Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-897-9 | CAS number: 68919-40-4
- 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
Based on an in vivo skin irritation test in rabbits, the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.
Based on the absence of reversibility of ocular effects
in two vivo eye irritation tests in rabbits, the registered substance is classified as a severe eye irritant (Eye Damage 1, H318) according to CLP and GHS UN criteria.
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:
- no specified (1978)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Occlusive dressing instead of non-occlusive. Half of the treated area was abraded. The animals were exposed for 24 hours instead of 4 hours and observed for 72 hours instead of 14 days.
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 4324D78
- Expiration date of the lot/batch: not specified
- Purity test date: not specified - Species:
- rabbit
- Strain:
- other: albino rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: in racks
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified
IN-LIFE DATES: not specified - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded areas
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL on each area (scarified and unscarified) - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage: 10% of the total body area was clipped free of hair the day prior the exposure. The test article was applied to a 2.0 x 2.0 cm clipped area of both intact and abraded skin
- Type of wrap if used: The 2 x 2 patch area was covered with Webril patches and the entire experimental area sealed with Blenderm Surgical Tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS : 24 and 72 jours
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Remarks:
- means score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- abraded skin
- Basis:
- mean
- Remarks:
- mean score of the 3 animals (individual scores of each animal were not reported in the study report)
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks:
- Skin reactions were still observed after the 72-hours observation period.
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on an in vivo skin irritation test in rabbits, the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.
- Executive summary:
The registered substance (product name = MIRANOL C2M Anhydrous Acid) has been tested for acute skin irritation in 3 New Zealand White rabbits. The test article, a liquid, was applied in a single dermal dose of 0.5 ml to a 2.0 x 2.0 cm clipped area of both intact and abraded skin, under an occlusive dressing for a 24-hour exposure period. Cutaneous examinations were performed at 24 hours, at removal of the dressing, and then at 72 hours.
Both on intact and abraded skin, the average score calculated over the 3 animals at 24 hours was 2.0 for erythema, and 1.0 at 72 hours. Oedema reaction was observed at 24 hours on both intact or abraded skin areas, but the reaction had cleared by 72 hours. The average score calculated over the 3 animals at 24 hours was 1.0 for both intact skin and abraded skin areas.
Considering the maximalized conditions of application (occlusive application during 24 hours), and the mild cutaneous reactions observed under these conditions, it can be concluded that the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 15 to 29 June 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were observed until Day 7 instead of Day 21
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 8803149
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyer town, PA.
- Age at study initiation: not specified (young animals)
- Weight at study initiation: 2.48 to 2.61 kg
- Housing: in suspended wire mesh cages
- Diet (e.g. ad libitum): purina rabbit pellets ad libitum
- Water (e.g. ad libitum): water at libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 5°C
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 15 June 1988 To: 22 June 1988 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL sample of the test material was placed in the conjunctival sac of the right eye of each rabbit.
- Concentration (if solution): as such - Duration of treatment / exposure:
- single adminstration on Day 0
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: recording of grade of ocular lesions (cornea, iris, conjunctivae)
Pre-screening: All rabbits used in this study received a pre-screening examination designed to detec pre-exicsting ocular irritation or corneal change.
Dose application: A 0.1 mL of test material was placed in the conjunctival sac of the right eye of each rabbit. The left eye served as control and was not treated. The lids of the treated eye were gently held together for 1 second before releasing them to prevent loss of the test material.
Observation: The ocular reactions were graded at 24, 48, 72 hours and on Days 4 and 7 using the grading system as the one described in the OECD 405 guideline. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- On the basis of the results of this in vivo study in rabbit, the registered substance is considered a severe eye irritant (Eye Damage 1, H318) according to criteria of CLP and GHS UN.
- Executive summary:
The registered substance (product name = Miranol C2M AA) has been tested for acute ocular irritation in 3 New-Zealand White rabbits according to Draize test, and in compliance with Good Laboratory Practice. The test article, a liquid, was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of the animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed at 24, 48, 72 hours after treatment, and at day 4 and 7.
Corneal opacity (score 2) was observed in all three rabbits at 24 hours. The reaction was still present in two animals at day 7 with grade 2, and with grade 1 in one animal. The mean scores (24-48-72 hours) calculated for each animal were 2.0 - 2.0 - 2.0. Iris reaction was observed between 24 hours and day 4 in one animal, and starting at day 3 in a second animal, whereas no reaction was observed in the third one. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 0.0 - 0.3.
Conjunctival redness (score 2 to 3) and chemosis (score 1 to 3) were observed and persisted until day 7 in all three animals. The mean scores (24-48-72 hours) calculated for each animal were 3.0 - 2.0 – 2.0 for redness, and 2.7 – 2.0 - 1.3 for chemosis.
In addition, ocular discharge was observed all three animals throughout the observation period.
On the basis of these results the registered substance is considered a severe eye irritant (Eye Damage 1, H318) according to criteria of CLP and GHS UN.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were observed until Day 7 instead of Day 21
- Principles of method if other than guideline:
- Draize method
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 4324D78
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
not specified
ENVIRONMENTAL CONDITIONS
not specified - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL sample of the test material was instilled into the right eye of each rabbit.
- Concentration (if solution): as such - Duration of treatment / exposure:
- single adminstration on Day 0
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: recording of grade of ocular lesions (cornea, iris, conjunctivae) .
Dose application: A 0.1 mL of test material was instilled into the right eye of each rabbit. The left eye served as control and was not treated.
Observation: The ocular reactions were graded at 24, 48, 72 hours and on Days 4 and 7 using the grading system as the one described in the OECD 405 guideline. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- On the basis of the results of this in vivo study in rabbit (conjunctivae redness not fully reversible within 7 days), the registered substance is considered a severe eye irritant (Eye Damage 1, H318) according to criteria of CLP and GHS UN.
- Executive summary:
The registered substance (product name = Miranol C2M AA) has been tested for acute ocular irritation in 3 albino rabbits according to Draize test. The test article, a liquid, was instillated as such in a single dose of 0.1 ml into the right eye of the animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed at 24, 48, 72 hours after treatment, and at and 7.
No corneal opacity nor iris reaction were reported in any animals.
Conjunctival redness (score 1 to 2) and chemosis (score 1 to 3) were observed in all three animals. Conjunctival redness persited until day 7 in one animal. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 1.7 – 1 for redness, and 0.7 – 2.0 - 0.3 for chemosis.
In addition, ocular discharge was observed all three animals but reversed at day 7.
On the basis of these results (absence of reversibility of conjunctival redness in one animal) the registered substance is considered a severe eye irritant (Eye Damage 1, H318) according to criteria of CLP and GHS UN.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One study of Klimish score 2 is available to assess the skin irritation potential (Levenstein, 1978). In this study, the registered substance (product name = MIRANOL C2M Anhydrous Acid) has been tested for acute skin irritation in 3 New Zealand White rabbits. The test article, a liquid, was applied in a single dermal dose of 0.5 ml to a 2.0 x 2.0 cm clipped area of both intact and abraded skin, under an occlusive dressing for a 24-hour exposure period. Cutaneous examinations were performed at 24 hours, at removal of the dressing, and then at 72 hours.
Both on intact and abraded skin, the average score calculated over the 3 animals at 24 hours was 2.0 for erythema, and 1.0 at 72 hours. Oedema reaction was observed at 24 hours on both intact or abraded skin areas, but the reaction had cleared by 72 hours. The average score calculated over the 3 animals at 24 hours was 1.0 for both intact skin and abraded skin areas.
Considering the maximalized conditions of application (occlusive application during 24 hours), and the mild cutaneous reactions observed under these conditions, it can be concluded that the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.
Two study of Klimish score 2 are available to asses the eye irritation potential (Terrell, 1988; Levenstein, 1978). Terrell study was selected as key study as it has been conducted following the Good Laboratory Practise. In this study, the registered substance (product name = Miranol C2M AA) has been tested for acute ocular irritation in 3 New-Zealand White rabbits according to Draize test. The test article, a liquid, was instillated as such in a single dose of 0.1 ml into the conjunctival sac of the right eye of the animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed at 24, 48, 72 hours after treatment, and at day 4 and 7.
Corneal opacity (score 2) was observed in all three rabbits at 24 hours. The reaction was still present in two animals at day 7 with grade 2, and with grade 1 in one animal. The mean scores (24-48-72 hours) calculated for each animal were 2.0 - 2.0 - 2.0. Iris reaction was observed between 24 hours and day 4 in one animal, and starting at day 3 in a second animal, whereas no reaction was observed in the third one. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 0.0 - 0.3. Conjunctival redness (score 2 to 3) and chemosis (score 1 to 3) were observed and persisted until day 7 in all three animals. The mean scores (24-48-72 hours) calculated for each animal were 3.0 - 2.0 – 2.0 for redness, and 2.7 – 2.0 - 1.3 for chemosis. In addition, ocular discharge was observed all three animals throughout the observation period.
In the supporting study (Levenstein, 1978), the registered substance (product name = Miranol C2M AA) has been tested for acute ocular irritation in 3 albino rabbits according to Draize test. The test article, a liquid, was instillated as such in a single dose of 0.1 ml into the right eye of the animal. The left eye remained untreated and served as a control. The eyes were not rinsed. Ocular examinations were performed at 24, 48, 72 hours after treatment, and at and 7.
No corneal opacity nor iris reaction were reported in any animals.
Conjunctival redness (score 1 to 2) and chemosis (score 1 to 3) were observed in all three animals. Conjunctival redness persited until day 7 in one animal. The mean scores (24-48-72 hours) calculated for each animal were 1.0 - 1.7 – 1 for redness, and 0.7 – 2.0 - 0.3 for chemosis. In addition, ocular discharge was observed all three animals but reversed at day 7.
On the basis of the results of these study and considering the absence of reversibility of ocular reaction 7 days after exposure, the registered substance is considered a severe eye irritant (Eye Damage 1, H318) according to criteria of CLP and GHS UN.
Justification for classification or non-classification
Based on an in vivo skin irritation test in rabbits, the registered substance is not be classified as a skin irritant according to CLP and GHS UN criteria.
Based on the absence of reversibility of ocular effects in two in vivo eye irritation tests in rabbits, the registered substance is classified as a severe eye irritant (Eye Damage 1, H318) according to CLP and GHS UN criteria.
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.