Tetravinylsilane

Endpoint summary

Description of key information

Skin corrosion/irritation:

Two in vitro and one in vivo studies are available for the submission substance:

Skin corrosion in vitro

The potential of the test material to cause skin corrosivity was investigated in an RhE model (EPI-200SCT (MatTek)) according to OECD 431. Mean relative viabilities for the cultures exposed to the test material were 98.3% and 99.0% following exposure for 3 minutes and 60 minutes, respectively. The test item is not considered to be corrosive to skin on the basis of this study.

 

Skin irritation in vitro:

The potential of the test material to cause skin irritation was investigated in an RhE model (EPI-200SCT (MatTek)) according to OECD 439. The mean relative viability for the culture exposed to the test material was 80.6%. The test item is not considered to be a skin irritant on the basis of this study.

Skin corrosion/irritation in vivo:

The study was performed to assess the acute dermal irritation/corrosion of test item in rabbits in accordance with OECD 404. Individual scores of erythema/eschar and oedemas were all 0 for three treated sites at 1, 24, 48 and 72 hours after patch removal. The mean scores of erythema/eschar and oedemas at 24, 48 and 72 hours were all 0 for three test sites after patch removal.

The test item was considered to not be irritating to skins in rabbits.

 

Eye irritation:

One in vitro and on in vivo studies are availabke.

Eye irritation in vitro

The potential of the test material to cause eye irritation was investigated in an RhCE model (EpiOcular) (MatTek)) according to OECD 492. The mean relative viability for the culture exposed to the test material was 74.4%. The mean viability of the cultures exposed to the test material was >60%; therefore classification for eye irritation is not required.

Eye irritation in vivo:

The study was performed to assess the acute eye irritation/corrosion of test item in rabbits in accordance with OECD 405. Three male rabbits were used for the study. Each animal was administered about 0.1 mL of the test item into right eye. Untreated left eye served as the control.

Individual and mean scores of Cornea Opacity, Iris, Conjunctival Redness and Chemosis were all 0 for three treated eyes at approximately 24, 48, 72 hours after administration. Therefore, the test item was considered to not be irritating to eye in rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From 2017-09-21 to 2017-11-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

July 29, 2016

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Lot No.: 707001
Purity: 98.6%

Test system:

human skin model

Remarks:

EPI-200SCT (MatTek)

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

RhE model approved under the test guideline

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Name: EPI-200SCT (MatTek)
- Epiderm Tissue lot: 27124, manufactured 21st September 2017
- Receipt Date: 25th September 2017
- Storage: 1-10°C
- Culture conditions: 37°C (5% CO2)
- Buffer solution: PBS without Ca2+ and Mg2+

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature for 3-minute exposure, 37 °C for 60-minute exposure
- Temperature of post-treatment incubation: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the exposure, each tissue was rinsed approximately twenty times with PBS(-).Inside and outside of the tissue were wiped. The tissue inserts were placed into new 24-well plates (Corning) filled with 300 μL/well of fresh medium. Remaining PBS(-) was completely removed from the tissue surface.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mL/well, 1 mg/mL MTT solution
- Incubation time: 180 ± 5 minutes
- Spectrophotometer: Multimode Microplate Reader (FLUOstar OPTIMA, BMG LABTECH)
- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: 2

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

50 µL

Duration of treatment / exposure:

3 minutes and 60 minutes

Duration of post-treatment incubation (if applicable):

180 minutes

Number of replicates:

2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3 minute exposure

Value:

98.3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

relative viability 100.0%

Positive controls validity:

valid

Remarks:

relative viability 10.7%

Remarks on result:

other: not corrosive

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60-minute exposure

Value:

99

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

relative viability 100.0%

Positive controls validity:

valid

Remarks:

relative viability 1.6%

Remarks on result:

other: not corrosive

Other effects / acceptance of results:

As a result of tissue-binding test in the 3-minute and 60-minute exposures, the staining ratios of the tissue treated by the test substance were 0.3% and 0.4%, respectively, and they were below 5%. Therefore, the ODs were not corrected.

The acceptability criteria were met:
OD of the negative control >=0.8 and <=2.8
Mean viability for the positve control (60-minute incubation) <15%
Coefficient of variation for the test substance viability <30%

Summary of results

	3-minute exposure			60-minute exposure
	Mean viability	SD	CV	Mean viability	SD	CV
Negative control	100%	0.99	1.0	100%	4.53	4.5
Test material	98.3%	2.62	2.7	99.0%	3.96	4.0
Positive control	10.7%	0.85	7.9	1.6%	0.07	4.4

Interpretation of results:

GHS criteria not met

Conclusions:

The test material is not considered to be corrosive to skin on the basis of this study.

Executive summary:

The potential of the test material to cause skin corrosivity was investigated in an RhE model (EPI-200SCT (MatTek)) according to OECD 431.

Prior to the main test, the test material was assessed for the potential to directly reduce MTT. The results of this study were negative; therefore an MTT interference test was not conducted. There was no evidence of reactivity of the test material with the nylon mesh. A tissue binding study was also negative. In the main test, 50 µL of the test material, negative control (distilled water) or positive control (potassium hydroxide, 8N) were applied to duplicate cultures for 3 and 60 minutes. After a post-exposure period of 180 minutes, cell viability was assessed using MTT reduction. Mean relative viabilities for the cultures exposed to the test material were 98.3% and 99.0% following exposure for 3 minutes and 60 minutes, respectively.

Therefore the test item is not considered to be corrosive to skin on the basis of this study.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From 2017-09-21 to 2017-11-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

July 28, 2015

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Batch No.: 707001
Purity: 98.6%

Test system:

human skin model

Remarks:

Epiderm(TM)SIT (EPI-200)

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Model validated under OECD 439

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Epiderm(TM)SIT (EPI-200), MatTek
- Tissue batch number(s): 27124
- Production date: 21 September 2017
- Delivery date: 25 September 2017
- Date of initiation of testing: 25 September 2017
- Storage: 1-10°C
- Culture conditions: 37°C (5% CO2)
- Buffer: PBS (Ca and Mg-free)

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C for first 35 ± 1 min and at room temperature for remaining exposure time
- Temperature of post-treatment incubation: 37°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: After the exposure, each tissue was rinsed fifteen times with PBS (-). After the 15th rinse, tissue inserts were completely submerged three times in 150 mL of PBS (-). Finally, tissue inserts were rinsed once from inside and outside with PBS (-). Remaining PBS (-) was removed from inside and outside of tissue insert with a sterile cotton swab. Tissue inserts were transferred into the upper wells of new 6-well plates containing 0.9 mL of fresh medium. PBS (-) on the surface of tissues were removed with a sterile cotton swab.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 180 ± 5 minutes
- Spectrophotometer: Multimode Microplate Reader (FLUOstar OPTIMA, BMG LABTEC)
- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: Triplicate


PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

30 µL

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

24 hours

Number of replicates:

The test material, negative and positve controls were tested in triplicate

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Mean

Value:

80.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

mean relative viability 100.0%

Positive controls validity:

valid

Remarks:

mean relative viability 1.9%

Remarks on result:

other:

Remarks:

not classified for irritation

Other effects / acceptance of results:

The test met the following acceptability criteria:
Mean OD for the negative control >=1.0 and <=2.5
Mean viability for the positive control <=20%
SDs for each group (triplicate cultures) <18%

Summary of results

	OD [mean]	Mean relative viability	SD
Negative control (PBS)	2.385 2.338 2.322 [2.348]	100%	1.4
Test material	1.877 1.594 2.204 [1.892]	80.6%	13.0
Positive control (0.5% SDS)	0.046 0.041 0.045 [0.044]	1.9%	0.2

OD: optical density

Interpretation of results:

GHS criteria not met

Conclusions:

The test material does not require classification as a skin irritant on the basis of this study.

Executive summary:

The potential of the test material to cause skin irritation was investigated in an RhE model (EPI-200SCT (MatTek)) according to OECD 439. Prior to the main test, the test material was assessed for the potential to directly reduce MTT. The results of this study were negative; therefore an MTT interference test was not conducted. There was no evidence of reactivity of the test material with the nylon mesh. A tissue binding study was also negative.

In the main test, 30 µL of the test material, negative control (PBS) or positive control (5% SDS solution) were applied to triplicate cultures for 60 minutes. After a post-exposure period of 24 hours, cell viability was assessed using MTT reduction. The mean relative viability for the culture exposed to the test material was 80.6%.

The test item is not considered to be a skin irritant on the basis of this study.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2019-06-03 to 2019-06-07

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:

2015

Deviations:

yes

Remarks:

Housing room temperature and humidity has small deviations from Guideline, but not affect the quality and integrity of the study.

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: Japanese white

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shenyang Tenghua Biotechnology Co., Ltd.
- Age at study initiation: 97-108 days
- Weight at study initiation: 2344.6-2407.8 g
- Housing: individually raised in suspended, stainless steel cages (W 40 cm× L50 cm×H40 cm) on cage racks (L167 cm×W70cm×H171 cm)
- Diet: pellet rabbit diet, ad libitum
- Water: ad libitum
- Acclimation period: 7-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-25.1
- Humidity (%): 49-77
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL test item

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

Initial Test: 1
Confirmatory Test: 2

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm× 2.5 cm
- Dosing: A dose 0.5 mL of the test item was applied to the gauze patch (2.5 cm × 2.5 cm). The test and control patches were applied to the appointed and depilated skin.
- Type of wrap: All animals were wrapped using elastic bandage and medical paper tape to form a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: Patches were removed at the end of the exposure period. The residual test substance was gently wiped off the application site by cotton moistened with tepid water. Care was taken not to alter the existing response or the integrity of the epidermis.
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
- Clinical Observations:
All animals were observed for clinical signs once daily throughout the study.
- Skin Reactions Examination:
The skin sites of each animal were examined and recorded for signs of skin reaction immediately, at approximately 1, 24, 48 and 72 hours after patch removal.
- Body Weights:
Individual animal body weights were recorded within 24 hours after arrival, on the day of dosing and on the completion day of the final observation of dermal irritant symptoms.

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

erythema score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

The test item sites did not show any evidence of adverse skin reactions such as erythema and oedema immediately, at approximately 1, 24, 48 and 72 hours after patch removal of the test item.
There was no observable abnormality in skin reaction examinations for three control sites at all observation intervals after patch removal of the test item.

Other effects:

- Clinical Observations:
No abnormal signs or symptoms were observed in three animals throughout the course of the study.
- Body Weights:
The body weights of all animals showed growth trends during the observation periods.

Skin Reactions Grading:

No.	Erythema				Oedema
	24h	48h	72 h	Mean	24h	48h	72 h	Mean
1100	0	0	0	0	0	0	0	0
1101	0	0	0	0	0	0	0	0
1102	0	0	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was considered to not be irritating to skins in rabbits.

Executive summary:

The study was performed to assess the acute dermal irritation/corrosion of test item in rabbits in accordance with OECD 404.

Three male rabbits were used for the study. 0.5 mL of test item was applied to the right side of back skin of each animal for an exposure period of 4 hours. The untreated skin on the left back area of the animal served as the control.

No abnormal signs or symptoms were observed in three animals throughout the course of the study.

The body weights of all animals showed growth trends during the observation periods.

Individual scores of erythema/eschar and oedemas were all 0 for three treated sites at 1, 24, 48 and 72 hours after patch removal. The mean scores of erythema/escharand oedemasat24,48 and 72 hourswereall0 for threetestsitesafter patch removal.

The test item was considered to not be irritating to skins in rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From 2017-09-21 to 2017-11-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

July 28, 2015

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Batch No.: 707001
Purity: 98.6%

Species:

human

Details on test animals or tissues and environmental conditions:

The study used the MatTek reconstructed human cornea-like epithelium model (EpiOcular, Lot 20993)

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50 µL

Duration of treatment / exposure:

30 minutes

Number of animals or in vitro replicates:

The test material, postive and negative controls were investiagted in duplicate.

Details on study design:

- RhCE tissue construct used, including batch number
EpiOcular(TM)EIT (OCL-200): MatTek
Lot No.: 20993
Manufacture date: 21 September 2017
Recepit Date: 25 September 2017
Storage: 1-10°C
Culture conditions: 37°C (5% CO2)
Buffer: PBS (Ca and Mg-free)-

- Details of the test procedure used:
Pre-incubation:
Tissue inserts were placed in 6-well plate (Asahi Glass) filled with 1 mL/well of the medium and incubated for 60 ±5 minutes.
The medium was aspirated and 1 mL/well of the fresh medium was added to each well. Then, the tissue inserts were incubated for 16-24 hours.
Exposure of the test substance:
Twenty microliters of PBS (-) was added onto each tissue surface at 1 minute interval. Two tissues were treated at once. Each plate was incubated until 30 ± 2 minutes was completed for the first exposed tissue in each plate.
Fifty microliters of the control substances and the test substance were applied onto each tissue surface at 1 minute interval. Two tissues were treated at once. Each plate was incubated until 30 ± 2 minutes was completed for the first exposed tissue in each plate.
Rinsing and post-incubation:
After the incubation, each tissue insert was completely submerged three times about 100 mL of PBS (-). Two tissues were treated at once. Rinsing was repeated twice further. PBS (-) was removed from the tissue surface.
The tissue inserts were transferred into a 12-well plate (Corning) filled with 5 mL/well of the fresh medium and soaked 12 ±2 minutes.
The tissue inserts were transferred into 6-well plates filled with 1 mL/well of the fresh medium and incubated for 120 ±15 minutes.

- Doses of test chemical and control substances used : 50 μL

- Duration and temperature: Pre-incubation: 16-24 hours at 37 °C; Exposure: 30±2 min at 37 °C; post-incubation: 120±15 min at 37 °C

- Number of tissue replicates used per test chemical and controls (positive control, negative control) : 2

- Measuring of optical density (OD):
OD was measured spectrophotometrically using Multimode Microplate Reader (FLUOstar OPTIMA, BMG LABTECH) at 570 nm.

- Judgment criteria of the results:
Eye irritation was judged as irritant if mean cell viability ≤ 60%, and non-irritant if mean cell viability > 60%.

- Acceptable criteria of the test:
a) Mean OD in the negative control substance group is> 0.8 and < 2.5.
b) Mean cell viability in the positive control substance group is < 50%.
c) Differences of two tissue cell viabilities in each treatment group are < 20%.

- Positive and negative control means and acceptance ranges based on historical data Negative control: OD: mean ± SD: 1.248 ±0.1772, range:0.716 – 1.780
Positive control: OD: mean ± SD: 0.403 ±0.0957, range:0.116 – 0.690; Cell viability: : mean ± SD: 32.3 ±6.57 %, range: 12.6 – 52.1 %

Irritation parameter:

other:

Remarks:

relative viability %

Run / experiment:

Mean

Value:

74.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

Relative viability 100.0%

Positive controls validity:

valid

Remarks:

Relative viability 49.3%

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The acceptability criteria were met:
Mean OD for the negative control: 1.593
Mean viability for the positive control: 49.3%
Differences in each treatment group: 11.4%, 8.5%, 7.9%, respectively for negative, positive control and test substance.

Summary of results

	OD [mean]	Mean relative viability	Difference (%)
Negative control (distilled water)	1.502, 1.684 [1.593]	100%	11.4%
Test material	1.135, 1.260 [1.198]	75.2%	8.5%
Positive control (methyl acetate)	0.852, 0.717 [0.785]	49.3%	7.9%

OD: optical density

Interpretation of results:

GHS criteria not met

Conclusions:

The test item does not require classification for eye irritation in any category based on the results of this study.

Executive summary:

The potential of the test material to cause eye irritation was investigated in an RhCE model (EpiOcular) (MatTek)) according to OECD 492. Prior to the main test, the test material was assessed for the potential to directly reduce MTT. The results of this study were negative; therefore an MTT interference test was not conducted. In the main test, 50 µL of the test material, negative control (distilled water) or positive control (methyl acetate) were applied to duplicate cultures for 30 minutes. After a post-exposure period of 2 hours, cell viability was assessed using MTT reduction. The mean relative viability for the culture exposed to the test material was 74.4%. The mean viability of the cultures exposed to the test material was >60%; therefore classification for eye irritation is not required.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2019-06-04 to 2019-06-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2017

Deviations:

yes

Remarks:

Housing room temperature and humidity has small deviations from Guideline, but not affect the quality and integrity of the study.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch No.: 707001
Purity: 98.5%

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Shenyang Tenghua Biotechnology Co., Ltd.
- Age at study initiation: 98-115 days
- Weight at study initiation: 2373.6-2517.0 g
- Housing: individually raised in suspended, stainless steel cages (W 40 cm× L50 cm×H40 cm) on cage racks (L167 cm×W70cm×H171 cm)
- Diet: pellet rabbit diet, ad libitum
- Water: ad libitum
- Acclimation period: 8-15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-25.1
- Humidity (%): 48-77
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL test item

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Initial Test: 1
Confirmatory Test: 2

Details on study design:

ADMINISTRATION METHOD
- Dosing: The rabbits were held firmly but gently until quiet. 0.1 mL of the test item was placed in the conjunctiva! sac of right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were gently held together for approximately one second in order to prevent loss of the material. The left eye remained untreated and served as a control.
- Dosing Frequency: Each animal was dosed once.
- Dosing Time: In the morning.
The time interval between initial test and confirmatory test was about 6 days

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Fluorescein sodium and slit lamp

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal: #1, #2 & #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Three treated eyes showed no abnormal symptoms in cornea, iris and conjunctivae and there were no any other lesions in three treated eyes at 1 hour and 24, 48, 72 hours after administration
There was no any retention of fluorescein for three treated eyes and three control eyes approximately 24 hours prior to dosing and at approximately 24 hours after administration.

Other effects:

- Clinical Observations:
No adverse systemic effects were observed in any animals during the study.
- Body Weights
The body weights of all animals showed growth trends during the observation periods.

Eye Reaction Scoring:

No.	Conjunctivae				Chemosis				Cornea opacity				Iris
	24h	48h	72h	Mean	24h	48 h	72 h	Mean	24h	48h	72 h	Mean	24h	48h	72 h	Mean
1100	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1101	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1102	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Interpretation of results:

other: not classified

Conclusions:

The test item was considered to not be irritating to eye in rabbits.

Executive summary:

The study was performed to assess the acute eye irritation/corrosion of test item in rabbits in accordance with OECD 405.

Three male rabbits were used for the study. Each animal was administered about 0.1 mL of the test item into right eye. Untreated left eye served as the control.

No adverse systemic effects were observed in any animals during the study.

Three treated eyes showed no abnormal symptoms in cornea, iris and conjunctivae and there were no any other lesions in three treated eyes at 1 hour and 24, 48, 72 hours after administration

There was no any retention of fluorescein for three treated eyes and three control eyes approximately 24 hours prior to dosing and at approximately 24 hours after administration.

Individual and mean scores of Cornea Opacity, Iris, Conjunctival Redness and Chemosis were all 0 for three treated eyes at approximately 24, 48, 72 hours after administration.

The body weights of all animals showed growth trends during the observation periods

The test item was considered to not be irritating to eye in rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin corrosion in vitro: OECD 431, not corrosive

Skin irritation in vitro: OECD 439, not irritating

Skin irritation in vivo: OECD 404, mean scores of erythema/eschar and oedemas at 24, 48 and 72 hours were all 0 for three test sites after patch removal.

According to Regulation (EC) No 1272/2008, section 3.2.2 and Table 3.2.2, this substance should not be classified for this endpoint.

 

Eye irritation in vitro: OECD 492: not irritating 

Eye irritation in vivo: OECD 405, mean scores of Cornea Opacity, Iris, Conjunctival Redness and Chemosis were all 0 for three treated eyes at approximately 24, 48, 72 hours after administration.

 

According to Regulation (EC) No 1272/2008, section 3.3.2 and table 3.3.1, this substance should not be classified for this endpoint.