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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not mentioned.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
information on animal husbandry and environmental conditions was not provided.
GLP compliance:
no
Remarks:
Study conducted prior to GLP guidelines

Test material

Constituent 1
Chemical structure
Reference substance name:
Tricarbonyl(methylcyclopentadienyl)manganese
EC Number:
235-166-5
EC Name:
Tricarbonyl(methylcyclopentadienyl)manganese
Cas Number:
12108-13-3
Molecular formula:
C9H7MnO3
IUPAC Name:
tricarbonyl(methyl-η5-cyclopentadienyl)manganese
Details on test material:
- Name of test material: MMT Tecnhical
- Physical state: Amber liquid
- Analytical purity: Not mentioned
- Purity test date: No mentioned
- Lot/batch No.: 548-76

Please refer to section 13 "Purity statement".

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Not mentioned
- Age at study initiation: Not mentioned
- Weight at study initiation: 1.9-2.3 kg
- Housing: Individually housed
- Diet : Not mentioned
- Water : Not mentioned
- Acclimation period: Not mentioned

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration : 100%


Duration of treatment / exposure:
The test substance was administrated to the eye of the rabbit, and not further removed.
Observation period (in vivo):
Animals were observed for 7 days post-exposure as symptoms persisted at maximum of 4 days post-dosage.
Number of animals or in vitro replicates:
Six rabbits.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No
- Time after start of exposure: N.A.

SCORING SYSTEM: Check below "Any other information on materials and methods incl. tables".


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See Table 1 and Table 2

Any other information on results incl. tables

Table 1 - Individual score for eye irritation

Animals No.

Time after administration - Days

Positive

score

1

2

3

4

7

791

1. Cornea

A. Opacity

0

0

0

0

0

No

B. Stippling

0

0

0

0

0

No

D. Ulceration

0

0

0

0

0

No

Score

0

0

0

0

0

No

2. Iris

0

0

0

0

0

No

Score

0

0

0

0

0

 

3. Conjunctivae

A. Redness

1

0

0

0

0

No

B. Chemosis

1

0

0

0

0

No

C. Discharge

0

0

0

0

0

 

D. Necrosis

Or Ulceration

0

0

0

0

0

No

Score

4

0

0

0

0

 

Total score

4

0

0

0

0

 

792

1. Cornea

A. Opacity

0

0

0

0

0

No

B. Stippling

0

0

0

0

0

 

D. Ulceration

0

0

0

0

0

No

Score

0

0

0

0

0

 

2. Iris

0

0

0

0

0

No

Score

0

0

0

0

0

 

3. Conjunctivae

A. Redness

1

1

0

0

0

No

B. Chemosis

0

0

0

0

0

No

C. Discharge

0

0

0

0

0

 

D. Necrosis

Or Ulceration

0

0

0

0

0

No

Score

2

2

0

0

0

 

Total score

2

2

0

0

0

 

793

1. Cornea

A. Opacity

0

0

0

0

0

No

B. Stippling

0

0

0

0

0

 

D. Ulceration

0

0

0

0

0

No

Score

0

0

0

0

0

 

2. Iris

0

0

0

0

0

No

Score

0

0

0

0

0

 

3. Conjunctivae

A. Redness

1

0

0

0

0

No

B. Chemosis

1

0

0

0

0

No

C. Discharge

0

0

0

0

0

 

D. Necrosis

Or Ulceration

0

0

0

0

0

No

Score

4

0

0

0

0

 

Total score

4

0

0

0

0

 

794

1. Cornea

A. Opacity

0

0

0

0

0

No

B. Stippling

0

0

0

0

0

 

D. Ulceration

0

0

0

0

0

No

Score

0

0

0

0

0

 

2. Iris

0

0

0

0

0

No

Score

0

0

0

0

0

 

3. Conjunctivae

A. Redness

0

0

0

0

0

No

B. Chemosis

0

0

0

0

0

No

C. Discharge

0

0

0

0

0

 

D. Necrosis

Or Ulceration

0

0

0

0

0

No

Score

0

0

0

0

0

 

Total score

0

0

0

0

0

 

796

1. Cornea

A. Opacity

0

 

 

 

 

 

B. Stippling

0

 

 

 

 

 

D. Ulceration

0

 

 

 

 

 

Score

0

 

 

 

 

 

2. Iris

0

 

 

 

 

 

Score

0

 

 

 

 

 

3. Conjunctivae

A. Redness

1

1

1

0

0

No

B. Chemosis

0

0

0

0

0

No

C. Discharge

0

0

0

0

0

 

D. Necrosis

Or Ulceration

0

0

0

0

0

No

Score

2

2

2

0

0

 

 

2

2

2

0

0

 

798

1. Cornea

A. Opacity

0

0

0

0

0

No

B. Stippling

0

0

0

0

0

 

D. Ulceration

0

0

0

0

0

No

Score

0

0

0

0

0

 

2. Iris

0

0

0

0

0

No

Score

0

0

0

0

0

 

3. Conjunctivae0

A. Redness

1

1

0

0

0

No

B. Chemosis

0

0

0

0

0

No

C. Discharge

0

1

0

0

0

 

D. Necrosis

Or Ulceration

0

0

0

0

0

No

Score

2

4

0

0

0

 

Total score

2

4

0

0

 

 

Table 2 - Summary of response and Maximum Draize Scores

Positive (+) or Negative (-) Scores

 

Conjunctivae

 

Animal

Number

Cornea

Iris

Redness

Chemosis

Necrosis or

Ulceration

Clear at

Day

Maximum

Draize score

791

-

-

-

-

-

2

2

792

-

-

-

-

-

3

2

793

-

-

-

-

-

2

4

794

-

-

-

-

-

1

0

796

-

-

-

-

-

4

2

798

-

-

-

-

-

3

4

Total

0

0

0

0

0

 

14

 

Mean: 2

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
mmt did not produce a response indicative ocular irritation upon direct contact with the eye.
Executive summary:

In this eye irritation study, 0.1 ml of mmt- technical was instilled into the conjunctival sac of six albino New Zealand rabbits. No effects were observed 7 dayts post exposure , so the study was terminated. Irritation was scored by the method of Draize. The main observed effect was a mild conjunctivae, some vessels injected (score 1), in 5 of the 6 animals exposed, and a mild chemosis in one animal (score 1). The few irritations observed lasted at maximum 4 days in the animals. mmt would not be classified as an eye irritant per EC/1272/2008.