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EC number: 261-785-5 | CAS number: 59487-23-9
- 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
The primary skin irritation potential of a close structural analogue (PO38) was investigated according to OECD test guideline no 404. The test item (0.5 g) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. A red discoloration was noted on the treated are. No skin reactions, neither erythema nor edema, were observed at any time point (score 0). No signs of systemic toxicity were observed.
In a OECD guideline and GLP compliant primary skin irritation test in rabbits, a close structural analogue (Pigment Red 112) caused grade 0-1 erythema and edema after 30-60 minutes, while neither erythema nor edema were observed 24, 48 and 72 hours after application of the test substance. Therefore, the test item (Pigment Red 112) was regarded as not skin irritating.
The irritation potential of a close structural analogue (PO 022) was assessed by means of the Human Skin Model Test according to OECD TG 439. After treatment with the test item the relative absorbance values did not decrease relevantly (98.9%; threshold for irritancy:=50%). Therefore, the test item is not considered to possess an irritant potential.
The primary eye irritation potential of a close structural analogue (PO 038) was investigated according to OECD guideline no 405. The test item (0.1 g) was applied to the intact eye of three New Zealand White rabbits for 1 h. Reddening of the conjunctivae was noted in all three animals 1 h after the treatment and persisted up to 48 h in two animals. Slight swelling was noted in one and slight ocular discharge was noted in two animals in the 1 h reading.
The individual mean scores calculated across the three scoring times (24, 48, 72 h) were for corneal opacity 0.0 (three animals), for iris 0.0 (three animals), for conjunctivae reddening 0.0, 0.7 and 0.7 and for chemosis 0.0 (three animals).
No abnormal findings were observed in the treated eye of any animal 72 h after treatment.
There was no indication of systemic toxicity.
In a OECD guideline and GLP compliant primary eye irritation test in rabbits, a close structural analogue (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Test item (Pigment Red 112) was regarded as not eye irritating.
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:
- From 24 APR 2007 to 05 MAY 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404; EU method B4), in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste, Linxe, France)
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.27 kg, 2,7 kg, 2,64 kg, all within the normal range of variability
- Housing: individual boxes
- Diet: standard laboratory diet, ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 (air condition)
- Humidity (%): 32-64
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): a not further quantified amount of destilled water was used to moisten the test item - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 (female)
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: as in OECD TG 404 described, reading at 1, 24, 48 and 72 h after removal of test item. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h after removal of patches
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h after removal of patches
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritant / corrosive response data:
- - No erythema or oedema were observed at any time point.
- Other effects:
- - Changes in body weight during the course of the study were not remarkable.
- No signs of systemic toxicity were observed.
- A red coloration was noted on the treated areas. Despite this coloration the macroscopical examinations of the cutaneous reaction were possible. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to skin when tested under the conditions of the OECD guideline 404.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no 404.
The test item (0.5 g) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. A red discoloration was noted on the treated are. No skin reactions, neither erythema nor edema, were observed at any time point (score 0). No signs of systemic toxicity were observed.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 July - 15 July 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed in accordance with OECD and GLP guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 3.0 kg to 3.9 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethyleneglycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 ml PEG 400 to moisten the test item
- Lot/batch no. (if required): not stated - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was cautiously removed
- Time after start of exposure: 4 hours
SCORING SYSTEM:
as described by Draize [identical to EU Method B.4] assessed approximately 30 - 60 min, 24, 48, and 72 h after the romoval of the test item - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema grade 0 - 0 -1 observed in the three animals at 30-60 min reading were fully reversible within 24 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema grade 0 - 0 - 1 observed in the three animals at 30-60 min reading were fully reversible within 24 hours
- Irritant / corrosive response data:
- Scores (oedema or erythema) were 0 at 24, 48 and 72 h after removal of dressing in all animals.
- Other effects:
- Weak pink staining produced by the test item was present at the 30-60-minute and the 24-hour readings.
- Conclusions:
- 67/548/EEC: Skin irritation: no classification warranted
1272/2008/EC: Skin irritation: no classification warranted
In a OECD guideline and GLP compliant primary skin irritation test in rabbits, the test item (Pigment Red 112) caused grade 0-1 erythema and edema after 30-60 minutes, while neither erythema nor edema were observed 24, 48 and 72 hours after application of the test substance. Therefore, the test item (Pigment Red 112) was regarded as not skin irritating. - Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 24 hours after treatment for all animals. Staining of the treated skin was noted in all animals until the 24 -hour reading. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant irritative or irreversible damage to the skin. Therefore, Permanent-Rot FGR 02 is considered to be "not irritating" to rabbit skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 MAR 2012 to 02 APR 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 439) and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (Original Guideline adopted July 22, 2010)
- Deviations:
- no
- GLP compliance:
- yes
- Amount / concentration applied:
- Approximately 11 mg of the neat test item were applied to three EPISKIN (Skinethic) tissues. Additionally, the tissues were wetted with 20 µL of deionised water.
- Duration of treatment / exposure:
- The skin equivalents were exposed to the test item for 15 minutes. After completion of the treatment the test item was rinsed off and the skin equivalents were incubated for further 42 hours.
- Details on study design:
- Approximately 11 mg of the neat test item and 10 µL of the negative control (deionised water) or the positive control (5% sodium lauryl sulfate) were applied to each three EPISKin (Skinethic) tssues. Additionally, the test item treated tissues were wetted with 20 µL of deionised water. The test item as well as the controls were rinsed off after 15 minutes treatment. After further 42 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 70 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at a wavelength of 570 nm.
- Irritation / corrosion parameter:
- other: Relative Absorbance [%]
- Value:
- 107.2
- Irritation / corrosion parameter:
- other: Relative Absorbance [%]
- Value:
- 93.1
- Irritation / corrosion parameter:
- other: Relative Absorbance [%]
- Value:
- 96.4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of tets substance by means of the Human Skin Model Test according to OECD TG 439.
Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes.
Approximately 11 mg of the neat test item were applied to each tissue, spread to match the tissue size. Additionally, the test item tissues were wetted with 20 µL of deionised water.
The test item and the positive and negative controls were washed off the skin tissues after 15 minutes treatment. After further incubation for about 42.5 hours the tissues were treated with the MTT solution for 3 hours following 69.5 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
10 µL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD in the range from 0.6 to 1.5 for the15 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 29.4% thus ensuring the validity of the test system.
The standard deviations between the % variabilities of the test item, the positive and negative controls were below 8% (threshold of the "OECD TG 439 Guideline for the Testing of Chemicals 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: 18%) thus ensuring the validity of the study.
After treatment with the test item the relative absorbance values did not decrease relevantly (98.9%; threshold for irritancy:=50%). Therefore, the test item is not considered to possess an irritant potential.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 28 MAR 2012 to 02 APR 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 439) and in compliance with GLP.
- Justification for type of information:
- See rationale and justification for the analogue read-across approach for the registration of the nanoform of Pigment Red 187(chapter 13).
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- (Original Guideline adopted July 22, 2010)
- Deviations:
- no
- GLP compliance:
- yes
- Amount / concentration applied:
- Approximately 11 mg of the neat test item were applied to three EPISKIN (Skinethic) tissues. Additionally, the tissues were wetted with 20 µL of deionised water.
- Duration of treatment / exposure:
- The skin equivalents were exposed to the test item for 15 minutes. After completion of the treatment the test item was rinsed off and the skin equivalents were incubated for further 42 hours.
- Details on study design:
- Approximately 11 mg of the neat test item and 10 µL of the negative control (deionised water) or the positive control (5% sodium lauryl sulfate) were applied to each three EPISKin (Skinethic) tssues. Additionally, the test item treated tissues were wetted with 20 µL of deionised water. The test item as well as the controls were rinsed off after 15 minutes treatment. After further 42 hours incubation the tissues were treated with the MTT solution for 3 hours following approximately 70 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at a wavelength of 570 nm.
- Irritation / corrosion parameter:
- other: Relative Absorbance [%]
- Value:
- 107.2
- Irritation / corrosion parameter:
- other: Relative Absorbance [%]
- Value:
- 93.1
- Irritation / corrosion parameter:
- other: Relative Absorbance [%]
- Value:
- 96.4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.
- Executive summary:
This in vitro study was performed to assess the irritation potential of tets substance by means of the Human Skin Model Test according to OECD TG 439.
Three tissues of the human skin model EpiSkin™ were treated with the test item, the negative or the positive control for 15 minutes.
Approximately 11 mg of the neat test item were applied to each tissue, spread to match the tissue size. Additionally, the test item tissues were wetted with 20 µL of deionised water.
The test item and the positive and negative controls were washed off the skin tissues after 15 minutes treatment. After further incubation for about 42.5 hours the tissues were treated with the MTT solution for 3 hours following 69.5 hours extraction of the colorant from the cells. The amount of extracted colorant was determined photometrically at 570 nm.
10 µL of either the negative control (deionised water) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.
After treatment with the negative control the absorbance values were well within the required acceptability criterion of mean OD in the range from 0.6 to 1.5 for the15 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 29.4% thus ensuring the validity of the test system.
The standard deviations between the % variabilities of the test item, the positive and negative controls were below 8% (threshold of the "OECD TG 439 Guideline for the Testing of Chemicals 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”: 18%) thus ensuring the validity of the study.
After treatment with the test item the relative absorbance values did not decrease relevantly (98.9%; threshold for irritancy:=50%). Therefore, the test item is not considered to possess an irritant potential.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 12 July - 15 July 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed in accordance with OECD and GLP guidelines.
- Justification for type of information:
- See rationale and justification for the analogue read-across approach for the registration of the nanoform of Pigment Red 187(chapter 13).
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 3.0 kg to 3.9 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethyleneglycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 ml PEG 400 to moisten the test item
- Lot/batch no. (if required): not stated - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 cm x 2.5 cm
- Type of wrap if used: surgical gauze patch (Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was cautiously removed
- Time after start of exposure: 4 hours
SCORING SYSTEM:
as described by Draize [identical to EU Method B.4] assessed approximately 30 - 60 min, 24, 48, and 72 h after the romoval of the test item - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema grade 0 - 0 -1 observed in the three animals at 30-60 min reading were fully reversible within 24 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: erythema grade 0 - 0 - 1 observed in the three animals at 30-60 min reading were fully reversible within 24 hours
- Irritant / corrosive response data:
- Scores (oedema or erythema) were 0 at 24, 48 and 72 h after removal of dressing in all animals.
- Other effects:
- Weak pink staining produced by the test item was present at the 30-60-minute and the 24-hour readings.
- Conclusions:
- 67/548/EEC: Skin irritation: no classification warranted
1272/2008/EC: Skin irritation: no classification warranted
In a OECD guideline and GLP compliant primary skin irritation test in rabbits, the test item (Pigment Red 112) caused grade 0-1 erythema and edema after 30-60 minutes, while neither erythema nor edema were observed 24, 48 and 72 hours after application of the test substance. Therefore, the test item (Pigment Red 112) was regarded as not skin irritating. - Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 30 - 60 min, 24, 48 and 72 hours after removal of the dressing. The application of the test item to the skin resulted in mild, early-onset and transient signs of irritation such as erythema. These effects were reversible and were no longer evident 24 hours after treatment for all animals. Staining of the treated skin was noted in all animals until the 24 -hour reading. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant irritative or irreversible damage to the skin. Therefore, Permanent-Rot FGR 02 is considered to be "not irritating" to rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 24 APR 2007 to 05 MAY 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 404; EU method B4), in compliance with GLP
- Justification for type of information:
- See rationale and justification for the analogue read-across approach for the registration of the nanoform of Pigment Red 187(chapter 13).
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste, Linxe, France)
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.27 kg, 2,7 kg, 2,64 kg, all within the normal range of variability
- Housing: individual boxes
- Diet: standard laboratory diet, ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 (air condition)
- Humidity (%): 32-64
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): a not further quantified amount of destilled water was used to moisten the test item - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 (female)
- Details on study design:
- TEST SITE
- Area of exposure: approximately 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: as in OECD TG 404 described, reading at 1, 24, 48 and 72 h after removal of test item. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h after removal of patches
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h after removal of patches
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritant / corrosive response data:
- - No erythema or oedema were observed at any time point.
- Other effects:
- - Changes in body weight during the course of the study were not remarkable.
- No signs of systemic toxicity were observed.
- A red coloration was noted on the treated areas. Despite this coloration the macroscopical examinations of the cutaneous reaction were possible. - Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to skin when tested under the conditions of the OECD guideline 404.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no 404.
The test item (0.5 g) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the test item. A red discoloration was noted on the treated are. No skin reactions, neither erythema nor edema, were observed at any time point (score 0). No signs of systemic toxicity were observed.
Referenceopen allclose all
Results after treatment with test substance and controls
Dose group |
Treatment Interval |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Tissues |
Relative Absorbance [%] Tissue 1, 2 + 3** |
Standard Deviation [%] |
Rel. Absorbance [% of Negative Control]*** |
Negative Control |
15 min |
1.107 |
1.040 |
1.124 |
1.090 |
101.5 95.4 103.1 |
4.0 |
100.0 |
Positive Control |
15 min |
0.321 |
0.304 |
0.336 |
0.320 |
29.4 27.9 30.8 |
1.4 |
29.4 |
Test Item |
15 min |
1.169 |
1.015 |
1.051 |
1.078 |
107.2 93.1 96.4 |
7.4 |
98.9 |
* Mean of two replicate wells after blank correction
** relative
absorbance per tissue [rounded values]: (100 x (absorbance tissue))
/ (mean absorbance negative control)
*** relative
absorbance per treatment group [rounded values]: (100 x (mean
absorbance test item)) / (mean absorbance negative
control)
After treatment with the test item the relative absorbance values did not decrease relevantly (98.9%; threshold for irritancy: =50%). Therefore, the test item is not considered to possess an irritant potential.
Results after treatment with test substance and controls
Dose group |
Treatment Interval |
Absorbance 570 nm |
Absorbance 570 nm |
Absorbance 570 nm |
Mean Absorbance of 3 Tissues |
Relative Absorbance [%] Tissue 1, 2 + 3** |
Standard Deviation [%] |
Rel. Absorbance [% of Negative Control]*** |
Negative Control |
15 min |
1.107 |
1.040 |
1.124 |
1.090 |
101.5 95.4 103.1 |
4.0 |
100.0 |
Positive Control |
15 min |
0.321 |
0.304 |
0.336 |
0.320 |
29.4 27.9 30.8 |
1.4 |
29.4 |
Test Item |
15 min |
1.169 |
1.015 |
1.051 |
1.078 |
107.2 93.1 96.4 |
7.4 |
98.9 |
* Mean of two replicate wells after blank correction
** relative
absorbance per tissue [rounded values]: (100 x (absorbance tissue))
/ (mean absorbance negative control)
*** relative
absorbance per treatment group [rounded values]: (100 x (mean
absorbance test item)) / (mean absorbance negative
control)
After treatment with the test item the relative absorbance values did not decrease relevantly (98.9%; threshold for irritancy: =50%). Therefore, the test item is not considered to possess an irritant potential.
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:
- From 30 APR 2007 to 10 MAY 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 405; EU method B5), in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste, Linxe, France)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: between 2.63 and 3.04 kg, all within the normal range of variability
- Housing: individual boxes
- Diet: standard laboratory diet. ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 (air condition)
- Humidity (%): 42-68
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with isotonic solution
- Time after start of exposure: 1 h
SCORING SYSTEM: according to OECD TG 405, reading at 1, 24, 48 and 72 h after removal of test item
TOOL USED TO ASSESS SCORE: occular examination - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24,48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effect
- Irritant / corrosive response data:
- Slight reddening of the conjunctivae was noted in the three animals 1 h after treatment and persisted up to 48 h in two animals.
1 h reading: slight swelling (chemosis) in 1 animal, slight occular discharges in all treated animals
24 h and 48 h reading: slight conjunctivae redness in 2 animals.
72 h reading: no abnormal findings observed in any animal.
No coloration of the treated eyes was noted at any of the reading times. - Other effects:
- - changes in body weight during the course of the study were not remarkable.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to skin when tested under the conditions of the OECD guideline 405.
- Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD guideline no 405. The test item (0.1 g) was applied to the intact eye of three New Zealand White rabbits for 1 h. Redding of the conjunctivae was noted in all three animals 1 h after the tratment and persisited up to 48 h in two animals. Slight swelling was noted in one and slight occular discharge was noted in two animals in the 1 h reading.
The individual mean scores calculated across the three scoring times (24, 48, 72 h) were for corneal opacity 0.0 (three animals), for iris 0.0 (three animals), for conjunctivae redding 0.0, 0.7 and 0.7 and for chemosis 0.0 (three animals).
No abnormal findings were observed in the treated eye of any animal 72 h after treatment.
There was no indication of systemic toxicity.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 30 APR 2007 to 10 MAY 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 405; EU method B5), in compliance with GLP
- Justification for type of information:
- See Rationale and Justification for the Analogue Read-Across Approach for the registration of the Nanoform of Pigment Red 187 using Pigment Red 22, Pigment Red 112 and Pigment Orange 38 as Source Substances (Chapter 13)
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste, Linxe, France)
- Age at study initiation: 12-13 weeks
- Weight at study initiation: between 2.63 and 3.04 kg, all within the normal range of variability
- Housing: individual boxes
- Diet: standard laboratory diet. ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 (air condition)
- Humidity (%): 42-68
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 1 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with isotonic solution
- Time after start of exposure: 1 h
SCORING SYSTEM: according to OECD TG 405, reading at 1, 24, 48 and 72 h after removal of test item
TOOL USED TO ASSESS SCORE: occular examination - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24,48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not relevant since no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effect
- Irritant / corrosive response data:
- Slight reddening of the conjunctivae was noted in the three animals 1 h after treatment and persisted up to 48 h in two animals.
1 h reading: slight swelling (chemosis) in 1 animal, slight occular discharges in all treated animals
24 h and 48 h reading: slight conjunctivae redness in 2 animals.
72 h reading: no abnormal findings observed in any animal.
No coloration of the treated eyes was noted at any of the reading times. - Other effects:
- - changes in body weight during the course of the study were not remarkable.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to skin when tested under the conditions of the OECD guideline 405.
- Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD guideline no 405. The test item (0.1 g) was applied to the intact eye of three New Zealand White rabbits for 1 h. Redding of the conjunctivae was noted in all three animals 1 h after the tratment and persisited up to 48 h in two animals. Slight swelling was noted in one and slight occular discharge was noted in two animals in the 1 h reading.
The individual mean scores calculated across the three scoring times (24, 48, 72 h) were for corneal opacity 0.0 (three animals), for iris 0.0 (three animals), for conjunctivae redding 0.0, 0.7 and 0.7 and for chemosis 0.0 (three animals).
No abnormal findings were observed in the treated eye of any animal 72 h after treatment.
There was no indication of systemic toxicity.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 21 July - 15 July 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed in accordance with OECD and GLP guidelines.
- Justification for type of information:
- See Rationale and Justification for the Analogue Read-Across Approach for the registration of the Nanoform of Pigment Red 187 using Pigment Red 22, Pigment Red 112 and Pigment Orange 38 as Source Substances (Chapter 13)
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 2.9 kg to 3.2 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- other: polyethyleneglycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- One administration 24 hours
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively
REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since on effects occured
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: grade 1 chemosis was observed in all animals at 1 hour and was fully reversible within 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The score refers to redness of conjunctiva, which was evident in all animals 1 h after treatment (score 1 in all 3 animals). The value of 0.11 is the mean (of the three assessments at 24, 48 and 72 h) for all animals combined as well as for each individual animal. At 48 and 72 h, this score was 0 in all animals. Other parameters examined (opacity of cornea, iris, chemosis of conjunctiva) showed scores of 0 at the relevant time points.
- Other effects:
- Red staining of eye discharge was observed at 1 hour after application.
- Conclusions:
- 67/548/EEC: Eye irritation: no classification warranted
1272/2008/EC: Eye irritation: no classification warranted
In a OECD guideline and GLP compliant primary eye irritation test in rabbits, Test item (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Test item (Pigment Red 112) was regarded as not eye irritating. - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 July - 15 July 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed in accordance with OECD and GLP guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Animal specifics: Hoechst AG, conventional breed
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 2 months to 5 months
- Weight at study initiation: 2.9 kg to 3.2 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet (e.g. ad libitum): standard laboratory diet (Altromin 2013) ad libitum
- Water (e.g. ad libitum): deionized chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° ± 2°C (air-condition)
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- other: polyethyleneglycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- One administration 24 hours
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal, the right eyes served as control respectively
REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24, 48 and 72 h after administration) took place
- Time after start of exposure: see above
TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since on effects occured
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not relevant since no effects occured
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: grade 1 chemosis was observed in all animals at 1 hour and was fully reversible within 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- other: after 24, 48 and 72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The score refers to redness of conjunctiva, which was evident in all animals 1 h after treatment (score 1 in all 3 animals). The value of 0.11 is the mean (of the three assessments at 24, 48 and 72 h) for all animals combined as well as for each individual animal. At 48 and 72 h, this score was 0 in all animals. Other parameters examined (opacity of cornea, iris, chemosis of conjunctiva) showed scores of 0 at the relevant time points.
- Other effects:
- Red staining of eye discharge was observed at 1 hour after application.
- Conclusions:
- 67/548/EEC: Eye irritation: no classification warranted
1272/2008/EC: Eye irritation: no classification warranted
In a OECD guideline and GLP compliant primary eye irritation test in rabbits, Test item (Pigment Red 112) caused grade 1 (1/3 animals) chemosis after one hour and conjunctival reddening grade 1 (3/3 animals) after 1 hours and grade 1 (1/3 animals) after 24 hours. No effects were observed for these and other parameters at the other reading times up to 72 hours. Therefore, Test item (Pigment Red 112) was regarded as not eye irritating.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification, as no adverse effects were observed.
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.