Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 601-593-4 | CAS number: 119302-19-1
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 October 1997 - 27 November 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: the study was conducted according to OCED Guideline 406 and EU method B.6 without deviations and based on GLP practices.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 6 weeks old
- Weight at study initiation: < 500 grams
- Housing: Group housing of 5 animals per cage with wire-mesh floors
- Diet (e.g. ad libitum): Standard Guinea Pig Diet, including ascorbic acid (1600 mg/kg); LC-23-B, pellet diameter 4mm (Hope Farms, Woerden, The Neitherlands), ad libitum. Additionally, hay was provided once per week.
- Water (e.g. ad libitum): Tap-water, ad libitum
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 deg C
- Humidity (%): 50%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: Not documented in study report To: Not documented in study report - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- Based on the results of the preliminary irritation study, the test concentrations selected for the Main Study were a 0.5% concentration for the intradermal induction and a 20% concentration for the epidermal induction exposure. A 5% test substance concentration was selected for the challenge phase.
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- Based on the results of the preliminary irritation study, the test concentrations selected for the Main Study were a 0.5% concentration for the intradermal induction and a 20% concentration for the epidermal induction exposure. A 5% test substance concentration was selected for the challenge phase.
- No. of animals per dose:
- 10 females in experimental group
5 females in control group - Details on study design:
- RANGE FINDING TESTS: Prior to the start of the Main Study, the intradermal and epidermal irritancy of Epyrrol was investigated to select test substance concentrations suitable for the induction and challenge phase of the Main Study. The selection was based on the absence of toxicity and on the following criteria for each route and or study phase: INDUCTION (intradermal and epidermal): the highest possible concentration that produces moderate irritation (the intradermal reaction may include slight necrosis (<3 mm in diameter)). CHALLENGE: the maximum non-irritant concentration. Selection of this concentration depends on the number of factors and exact criteria did not always apply. The test system, procedures and techniques were identical to those used during the main study, unless otherwise specified. The animals were selected from stock and were between 5-9 weeks old, and as a consequence the body weights could exceed 500 grams, Body weights were determined prior to treatment.
INTRADERMAL INJECTIONS: A series of four test substance concentrations was used, the highest concentration being the maximum concentration that could technically be injected. Each of two animals received two different concentrations in duplicate (0.1 ml/site) in the clipped scapular region. The injection sites were assessed for irritation 24 and 48 hours after treatment.
EPIDERMAL APPLICATIONS: A series of four test substance concentrations was used; the highest on concentration being the maximum concentration that could technically be applied. Two different concentrations were applied (0.5 ml each) per animal to the clipped flank, using Metalline patches (2X3 cm) mounted on Medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage. The animals received intradermal injections were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
RESULTS:
Based on the results of the preliminary irritation study, the test concentrations selected for the Main Study were a 0.5% concentration for the intradermal induction and a 20% concentration for the epidermal induction exposure. A 5% test substance concentration was selected for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two, Day 1 and Day 8
- Exposure period: 48 hours
- Test groups: Experimental animal groups
- Control group: The control animals were treated as described in the experimental animals, except exposed to vehicle only.
- Site: Flank
- Frequency of applications: Three intradermal injections (0.1 ml/site)
- Duration: 48 hours
- Concentrations: 0.5% on Day 1 and 20% on Day 8
B. CHALLENGE EXPOSURE
- No. of exposures: Single exposure
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Test groups: All animals
- Control group: No data
- Site: Flank (One flank was clipped and treated by epidermal application, using Metalline patches (2X3cm) mounted on medical tape, which were held in place with Micropore tape and subsequently Coban elastic bandage.
- Concentrations: 5% test substance and the vehicle (0.5 ml each)
- Evaluation (hr after challenge): 24 hours after exposure, the skin was cleaned of residual test substance and vehicle. The treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing.
OTHER: OBSERVATIONS:
Mortality/Viability: Twice daily
Toxicity: At least once daily
Body weights: Prior to start and at termination of the study
Irritation: skin reactions were graded according to a numerical scoring system. Furthermore, a description of all other (local) effects were recorded. Whenever necessary, the treated skin-areas were clipped at least 3 hours before the next skin reading to facilitate scoring. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Signs of necrosis and/or scaliness were seen in the treated skin sites of the majority of experimental animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Signs of necrosis and/or scaliness were seen in the treated skin sites of the majority of experimental animals. .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Signs of necrosis and/or scaliness were seen in the treated skin sites of the majority of experimental animals.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Signs of necrosis and/or scaliness were seen in the treated skin sites of the majority of experimental animals. .
- Interpretation of results:
- other: may cause sensitization by skin contact
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Taking into account the intensity and persistence of the responses and comparing these with the skin reactions seen in the control animals, it was considered that hypersensitivity to Epyrrol had been induced in the experimental animals. These results indicate a sensitization rate of 100%. Therefore Epyroll is classified as a skin sensitiser according DSD (R ) and CLP (H317)
Reference
Toxicity/Mortality:
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Body Weights:
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- Migrated from Short description of key information:
GLP study according to OCED Guideline 406 and EU Method B.6 using guinea pigs, the test concentrations selected for the Main Study were a 0.5% concentration for the intradermal induction and a 20% concentration for the epidermal induction exposure. A 5% test substance concentration was selected for the challenge phase.
Justification for selection of skin sensitisation endpoint:
Taking into account the intensity and persistence of the responses and comparing these with the skin reactions seen in the control animals, it was considered that hypersensitivity to Epyrrol had been induced in the experimental animals. These results indicate a sensitization rate of 100%.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
Hypersensitivity to Epyrrol had been induced in the experimental animals, using OCED Guideline 406 and EU Method B.6
Justification for classification or non-classification
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.