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EC number: 229-107-2 | CAS number: 6410-41-9
- 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
Skin Effects
PR005
0.5 g of the test item moistened with tap water was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for twenty 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. Therefore, it is concluded that the test item is not irritating to skin.
Eye Effects
PR112
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.
PO38
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.
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 06 JUN 2011 to 21 JUN 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- other: Biological Evaluation of Medical Devices, Part10: Tests for irritation and Sensitization
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DNA Rabbitry, Elk River, MN, USA
- Age at study initiation: young adults
- Weight at study initiation: 2.6 kg (male), 2.3 kg (female), 2.2 kg (male)
- 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
- According to AAALAC International recommendations for rabbits - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: control: wetted patch; positive control: 2.5% and 5% sodium lauryl sulfate
- 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 tap water was used to moisten the test item - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 3 (2 males, 1 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): diluted alcohol
- Time after start of exposure: 24 h
SCORING SYSTEM: in accordance with OECD TG 404, reading at 1, 24, 48 and 72 h after removal of test item - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not relevant since no effects
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - No erythema or oedema were observed at any time point.
- Other effects:
- - no clinical signs recorded
- A red coloration was noted on the treated areas which made it difficult to score for erythema - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to skin under the test conditions described above. Skin exposure was longer (24 h) than recommended in OECD TG 404 (4 h). No dermal reactions, neither erythema nor edema, were observed.
- Executive summary:
The primary skin irritation potential of the test item was investigated according to Biological Evaluation of Medical Devices, Part10: Tests for irritation and Sensitization.
0.5 g of the test item moistened with tap water was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for twenty 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.
Therefore, it is concluded that the test item is not irritating to skin.
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:
- 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 5 (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. - 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 5 (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:
- 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.
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.
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