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EC number: 207-074-5 | CAS number: 431-47-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from NTRL reports
Data source
Reference
- Reference Type:
- secondary source
- Title:
- INITIAL SUBMISSION: LOCAL TOLERANCE TEST IN RABBITS-CUTANEOUS PRIMARY IRRITATION –OCCULAR IRRITATION OF METHYL TRIFLUROACETATE IN RABBITS WITH COVER LITTER DATED 101692
- Author:
- NTRL reports
- Year:
- 1 992
- Bibliographic source:
- OTS0571344, NTRL report, last updated 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the ocular irritation potential of methyl trifluoroacetate according to OECD 405 Guidelines
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methyl trifluoroacetate
- EC Number:
- 207-074-5
- EC Name:
- Methyl trifluoroacetate
- Cas Number:
- 431-47-0
- Molecular formula:
- C3H3F3O2
- IUPAC Name:
- methyl 2,2,2-trifluoroacetate
- Test material form:
- liquid
- Details on test material:
- - Name of the test chemical: methyl trifluoroacetate
- Molecular formula: C3H3F3O2
- Molecular weight: 128.05 g/mol
- Smiles notation: O=C(OC)C(F)(F)F
- InChl: 1S/C3H3F3O2/c1-8-2(7)3(4,5)6/h1H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of the test chemical: methyl trifluoroacetate
- Molecular formula: C3H3F3O2
- Molecular weight: 128.05 g/mol
- Smiles notation: O=C(OC)C(F)(F)F
- InChl: 1S/C3H3F3O2/c1-8-2(7)3(4,5)6/h1H3
- Substance type: Organic
- Physical state: Liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Details on test animals
- sex: Male
- Source: Charles river
- Age at study initiation: No data
- Weight at study initiation: 2.5 kg (200g)
- Fasting period before study:
- Housing: The rabbits were kept in individual polystyrene cages, measuring 540×360×315mm with a perforated polystyrene flour in ventilated and air conditioner room.
- Diet: 150gm of complete maintenance food (granules Lapin Entration “112” UAR, 91360 – Villemoisson/Drge) is provided per rabbit per day.
- Water: ad libitum (softened and filtered water- 15 µ)
- Acclimation period: 8 days
Or Test Tissue
- Source: Not applicable
- Type: Not applicable
- Acclimation: Not applicable
- Housing conditions: Not applicable
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3
- Humidity (%):30 to 70 %
- Air changes (per hr): 12 to 14 times per hours (pre-filtered air: 5- 10 µ)
- Photoperiod (hrs dark / hrs light): artificial lighting for 12 hrs (7.30am to 7.30pm)
IN-LIFE DATES: From: To: No data available
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye of six rabbits serves as control
- Amount / concentration applied:
- 0.1ml
- Duration of treatment / exposure:
- The upper and lower eyelids are held together for 10 seconds to avoid any loss of test substance.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours post instillation. The observation period can be extended to 7 and 14 days to study the corrosive potential of test substance
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: conjunctival sac
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Ocular examinations are carried out for each rabbit and rated according to the following scale
Conjunctival lesions:
Chemosis (lids and/or nictating membranes)
No swelling =1
Any swelling above normal (including nictating membrane) = 1
Obvious swelling with partial eversion of lids = 2*
Swelling with lids about half closed = 3*
Swelling with lids more than half closed = 4*
Redness:
Blood vessels normal = 0
Some blood vessels definitely hyperemic = 1
Diffuse, crimson color, individual vessels not easily discernible = 2*
Diffuse beefy red = 3*
Iris:
Normal = 0
Markedly deepened rugae, congestion, swelling moderate circumcorneal hyperaemia, or injection [any of these or combination of any thereof], iris still positively reacting to light = 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) = 2*
Corneal lesions
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity = 0
Scaterred or diffuse areas of opacity(other than slight dulling of normal luster) details of iris clearly visible = 1*
Easily discernible transcluent area, details of iris slightly obscured = 2*
Nacreous area, no details of iris visible, size of pupil barely discernible = 3*
Opaque cornea, iris not discernible through the opacity = 4*
Area of cornea affected
One quarter (or less) but not zero = 1
Greater than one quarter, but less than half = 2
Greater than one half, but less than three quarters = 3
Greater than three quarters, up to whole area = 4
*-figures indicate positive effect
A qualitative evaluation of any ulceration of cornea was conducted to determine the irritative capacity of test substance
Ulceration (loss of substance with or without swelling of the eyes)
No ulceration = 0
Presence of ulceration = U
The mean values are respectively calculated for each lesion evaluated on the 6 rabbits examined for conjunctivae, iris and the cornea at 24,48 and 72 hours after instillation of the test chemical.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.55
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- edema
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.45
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.61
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours.
Any other information on results incl. tables
Table for scoring of ocular lesions:
Readings |
Rabbits |
Conjunctivae |
Iris |
Cornea |
||||
Chemosis |
Edema |
Reflex |
Congestion |
Degree of opacity |
Surface area |
Ulceration |
||
1 hour
|
1275 |
1 |
1 |
N |
1p |
2 |
1 |
U |
1276 |
2 |
2 |
N |
1p |
2 |
1 |
U |
|
1277 |
2 |
2 |
N |
1p |
2 |
2 |
U |
|
1278 |
1 |
2 |
N |
1p |
2 |
1 |
U |
|
1279 |
2 |
1 |
N |
1p |
2 |
1 |
U |
|
1280 |
2+ |
2 |
N |
1p |
2 |
2 |
U |
|
24 hours |
1275 |
1 |
0 |
N |
0 |
0 |
0 |
0 |
1276 |
2 |
2 |
N |
1p |
2 |
2 |
U |
|
1277 |
2 |
2 |
N |
1p |
2 |
2 |
U |
|
1278 |
1 |
2 |
N |
1p |
2 |
1 |
U |
|
1279 |
2 |
2 |
N |
1p |
2 |
1 |
U |
|
1280 |
2+ |
2 |
N |
1p |
2 |
2 |
U |
|
Mean |
1.83 |
1.67 |
|
0.83 |
1.67 |
|
|
|
48 hours |
1275 |
1 |
0 |
N |
0 |
0 |
0 |
0 |
1276 |
2 |
2 |
N |
1p |
2 |
2 |
U |
|
1277 |
1 |
2 |
N |
1p |
2 |
1 |
U |
|
1278 |
1 |
2 |
N |
1p |
2 |
1 |
U |
|
1279 |
1 |
1 |
N |
1p |
2 |
1 |
U |
|
|
1280 |
2 |
2 |
N |
1p |
2 |
2 |
U |
Mean |
1.50 |
1.50 |
|
0.83 |
1.83 |
|
|
|
72 hours |
1275 |
0 |
0 |
N |
0 |
0 |
0 |
0 |
1276 |
1 |
1 |
N |
1p |
2 |
1 |
U |
|
1277 |
2 |
2 |
N |
1p |
2 |
3 |
U |
|
1278 |
2 |
2 |
N |
1c |
0 |
0 |
0 |
|
1279 |
1 |
0 |
N |
1p |
2 |
1 |
U |
|
1280 |
2 |
2 |
N |
1p |
2 |
2 |
U |
|
Mean |
1.33 |
1.17 |
|
0.83 |
1.83 |
|
|
|
Mean 24+48+72 |
|
1.55 |
1.45 |
|
0.83 |
1.61 |
|
|
Observations
+ -Edema of the palpebral conjunctiva and nictitating membrane
+/- -Permanent myosis with conservation of reflex direct photometer
p- Circumcorneal injections + iris congestion
c- circumcorneal injections
Table of average values, for each type of lesion, calculated with 6 rabbits for readings at 24, 48 and 72 hours
|
Readings |
Mean 24+48+72 hours |
||
24 hours |
48 hours |
72 hours |
||
Conjunctivae |
|
|
|
|
Chemosis |
1.83 |
1.50 |
1.33 |
1.55 |
Edema |
1.67 |
1.50 |
1.17 |
1.45 |
Iris Congestion |
0.83 |
0.83 |
0.83 |
0.83 |
Cornea Opacity |
1.67 |
1.83 |
1.33 |
1.61 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours. The mean values of Chemosis, edema, iris and corneal opacity were 1.55, 1.45, 0.83 and 1.61 respectively.
Methyl trifluoroacetate (TFAM) was considered according to Annex VI of Directive 83/467 published in the Official Journal of the European Communities as Not Irritant. - Executive summary:
The ocular irritation potential of methyl trifluoroacetate was assessed in rabbits. The study was performed according to OECD 405 Guidelines. 0.1 ml of the test substance was deposited in the conjunctival sac of 6 male albinoNew Zealand rabbits with a hundredth graduated sterile polypropylene syringe (Becton Dickinson) of 1ml. Each rabbit was immobilized in a plastic restraining box. The test chemical is introduced into the inferior conjunctival sac of the right eye, left serves as control. The eyelids are held together for 10 seconds to avoid material loss. The animals are restrained for one hour and then replaced in cages. The eyes remained unrinsed throughout the test. The eyes were evaluated for ocular lesions at 1, 24, 48 and 72 hours post instillation. The observation period can be extended to 7 and 14 days to study the corrosive potential of test substance. The mean values are respectively calculated for each lesion evaluated on the 6 rabbits examined for conjunctivae, iris and the cornea at 24, 48 and 72 hours after instillation of the test chemical.
When methyl trifluoroacetate was instilled in the eyes of 6 rabbits, permanent myosis, congestion of the iris and edema of the ocular membranes were noted. Corneal ulceration was observed in 4 of 6 animals at 72 hours.
The mean values of Chemosis, edema, iris and corneal opacity were1.55, 1.45, 0.83 and 1.61 respectively.
Methyl trifluoroacetate (TFAM) was considered according to Annex VI of Directive 83/467 published in the Official Journal of the European Communities as Not Irritant.
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