Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Meets national standard methods with acceptable restrictions. Restriction: the eye reactions were scored according to the table contained in the recently retracted OECD TG 405 (dated 1987). This would allow to evaluate whether the substance was irritating. The observation ended 8 days after treatment, but the results of the terminal eye examination was not reported. At the 72-h reading eye reactions were still present.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979
Reference Type:
other company data
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Method: US Federal Register, Title 16, section 1500.42. Similar to OECD TG 405
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl formate
EC Number:
203-481-7
EC Name:
Methyl formate
Cas Number:
107-31-3
Molecular formula:
C₂H₄O₂
IUPAC Name:
methyl formate
Details on test material:
- Name of test material: Methylformiat
- Physical state: liquid
- Analytical purity: 98%
- Impurities: methanol, 2%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: from W . Ostrop / Meerbusch, Germany
- Weight at study initiation: 3.4 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4-6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18°
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no


SCORING SYSTEM:
According to "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p .5 1"
The scoring system is similar to tehtabel contained in OECD TG 405 (adopted 1987), whereas evaluation differs.
TOOL USED TO ASSESS SCORE: ophthalmoscope; fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.78
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: means at 24, 48, 72 hours; all animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.56
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: means at 24, 48, 72 hours; all animals
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.22
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: means at 24, 48, 72 hours; all animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: means at 24, 48, 72 hours; all animals

Any other information on results incl. tables

Eye reactions seen during 24 through 72 hours after treatment (cf. below) were reversible within 8 days.

 

 

Cornea: 

moderate to slight opacity was seen in 2/3 animals after 24 h. Opacity subsided, but was still present (grade1) at 72 h, covering ca. 50%

of the corneal area.

Iris: 

grade 1 iritis was seen in 2/3 animals at 24 and 72 h post treatment.

Conjunctivae: 
Grade 2 reddening was seen in 2/3 animals at 24 and 72 h.


Erythema: 

grade 1 in all animals at 24 h, grade 2 and 1 at 72 h in 2/3 animals.


Discharge: 

grade 2 and 3 in 2/3 animals at 24 h, grade 1 and 2 in 2/3 animals at 72 h.

 

 

Effect

Time

(hours)

Animal No.

1

2

3

Cornea

opacity

24

2

1

0

 

 

48

1

1

0

 

 

72

1

1

0

Iris

 

24

1

1

0

 

 

48

0

1

0

 

 

72

1

1

0

Conjunctivae

redness

24

2

2

0

 

 

48

2

2

0

 

 

72

2

1

0

Means

(24-72 h)

2

1.67

0

 

chemosis

24

1

1

1

 

 

48

4

1

0

72

2

1

0

 

 

Means

(24-72 h)

2.33

1

0.33

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Executive summary:

Conclusion:

Undiluted methylformate was examined in three white rabbits according to a method described in the Federal Register (FR, Title 16, section 1500.42). Moderate to slight corneal opacity was seen in 2 of 3 animals after 24 hours. Opacity subsided, but was still present (grade 1) at 72 hours, covering approximately 50 % of the corneal area. Grade 1 iritis was also seen in 2 of 3 animals at 24 and 72 hours post treatment. The conjunctivae showed grade 2 reddening in 2/3 animals at 24 and 72 hours, grade 1 erythema in all animals at 24 hours, grade 2 and 1 at 72 hours in 2/3 animals, and grade 2 and 3 discharge in 2/3 animals at 24 hours, grade 1 and 2 in 2/3 animals at 72 hours. Thus the substance was irritating to the eyes (BASF AG, 1979; Fraunhofer-Gesellschaft 1979).

Categories Display