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EC number: 224-481-3 | CAS number: 4378-61-4
- 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:
In a FDA guideline primary skin irritation test in rabbits with the test item (Pigment Red 168) neither erythema nor edema were observed at any reading time in any animal. In a second, analogue study, also no skin reactions were observed. Therefore, Pigment Red 168 can be regarded as not skin irritating.
Eye irritation:
In a FDA guideline primary eye irritation test in rabbits with Pigment Red 168 no ocular reactions were observed at any time in any animal. In a second, analogue study, the test item (pigment Red 168) caused slight conjunctivae redness and chemosis. All signs of irritation were fully reversible within 72 h. Therefore, the test item (Pigment Red 168) can be regarded as not eye irritating.
Respiratory tract:
Based on available data the substance is considered likely to behave like an inert dust. Consequently the substance is considered not to exert any local irritative effects. Therefore, it is concluded, that testing is not necessary to reach the scientific conclusion that classification is not warrantable.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.41
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: J. Scheele, Büderich, Germany
- Housing: single caged
- Diet: standard diet Ssniff K 4
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact or shaved abraded with a scarifying instrument
- Vehicle:
- other: type vehicle used not specified
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g of the test item (The amount used is not explicitely specified in the report, but according to the guideline followed 0.5 gram is requested in the case of solids and semisolids) mixed with an appropriate solvent
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- 0.5 g of the test substance diluted in an appropriate solvent is spread on a gauze patch, measuring 2,5 x 2,5 cm which is applied on the abraded and intact skin of 6 albino rabbits, clipped free of hair under occlusive conditions. After 24 hours of exposure, the patches are removed and reactions are recorded. Readings are made again 72 hours after application.
(Abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding) - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No skin reactions were observed in any animal at any timepoint.
- Other effects:
- no other effects reported
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- The test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008
- Executive summary:
Test material was subject to an acute dermal irritation/corrosion test in 6 New Zealand White rabbits according to CFR guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g of the test substance dissolved in an appropriate solvent for 24 h under occlusive conditions and the skin responses were recorded 24 h and 72 after application (i.e. 0 and 48h after patch removal). No skin reactions were observed. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Test performed before OECD and GLP guidelines. Important aspects (dosing, observation times, grading criteria) comparable with current OECD guidelines
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- GLP compliance:
- no
- Remarks:
- pre-guideline study
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: J. Scheele, Büderich, Germany
- Housing: single caged
- Diet: standard diet Ssniff K 4
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one eye, remaining untreated, serves as a control
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- 24 h (rinsing not explicitelx specified in the report)
- Observation period (in vivo):
- examinations at 24, 48, 72 h , and 7 days after instillation
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 100 mg of the test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control.The eyes are examined and the grade of ocular reaction is recorded at 24, 48, and 72 hours and 7 days. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein. Any or all eyes may be washed with sodium chloride solution after the 24-hour reading.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 1-6 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 1-6 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 1-6 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (chemosis) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1-6 each
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no signs of irritation (conjunctivae) at any time
- Irritant / corrosive response data:
- No ocular reactions were observed in any animal at any time.
- Other effects:
- no other effects reported
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Regulation (EC) 1272/2008
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
- Executive summary:
The test material was subject to an acute eye irritation/corrosion test in 6 New Zealand White rabbits according to CFR guideline. 100 mg test substance were placed into the conjunctival sac of one eye of each rabbit. Reactions were recorded frequently during the observation period of 7 days. No effects were observed for all irritation parameter during the study. Therefore, the test item has not to be classified for eye irritation according to Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
From two equivalent studies with coincident results the posterior was selected as key study.
Justification for selection of eye irritation endpoint:
From two equivalent studies with similar results the posterior was selected as key study.
Justification for classification or non-classification
Pigment Red 168 has been tested in vivo for skin irritative properties in two tests in rabbits. In these FDA guideline compliant studies, the substance did not cause any skin reactions at any time in any animal. Therefore, Pigment Red 168 does not have to be classified as skin irritating according to Directive 67/548/EEC and Regulation (EU) No 1272/2008.
Pigment Red 168 has been tested in vivo for eye irritative properties in two tests in rabbits according to FDA guideline. In the key study no signs of irritation were observed at any time. In the supporting study the substance caused only very slight, transient irritation to the eyes which might be attributed to mechnical attrition. The individual and group mean of scores read 1, 2 and 3 days after treatment were well below the classification criteria laid down in the Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, Pigment Red 168 does not have to be classified as eye irritating.
It can reasonably be deduced that Pigment Red 168 does not cause respiratory tract irritation and thus does not have to be classified according to the criteria laid down in Directive 67/548/EEC and in Regulation (EC) No 1272/2008, because Pigment Red 168 did cause only very slight, fully reversible irritative effects in the eyes and no skin reactions and does not have to be classified as either skin or eye irritating. Moreover, Pigment Red 168, in the unlikely event of being inhaled as a dust, is considered not to cause more severe effects than an inert dust, because its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.
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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