Acetic acid, C11-14-branched alkyl esters, C13-rich

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Remarks:

An existing in vivo ski irritation / corrosivity study was available.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 August 1983 to 18 October 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon biomedical sciences inc.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton dutchland inc, Denver PA
- Age at study initiation: Approximately 22 weeks
- Weight at study initiation: 3.06 to 3.5 kg
- Housing: Individual, Steel housing
- Diet (e.g. ad libitum): Purina Rabbit chow HF, ab libitum
- Water (e.g. ad libitum): Automatic watering system, ab libitum
- Acclimation period: 71 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 1 August 1983 to 18 October 1983

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Assumed 100%

Duration of treatment / exposure:

4 hours

Observation period:

60 min, 24, 48, 72 hour, 7 day

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Dorsal surface from the shoulder region to the lumbar region
- % coverage: 5 % of total body
- Type of wrap if used: Gauze patch and plastic sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 60 min, 24, 48, 72 hour, 7 day

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 60 min

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 60 m

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 60 m

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 7 d

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 60 min

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 60 m

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Dermal exposure to MRD-83-308 elicited very slight (barely perceptible) erythema in all animals. Positive dermal irritation scores were recorded for all animals at the 24 hour observation interval. By the day 7 readings only 1 animal continued to show signs of dermal irritation.

The primary irritation index for the 24 and 72 hour observations were calculated to be 0.67.

Other effects:

There were no deaths noted during this study. Five of the 6 test animals displayed an increase in body weight during the 7 day test period.

Results tables can be found in the attachment to this RSS.

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal exposure to MRD-83-308 elicited very slight (barely perceptible) erythema in all animals. Positive dermal irritation scores were recorded for all animals at the 24 hour observation interval. By the day 7 readings only 1 animal continued to show signs of dermal irritation.

The primary irritation index for the 24 and 72 hour observations were calculated to be 0.67.

Executive summary:

The primary skin irritation potential of MRD-83-306 was evaluated following its application to the clipped backs of six New Zealand white rabbits. The test material was topically administered to an intact site on the back of each animal, covered with gauze and secured with a plastic sleeve for 4 hours. After exposure was completed the plastic sleeve and gauze were removed and the test site was graded for erythema, edema and other signs of dermal irritation at approximately 60 minutes, 24, 48 and 72 hours following patch removal. Dermal readings were also made on day 7. All dermal scoring was made according to the Draize method of scoring.

 

Dermal exposure to MRD-83-306 elicited very slight (barely perceptible) erythema for all animals at the 24 hour observation interval. Only one animal showed signs of dermal irritation through to day 7.

 

Based on these findings the primary irritation index was 0.67. The primary skin irritation potential of MRD-83-306 was evaluated following its application to the clipped backs of six New Zealand white rabbits. The test material was topically administered to an intact site on the back of each animal, covered with gauze and secured with a plastic sleeve for 4 hours. After exposure was completed the plastic sleeve and gauze were removed and the test site was graded for erythema, edema and other signs of dermal irritation at approximately 60 minutes, 24, 48 and 72 hours following patch removal. Dermal readings were also made on day 7. All dermal scoring was made according to the Draize method of scoring.

 

Dermal exposure to MRD-83-306 elicited very slight (barely perceptible) erythema for all animals at the 24 hour observation interval. Only one animal showed signs of dermal irritation through to day 7.

 

Based on these findings the primary irritation index was 0.67.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

11 October 1983 to 25 October 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon biomedical sciences Inc.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Dutchland inc, Denver PA
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.48 to 3.04 kg
- Housing: Individual, Steel housing
- Diet (e.g. ad libitum): Purina rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitium
- Acclimation period: 36 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 6 September 1983 To:25 October 1983

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3160 mg/kg
- Concentration (if solution): Assumed 100%

Duration of treatment / exposure:

24 h

Observation period:

24 hours, 3, 7, 10, 14 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Dorsal surface from the shoulder region to the lumbar region
- % coverage: N/A
- Type of wrap if used: Gauze with plastic sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped
- Time after start of exposure: 24h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 24 hours, 3, 7, 10, 14 days

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

10 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

14 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

10 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

14 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

14 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

10 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

14 d

Score:

2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

10 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #2

Time point:

14 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

edema score

Basis:

animal #3

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

edema score

Basis:

animal #5

Time point:

7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #6

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #6

Time point:

7 d

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #6

Time point:

10 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritation parameter:

edema score

Basis:

animal #6

Time point:

14 d

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 14 d

Irritant / corrosive response data:

Erythema, ranging from very slight to severe, was noted in all animal.3 at 24 hours and on day 3. By day 7, very slight to well-defined erythema was observed in 5 animals and persisted in 4 animals at study termination. Very slight edema was noted in 4 animals at 24 hours. At day 7, the edema scores of 3 animals increased to slight (edges of area well-defined by definite raising). By study termination, 2 animals continued to show signs of very slight edema. Two animals exhibited eschar at the 24 hour and day 3 dermal evaluations. Desquamation was observed in all animals on day 7 and in 4 animals at termination.

Other effects:

During clinical in-life observations decreased food consumption was noted in 2 animals on day 7. One animal was observed with unthrifty coat and ano-genital staining; and another animal had alopecia noted on the left hip.

Results tables can be found in the attachment to this RSS.

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Erythema, ranging from very slight to severe, was noted in all animal.3 at 24 hours and on day 3. By day 7, very slight to well-defined erythema was observed in 5 animals and persisted in 4 animals at study termination. Very slight edema was noted in 4 animals at 24 hours. At day 7, the edema scores of 3 animals increased to slight (edges of area well-defined by definite raising). By study termination, 2 animals continued to show signs of very slight edema. Two animals exhibited eschar at the 24 hour and day 3 dermal evaluations. Desquamation was observed in all animals on day 7 and in 4 animals at termination.

Executive summary:

The acute dermal irritation potential and systemic toxicity of MRD-83-306 were evaluated in rabbits following topical occlusive exposure. Test material was the applied in a single dose of 3160 mg/kg to the clipped backs 3 male and 3 female rabbits. The test material remained in contact with the intact skin of all animals for a period of 24 hours. The amount of material remaining on the skin of each animal after the 24 hour exposure was estimated.

 

Observations were made as to the nature, onset, severity, and duration of toxicological signs 2 and 4 hours after dosing and once per day thereafter, for a total of 14 days. Dermal responses were evaluated 24 hours after topical application and on days 3, 7, 10 and 14 according to the Draize method of scoring. Body weights were recorded on the day of dosing (day 0), day 7 and 14. After the day 14 weighings and observations, all surviving rabbits were euthanized by intravenous administration of sodium pentobarbital. Dross necropsies were performed on all animals by qualified personnel.

 

There were no animal deaths during the course of the study. As compared to starting body weights, 5 or the 6 rabbits exhibited slight body weight decreases at day 7; with only 2 animals having decreased body weights at 14 days.

 

Erythema was noted in all study animals and edema was noted in 4 of the 6 animals during the course of the study. Erythema scores ranged from slight to severe, and edema ranged from very slight to slight. All animals exhibited desquamation and 2 animals had eschar during the course of the study. Slight dermal irritation persisted in 4 of the 6 animals through termination of the study.

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 October 1983 to 17 October 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Exxon biomedical sciences Inc.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazleton dutchland inc. Denver PA
- Age at study initiation: Approximately 22 weeks
- Weight at study initiation: 2.84 to 3.37 kg
- Housing: Individual, steel housing
- Diet (e.g. ad libitum): Purina rabbit chow HF, ad libitum
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 70 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21 °C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 1 August 1983 To: 17 October 1983

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Assumed 100%

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

1, 4, 24, 48, 72 hours, 4, 7 days

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

other: 4 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

6

Reversibility:

fully reversible within: 4 d

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 4 h

Score:

2

Reversibility:

fully reversible within: 4 d

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 4 d

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1 h

Score:

2

Reversibility:

fully reversible within: 24 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 4 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1 h

Score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 4 h

Score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

other: 1 h

Score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

other: 4 h

Score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

other: 1 h

Score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

other: 4 h

Score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: 1 h

Score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: 4 h

Score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

other: 4 d

Score:

1

Reversibility:

fully reversible within: 7 d

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

other: 4 h

Score:

1

Reversibility:

fully reversible within: 24 hr

Irritant / corrosive response data:

Conjunctival irritation consisting of redness ranging from some vessels definitely injected to diffuse, cimson red. Individual vessels not easily discernible was observed in the treated eyes of all animals during the 1 and 4 hour observations. Corneal ulceration was noted and confirmed using fluorescein stain in one animal at the 24 hour observation. The eyes of all rabbits were clear of any signs of irritation by day 7 and the study was terminated.

The total draize score during the study ranged from 0 to 6.

Other effects:

There were no animal deaths noted prior to study termination.

Results tables can be found in the attachment to this RSS.

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

Conjunctival irritation consisting of redness ranging from some vessels definitely injected to diffuse, cimson red. Individual vessels not easily discernible was observed in the treated eyes of all animals during the 1 and 4 hour observations. Corneal ulceration was noted and confirmed using fluorescein stain in one animal at the 24 hour observation. The eyes of all rabbits were clear of any signs of irritation by day 7 and the study was terminated.

The total draize score during the study ranged from 0 to 6.

Executive summary:

The ocular irritation potential of MRD-83-306 was evaluated following a single 0.1 ml instillation to the right eye of 6 rabbits. The treated eyes of all animals remained unwashed. Observations for signs of ocular irritation and toxicity were made as 1, 4, 24, 48 and 72 hours post-instillation and once per day on days 4 and 7. Ocular reactions were graded according to the Draize scale for scoring ocular lesions. Body weights were recorded on the day of dosing. After day 7 observations all animals were euthanised with an IV injection of T-61.

 

Ocular exposure to MRD-83-306 resulted in conjunctival irritation consisting of redness. Individual vessels not easily discernible in all animals at the 1 and 4 hour observations. Corneal ulceration was noted and confirmed using fluorescein stain at the 24 hour observation. All animals were clear of any signs of irritation by day 7.