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EC number: 230-303-5 | CAS number: 7023-61-2
- 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
Pigment Red 48:2(Ca) is not irritating to skin and 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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The exposure duration was 24 hours. No 48-hour observation point included.
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1955).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24h occlusive application and short post-observation period. No recording of body weight development and clinical signs.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Appearance: red powder
- Batch No.: EG 9146 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Healthy New Zealand White rabbits (Porton strain) aged 10 - 13 weeks with average body weights of 2.84 Kgs {males) and 2.58 Kgs (females), bred on the premises and maintained under a semi-barrier system. Six rabbits (3 males and 3 females) were acclimatized in the test area for one week prior to the start of the trial.
The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (± 1°) and a relative humidity of 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times. - Type of coverage:
- occlusive
- Preparation of test site:
- other: both shaved and abraded
- Vehicle:
- other: 50% polyethylene glycol in water
- Controls:
- not required
- Amount / concentration applied:
- 10 g of the test compound was mixed with 20 mL of deionized water to form a suspension, of which 1.5 mL was applied to the test sites on 2.5 cm square gauze pads (dose of 0.5 g per application site).
- Duration of treatment / exposure:
- 24h
- Observation period:
- After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours.
- Number of animals:
- 3 males and 3 females
- Details on study design:
- Twenty-four hours prior to dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two sites lateral to the midline of the back were used on each rabbit. Immediately before the application of the compound, the right hand side was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand side remained intact.
10g of the compound mixed with 10ml of a 50% aqueous solution of polyethylene glycol to make a suspension of 20ml, 1.0ml of which was applied to each test site on a 2.5cm square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape
After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 hours and f or any further period considered necessary up to 14 days. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: values for intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: values for intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: values for abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: values for abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not determinable
- Interpretation of results:
- GHS criteria not met
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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No assessment of non-ocular local and systemic adverse effects, no rationale for in vivo testing
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):PD 1201
- Batch EG 9146
- Substance type: red pigment
- Physical state: solid
- Purity test date: not available
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Composition: 95% C.I. Pigment Red 48 - Calcium Salt and 5% modified wood rosin derivative - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 10 - 13 weeks
- Housing: single caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum) :ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours daily from 08:00 - 18:00 hours - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 g per eye
- Duration of treatment / exposure:
- single application. For half of the treated eyes, the eyes were rinsed with 200 mL of water 30 seconds after application.
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- The rabbits were examined at 1,6, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A. Corneal damage was assessed after staining with flourescein.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h and 24h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: Grade 1 redness of the conjunctivae observed in all animals at the 1h reading.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Grade 2 chemosis observed in animals with unrinsed eyes at the 1h reading.
- Other effects:
- Rinsing of the eyes had a minor beneficiary effect.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Pigment Red 48:2(Ca) is not irritating to skin as determined in four studies with rabbits performed between 1972 and 1978. The study performed in 1977 by W. Bradley was chosen as key study for skin irritation because the composition and origin of the sample is documented in the report and the study procedure and results are described in sufficient details. The procedure is more stringent than theone described in the OECD testing guideline 404 (1981) as it involves 24h occlusive application onto intact and abraded skin. Under these conditions, no erythema and mild transient edema was observed.
Pigment Red 48:2(Ca) is not irritating to eyes as determined in four studies with rabbits performed between 1972 and 1978. The study performed in 1977 by W. Bradley was chosen as key study for eye irritation because the composition and origin of the sample is documented in the report and the study procedure and results are described in sufficient details. The studies were performed prior to the introduction of GLP, but their design is comparable to OECD testing guideline 405. As for skin irritation, the overall study results range between “slightly irritating” to “non irritating” due to the influence of the additives.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.
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