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EC number: 202-196-5 | CAS number: 92-84-2
- 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
Skin irritation / corrosion
- OECD 404
- No sign of dermal irritation was found
- Result: not irritating to the skin
Eye irritation
- OECD 405
- All effects found were fully reversible within 72hrs
- Result: not irritating to the eye
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-12-17 to Feb 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- GLP declaration included in full study report.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, UK
- Weight at start of study: 2.36 - 2.48 kg
- Age at start of study: 12 - 16 weeks
- Identification: Ear mark and cage label
- Acclimatisation: min 5 days
- Housing: individually in suspended metal cases
- Diet: Rabbit Diet, Preston Farmers Ltd, New Leake, Boston, Lincolnshire, UK, ad libitum
- Water: drinking water, ad libitum
- Room temperature: 17 - 21°C
- Relative humidity: 45 - 50 %
- Air exchange rate: approx. 15 per hour
- Lighting: 12 hours light / 12 hours darkness - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- - 0.5 g of the test material moistend with 0.5 ml of distilled water.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- One hour, 24, 48 and 72 hours after removal of the patch.
- Number of animals:
- 3
- Details on study design:
- - Area of exposure: 2.5 x 2.5 cm
- Type of patch: gauze patch
- Removal of residual test material four hours after application.
- Removal of residual test material by gentle swabbing with cotton wool soaked in distilled water.
SCORING SYSTEM:
According to Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, TX, "The Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics". - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material, CA 794, was found to be a non-irritant to rabbit skin according to the EEC labelling regulations and requires no symbol or risk phrase.
- Executive summary:
Summary
The potential for skin irritation/corrosion of the test substance was investigated by applying the test substance to the skin of 3 New Zealad White rabbits.
No evidence of skin irritation was noted during the study period.
The test material, CA 794, was found to be a non-irritant to rabbit skin according to the EEC labelling regulations and requires no symbol or risk phrase.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-12-30 to Feb 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- GLP declaration attached to full study report.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Nottingham University, School of Agriculture, Sutton Bonington, Leichestershire, UK and David Percival, Moston, Sandbach, Cheshire, UK
- Weight at start of study: 2.86 - 3.25 kg
- Age at start of study: 12 - 16 weeks
- Acclimatisation: min 5 days
- Identification: Ear mark and cage label
- Housing: Suspended metal cages
- Diet: Rabbit Diet, Preston Farmers Ltd., New Leake, Boston, Lincolnshire, UK, ad libitum
- Water: drinking water, ad libitum
- Room temperature: 17 - 18°C
- Relative humidity: 45 - 50 %
- Air exchange rate: 15 per hour
- Lighting: 12 hours light, 12 hours darkness - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes: Untreated eye was used as control.
- Amount / concentration applied:
- - A volume of 0.1 ml of the test material which was found to weigh 86.6 mg
- Duration of treatment / exposure:
- acc. to guideline.
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Scoring according to Draize J.H., 1959 Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics". - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: Max. score @ 1hr
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: Max. score @ 1hr
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Remarks on result:
- other: Max. score @ 1hr
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Iridial inflammation was confined to two treated eyes one hour after treatment. No iridal effects were noted at subsequent observations.
Conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 hour observation, but was confined to minimal conjunctival redness in one treated eye at the 48-hour observation. All treated eyes were normal at the 72-hour observations. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was found to be non-irritant to the rabbit eye according to EEC labelling regulations and requires no symbol or risk phrase.
- Executive summary:
Summary
The potential for eye irritation/corrosion of the test substance was investigated by applying the test substance to the eyes of 3 New Zealad White rabbits.
No evidence of eye irritation was noted during the study period.
The test material was found to be a non-irritant to the rabbit eye according to the EEC labelling regulations and requires no symbol or risk phrase.
Reference
Individual and mean scores for Cornea, Iris & Conjunctivae
Rabbit number |
Time after treatment [h] |
Cornea opacity |
Iridial effects |
Conjunctival redness |
Conjunctival chemosis |
124 |
1 |
0 |
0 |
2 |
1 |
24 |
0 |
0 |
1 |
0 |
|
48 |
0 |
0 |
1 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
TOTAL 24, 48 & 72 hrs |
0 |
0 |
2 |
0 |
|
Mean * |
0.0 |
0.0 |
0.7 |
0 |
|
137 |
1 |
0 |
1 |
2 |
1 |
24 |
0 |
0 |
1 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
TOTAL 24, 48 & 72 hrs |
0 |
0 |
1 |
0 |
|
Mean * |
0.0 |
0.0 |
0.3 |
0.0 |
|
135 |
1 |
0 |
1 |
2 |
1 |
24 |
0 |
0 |
1 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
TOTAL 24, 48 & 72 hrs |
0 |
0 |
1 |
0 |
|
Mean * |
0.0 |
0.0 |
0.3 |
0.0 |
|
(*) Individual mean of 24, 48 and 72-hour readings |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
Two studies on skin irritation were considered for the present registration dossier (see IUCLID 5). One of these studies was conducted according to GLP and to previous OECD guidelines, while the other study was conducted to a standard protocol (similar to OECD 404) before implementation of GLP and development of OECD guidelines. Although the OECD study is regarded as key study it is missing some information on the purity of the test item.Since starting material for a synthesis of phenothiazine is diphenylamine, diphenylamine can be regarded as the most relevant impurity. Following the summary and conclusion drawn from the European Union Risk Assessment Report on diphenylamine (final version approved on 2008 -05 -29), data on skin irritancy indicates no to very slight effects to rabbit skin. The non-irritant results of the present phenothiazine study could theoretically be due to dilution of the test item phenothiazine with its precursor substance diphenylamine as main impurity. However, this is regarded as unlikely, due to the nature of the test material e.g. as a precursor of medicinal substances, where usually high purities are demanded. Potential dilution should therefore not be an issue. In conclusion the results of the present study are regarded as reliable, not indicating irritant effects to skin due to exposure to the test item phenothiazine. In addition, no irritant effects to the skin were found in the pre-OECD study, where the purity of phenothiazine used for testing (99.80 %) is given.
Eye irritation
Two studies on eye irritation were considered for the present registration dossier (see IUCLID 5). One of these studies was conducted according to GLP and to previous OECD guidelines, while the other study was conducted to a standard protocol (similar to OECD 405) before implementation of GLP and development of OECD guidelines. Although the OECD study is regarded as key study it is missing some information on the purity of the test item.Since starting material for a synthesis of phenothiazine is diphenylamine, diphenylamine can be regarded as the most relevant impurity. Following the summary and conclusion drawn from the European Union Risk Assessment Report on diphenylamine (final version approved on 2008 -05 -29), data on eye irritation is conflicting, but indicates severe eye damage due to diphenylamine treatment. However, the present OECD study using phenothiazine as test item clearly resulted in a non-irritant result (i.e. some effects were found, all of them reversible within 72hrs and not leading to classification either according to 67/548/EEC or 1278/2008/EC). Therefore, even if diphenylamine was theoretically present as an impurity it did not exhibit any irritating effect. In addition, no irritant effects to the eye were found in the pre-OECD study, where the purity of phenothiazine used for testing (99.80 %) is given.Justification for classification or non-classification
Based on the studies on skin irritation and the studies on eye irritation no classification is necessary either according to 67/548/EEC or 1272/2008/EC.
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.
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