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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
N/A to 1983-08-12
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed with methods similar to OECD Guideline 405. However, limited information was provided on the test substance, eyes were washed 4 seconds after exposure and observations were only made up until Day 7.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited information was provided on the test substance, eyes were washed 4 seconds after exposure and observations were only made up until Day 7.
Principles of method if other than guideline:
N/A
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 3-mercaptopropionate
EC Number:
220-912-4
EC Name:
Methyl 3-mercaptopropionate
Cas Number:
2935-90-2
Molecular formula:
C4H8O2S
IUPAC Name:
methyl 3-sulfanylpropanoate
Details on test material:
- Name of test material (as cited in study report): methyl 3-mercaptopropionate
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratory Animals, Inc.
- Age at study initiation: young adult
- Weight at study initiation: 2174-2451 g
- Housing: Animals were housed individually.
- Diet (e.g. ad libitum): ad libitum (Purina Lab Rabbit Chow)
- Water (e.g. ad libitum): ad libitum (tap)
- Acclimation period: minimum of one week


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): Every attempt was made to maintain temperatures at 70+/-4 degrees F.
- Humidity (%): Every attempt was made to maintain a relative humidity of 40-60 %.
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: N/A To: N/A

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye of each animal served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the undiluted test substance was place in the lower conjunctival sac of the left eye of each animal.
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of treatment / exposure:
Single application. The treated eyes were held closed for 4 seconds after instillation, followed by washing.
Observation period (in vivo):
7 days (Eyes were examined at 1, 24, 48, and 72 hours, and at 4 and 7 days after treatment).
Number of animals or in vitro replicates:
6 animals (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After application, the eyes were washed with 40 mL of tap water.
- Time after start of exposure: 4 seconds


SCORING SYSTEM: Ocular lesions were scored using the Draize scale. See below for details.


TOOL USED TO ASSESS SCORE: N/A

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
3
Max. score:
20
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
3
Max. score:
110
Remarks on result:
other: See table below in "Remarks on results including tables and figures" section.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
20
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
110
Remarks on result:
other: See table below in "Remarks on results including tables and figures" section.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
1.7
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.3
Max. score:
20
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
2
Max. score:
110
Remarks on result:
other: See table below in "Remarks on results including tables and figures" section.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
2.5
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Max. score:
20
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
2.8
Max. score:
110
Remarks on result:
other: See table below in "Remarks on results including tables and figures" section.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 4
Score:
4
Max. score:
110
Remarks on result:
other: See table below in "Remarks on results including tables and figures" section.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 7
Score:
2.5
Max. score:
110
Remarks on result:
other: See table below in "Remarks on results including tables and figures" section.
Irritant / corrosive response data:
Corneal opacity involving up to 75% of the cornea was noted in one rabbit from 48 hours post-instillation to Day 7. Iritis was also noted in this rabbit on Day 4 only. Conjunctival redness (vessels definitely injected above normal) was noted in all six rabbits at one hour, cleared in three rabbits by 24 hours, in three rabbits by 48 hours and reoccurred in one rabbit from 48 hours to Day 4. Conjuctival chemosis (any swelling above normal) was noted in three rabbits at one hour only, and in one rabbit on Day 4 only. No conjunctival discharge was noted in any of the six rabbits.
Other effects:
N/A

Any other information on results incl. tables

 

Observation Intervals (Mean scores for all animals)

 

Hours

Days

Observation

1

24

48

72

4

7

Cornea

 

 

 

 

 

 

Mean

0.0

0.0

1.7

2.5

2.5

2.5

S.D.

0.0

0.0

4.1

6.1

6.1

6.1

Range

-

-

0-10

0-15

0-15

0-15

Iris

 

 

 

 

 

 

Mean

0.0

0.0

0.0

0.0

0.8

0.0

S.D.

0.0

0.0

0.0

0.0

2.0

0.0

Range

-

-

-

-

0-5

-

Conjunctivae

 

 

 

 

 

 

Mean

3.0

1.0

0.3

0.3

0.7

0.0

S.D.

1.1

1.1

0.8

0.8

1.6

0.0

Range

2-4

0-2

0-2

0-2

0-4

-

Total Score

 

 

 

 

 

 

Mean

3.0

1.0

2.0

2.8

4.0

2.5

S.D.

1.1

1.1

4.9

6.9

9.8

6.1

Range

2-4

0-2

0-12

0-17

0-24

0-15

 

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was evaluated for eye irritation in rabbits. Based on the results, the test substance is not irritating to rabbit eyes. No CLP or GHS classification is proposed for eye irritation.
Executive summary:

N/A

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