shaved area at the same site (open application). Control group: the animals were exposed to the vehicle without the test agent.
Method 2: Induction by injection.
The injection was made with the test agent incorporated in FCA. Experimental group: on day D5, the animals received a single injection of the mixture[FCA/(vehicle 1+ test substance)] (1:1) into the foot pad of a hind leg, Control group: the animals were given the same injection, but without the lest substance (FCA/vehicle). From day D5 to D16, the animals received no treatment. On day D12 they were prepared for the challenge.
Challenge
The back of all animals, including controls, was shaved and depilated with wax. On day D16, the challenge applications were performed: open topical applications of 10 µL of the test substance on the lumbar region. The test agent was generally used at half the induction concentration. All animals including controls received the same challenge materials. Reactions were evaluated at 24 and 48 h (DI7 and D18). - Challenge controls:
- All animals including controls received the same challenge materials.
- Positive control substance(s):
- yes
- Remarks:
- Formaldehyde, benzocaine, dinitro 2,4 chlorobenzene
Results and discussion
- Positive control results:
- Sensitization rate
Method 1 (Topical route):
DNCB: 100%
Formaldehyde: 20%
Benzocaine: 0%
Method 2 (Injection route):
DNCB: 100%
Formaldehyde: 80%
Benzocaine: 30%
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 24 and 48h
- Group:
- other: test group, method 1 (topical rout)
- Dose level:
- Induction: 0.18 mmol/L, Challange: 0.09 mmol/L
- No. with + reactions:
- 7
- Total no. in group:
- 24
- Clinical observations:
- sensitization rate: 30%
- Remarks on result:
- other: Reading: other: 24 and 48h. Group: other: test group, method 1 (topical rout). Dose level: Induction: 0.18 mmol/L, Challange: 0.09 mmol/L. No with. + reactions: 7.0. Total no. in groups: 24.0. Clinical observations: sensitization rate: 30%.
- Reading:
- other: 24 and 48h
- Group:
- other: test group method 2 (injection route)
- Dose level:
- Induction: 0.18 mmol/L, Challange: 0.09 mmol/L
- No. with + reactions:
- 18
- Total no. in group:
- 24
- Clinical observations:
- sensitization rate: 75%
- Remarks on result:
- other: Reading: other: 24 and 48h. Group: other: test group method 2 (injection route). Dose level: Induction: 0.18 mmol/L, Challange: 0.09 mmol/L. No with. + reactions: 18.0. Total no. in groups: 24.0. Clinical observations: sensitization rate: 75%.
Any other information on results incl. tables
The % of sensitized (sensitization rate) animals is determined: those showing a reaction greater than that of the controls at least once in the two readings, are considered sensitized. The number of animals with + reactions is not given in the publication and was calculated based on the sensitization rate for group level of 24 animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the findings of this study the test substance was considered to be a skin sensitizer.
- Executive summary:
o-phenylenediamine was tested to predict and assess allergic reactions after application. The first method is an open epidermal induction and challenge, the intensity of the reaction being maximized by injecting Freund's complete adjuvant into the foot pad. The second method allows detection of weaker allergens and is a quasi-intradermal induction: both the adjuvant and test substance are injected into the foot pad. In both protocols, the challenge consisted of a single topical application in the lumbar region of 10 µL of test substance. Following these protocols the sensitization rate for the open epidermal induction was 30% and for the intradermal induction 75%. Based on the findings of this study the test substance was considered to be a skin sensitizer.
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.
