Registration Dossier
Registration Dossier
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EC number: 947-155-9 | CAS number: -
- 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
MTDID 44428 was tested in an in vivo skin irritation study, in vitro skin irritation study and an ex vivo eye irritation study. The results of the studies were:
Skin irritation:
in vivo: Irritating when tested according to OECD 404.
in vitro: Not irritating when tested according to OECD 439.
Eye irritation: Not irritating when tested according to OECD 437.
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:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- No data
- Deviations:
- no
- Remarks:
- No deviations ocurred that impacted the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 11
- Purity, including information on contaminants, isomers, etc.: 99.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Kept in a room with controls set to maintain 18°C to 24°C
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
None, dosed neat.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
: The test article was dosed neat. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Inc.
- Age at study initiation: 1.5
- Weight at study initiation: 3.9-4.3 kg
- Housing: Individually housed in stainless steel cages elevated above corncob bedding.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified High Fiber Rabbit Diet 5325. Approximately 150 g/day was offered during the study.
- Water (e.g. ad libitum): Tap water, treated by reverse osmosis and UV irradiation, ad libitum.
- Acclimation period: At least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22 C
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 July, 2019 To: 22 July, 2019 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
NEGATIVE CONTROL : No treatment
POSITIVE CONTROL : None - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Observations were made at 24, 48 and 72 hours post patch removal and 4, 7, 14, 18 and 21 days post-removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm area of skin
- Type of wrap if used: 2-ply gauze patch secured in place with surgical porous tape. The patches were overwrapped with a gauze binder and secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of 4 hours, the bandages were removed and the sites wiped with disposable paper towels moistened with deionized water
- Time after start of exposure: 4 hours.
OBSERVATION TIME POINTS
Observations were made at 24, 48 and 72 hours post patch removal and 4, 7, 14, 18 and 21 days post-removal.
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 5 days
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 8 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 15 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 19 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 22 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 5 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 8 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 15 days
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 19 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 22 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 5 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 8 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 15 days
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 19 days
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 22 days
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 22 days
- Remarks:
- 22 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- No edema was observed in animal 1 at any observation point through 22 days during the study
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- No edema was observed in animal 2 at any observation point through 22 days during the study
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- No edema was observed in animal 3 at any observation point through 22 days during the study
- Irritant / corrosive response data:
- Average erythema individual scores (24, 48, and 72 hours) were 1.67, 2.0, and 1.33. Significant erythema persisted during days 15-19 for all three animals. No edema was observed. The Primary Irritation Index (PII) was 1.3.
- Other effects:
- - Other adverse local effects:
Skin flaking was overved in animal 1 at Day 15.
- Other adverse systemic effects: None. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The Primary Irritation Index (PII) was 1.3. The 24, 48, and 72 hours erythema scores indicate a Cat. 3. However, given the irritation seen at days 15-19, MTDID 44430 will be classified as a Skin 2 per GHS and CLP.
- Executive summary:
The skin irritation potential of MTDID 44428 was examined in a study conducted according to OECD 404 in compliance with OECD GLP. New Zealand White rabbits (N = 3) received a single, 4-hour, semi-occluded exposure of 0.5 mL MTDID 44428, which was applied to clipped, unabraded skin. Application sites were evaluated at approximately 30-60 minutes and 24, 48, and 72 hours after patch removal, and 4, 7, 14, 18, and 21 days after removal (Days 5, 8, 15, 19, and 22, respectively). There were no deaths or remarkable body weight changes noted during the study. Average erythema individual scores (24, 48, and 72 hours) were 1.67, 2.0, and 1.33. Significant erythema persisted during days 15-19 for all three animals. No edema was observed. The Primary Irritation Index (PII) was 1.3. The 24, 48, and 72 hours erythema scores indicate a Cat. 3. However, given the irritation seen at days 15-19, MTDID 44430 will be classified as a Skin 2 per GHS and CLP.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- no
- Remarks:
- No deviations ocurred that negatively impacted the integrity of the study.
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 10
- Purity: 99.61%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: No data
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): None, dosed neat. - Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Three-dimensional reconstructed epidermal tissue model composed of human keratinocytes cultivated in vitro to resemble human epidermis.
- Cell source:
- other: No data
- Details on animal used as source of test system:
- SOURCE ANIMAL
: No data
- Justification for test system used:
- EpiDerm is recommended as a test tissue per OECD 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm
- Tissue batch number(s): No data
- Production date: No data
- Shipping date: No data
- Delivery date: 01 December, 2015
- Date of initiation of testing: 02 December, 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 C
- Temperature of post-treatment incubation (if applicable): 37 C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: With a constant gentle stream of DPBS from a wash bottle. The tissue culture inserts were filled and emptied approximately 20 times.
- Observable damage in the tissue due to washing: None reported.
- Modifications to validated SOP: None reported.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: No data
- Incubation time: 3 hours.
- Spectrophotometer: No data
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues / killed tissues : No data
- N. of replicates : No data
- Method of calculation used: No data
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3 replicates, one independent experiment.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be an irritant if the mean tissue viability is less than or equal to 50% following a 60 minute exposure to the test article. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 uL
NEGATIVE CONTROL : DPBS
- Amount(s) applied (volume or weight): 30 uL
POSITIVE CONTROL : 5% SDS
- Amount(s) applied (volume or weight): 30 uL
- Concentration (if solution): 5% SDS - Duration of treatment / exposure:
- 60 minute exposure to the test article.
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 89
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 95
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3
- Value:
- 98
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: None reported.
- Direct-MTT reduction: None reported.
- Colour interference with MTT: None reported.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The lab has demonstrated proficiency in running OECD 439.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- After a 60 -minute exposure period and a 42 -hour post-exposure period, the viability of the test article was 94%. MTDID 44428 is therefore considered to be not irritating to the skin.
- Executive summary:
The dermal irritation potential of MTDID 44428 was evaluated in EpiDerm per OECD 439. Human reconstructed epidermal tissues (n=3) were exposed to 30 uL of the test article (neat) for a 60 minute exposure period. Following the exposure period, the tissues were washed with DPBS and incubated for 42 hours. Following incubation, the tissue viability was measured via MTT assay and compared to the negative control. After a 60 -minute exposure period and a 42 -hour post-exposure period, the mean viability of the test article was 94% (89, 95, and 98%). MTDID 44428 is therefore considered to be not irritating to the skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- Remarks:
- No deviations ocurred that negatively impacted the integrity of the study results.
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 11
- Purity, including information on contaminants, isomers, etc.: 99.7%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Kept in a room with controls set to maintain 18°C to 24°C
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding):
None, dosed neat.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
: The test article was dosed neat. - Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Bovine eyes (greater than 35 weeks of age) were obtained from an abattoir and transported to MB Research in a refrigerated container containing Hanks’ Balanced Salt Solution (HBSS) with penicillin-streptomycin on 20 Jun 2019, within 24 hours of harvest.
- Number of animals: No data
- Characteristics of donor animals (e.g. age, sex, weight): At least 35 weeks old.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): See 'Source' field.
- Time interval prior to initiating testing: The study began the same day that the eyes were delivered to the lab.
- Indication of any existing defects or lesions in ocular tissue samples: The eyes were examined after receipt from the abattoir. Any cornea with visible evidence of neovascularization, pigmentation, opacity or scratches was discarded
- Indication of any antibiotics used: See 'source' field.
- Selection and preparation of corneas: Corneas free of visible defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The excised corneas were then placed in a container of fresh HBSS.
- Quality check of the isolated corneas: The dissected corneas were mounted in specially designed holders (MC2, formerly Electro-Design – the manufacturer of the Op-KIT opacitometer) that were separated into anterior and posterior chambers and filled separately. Each cornea was mounted allowing the epithelium of the cornea to project into the anterior chamber. The posterior chamber was filled with MEM solution ensuring contact with the endothelium. The anterior chamber was filled with MEM solution, ensuring contact with the epithelium. Each cornea was visually inspected again to ensure there were no defects - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
VEHICLE: None - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- NUMBER OF REPLICATES
: 3
NEGATIVE CONTROL USED : Minimal Essential Media
SOLVENT CONTROL USED: NA
POSITIVE CONTROL USED : 100% ethanol
APPLICATION DOSE AND EXPOSURE TIME : 0.75 mL for 10 minutes
TREATMENT METHOD: Closed chamber
POST-INCUBATION PERIOD: yes, 2 hours.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 2 washing steps 10 minutes after the start of exposure.
- POST-EXPOSURE INCUBATION: 2 hours.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: OP-KIT opacitometer (Electro-Design Corporation, RIOM, France)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: The decision criteria described in OECD 437 was utilized. - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- -1.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- -1.34
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein leakage
- Remarks:
- Corrected Mean Optical Density (Permeability)
- Run / experiment:
- Mean
- Value:
- 0.003
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None
DEMONSTRATION OF TECHNICAL PROFICIENCY: The lab is proficient in running OECD 437.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Negative control IVIS was 2.90.
- Acceptance criteria met for positive control: The In Vitro Irritancy Score (IVIS) of ethanol (positive control), 15.83, exceeded two standard deviations of the historical mean IVIS (range: 15.97 to 40.84).
Although the IVIS of the positive control exceeded two standard deviations of the historical mean range, the test is considered valid as it still demonstrated the anticipated outcome of bovine corneas exposed to 100% ethanol for a 10-minute exposure: a mild to moderately irritating, non-corrosive response. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study (IVIS = -1.30), MTDID 44428 is not irritating in the Bovine Corneal Opacity and Permeability Test (BCOP).
- Executive summary:
The eye irritation potential of MTDID 44428 was evaluated in the Bovine Corneal Opacity and Permeability Test (BCOP) according to OECD 437 and in compliance with OECD GLP. MTDID 44428 (0.75 mL) was tested neat in triplicate concurrently with Minimal Essential Medium (negative control) and 100% ethanol (positive control). Corneas were exposed to the test article and controls using the closed chamber method for 10 minutes. Following a washing phase, the corneas were incubated for a 2 hour post-exposure period at 32 C. A measurement of opacity was taken with each treated cornea compared to the blank supplied with the OP-KIT. This reading was used in the final IVIS calculations. Immediately following the two-hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 ml of 0.4% sodium fluorescein solution in Dulbecco's phosphate buffered saline (PBS). Each holder was then returned to the 32 (±1)°C incubator in a horizontal position (anterior chamber facing upward) ensuring contact of the fluorescein with the cornea. After 90 (±5) minutes, the fluid from the posterior chamber of each corneal holder was removed and the amount of dye that passed through the cornea (permeability) was measured as the optical density at 490 nm (i.e., the OD490 nm) by spectrophotometer. The In Vitro Irritancy Score (IVIS) for MTDID 44428 was -1.30, negative control was 2.90, and the positive control was 15.83. Based on the results of the study (IVIS = -1.30), MTDID 44428 is not irritating in the Bovine Corneal Opacity and Permeability Test (BCOP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Based on the results of the studies, MTDID 44428 is classified as Skin 2 per GHS and CLP and not classified for eye irritation.
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