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Diss Factsheets

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

Referenceopen allclose all

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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).

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.