Registration Dossier
Registration Dossier
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EC number: 212-052-3 | CAS number: 756-79-6
Eye irritation
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: scientifically acceptable study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- no
- Remarks:
- well documented study
Test material
- Reference substance name:
- Dimethyl methylphosphonate
- EC Number:
- 212-052-3
- EC Name:
- Dimethyl methylphosphonate
- Cas Number:
- 756-79-6
- Molecular formula:
- C3H9O3P
- IUPAC Name:
- dimethyl methylphosphonate
- Details on test material:
- - Name of test material (as cited in study report): 80 021/B
No additional data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: rabbits (3 males; 3 females) of the Russian breed; no additional data
- Age at study initiation: no data
- Weight at study initiation: 1.6-2.0 kg
- Housing: housed singly in metal cages (overall dimensions 47x32x34 cm)
- Diet (e.g. ad libitum): standard diet of Nafag
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±1°C
- Humidity (%): 55±5%
- Photoperiod (hrs dark / hrs light): 14 hours light/day
Only rabbits showing normal ophthalmic findings were included in the test.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml of the test substance were introduced into the conjunctival sac of the left eye with a syringe
- Concentration (if solution): 100% - Duration of treatment / exposure:
- After application, the eyelids were held open for a few seconds
- Observation period (in vivo):
- up to 8 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes of 3 animals were rinsed 1 minute after application with physiologic saline
SCORING SYSTEM: comparable to the OECD scoring system
The reactions were appraised with a slit lamp after 1 and 6 hours, 1, 2, 3, 6 and 8 days; the results of washed eye animals are not considered hier because they are not comparable to the OECD guideline (evaluation of eye irritation).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- corneal opacity
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hour
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days (one animal still showed a score of 1)
- Remarks on result:
- other: individual mean was 2.0, 1.7 and 1.7 for the 3 animals considered
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hours
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Individual means were 1.0, 0.3 and 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hour
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days (only one animal still present a score of 2)
- Remarks on result:
- other: Individual mean scores were 3.0, 2.0 and 2.9
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of the 3 selected animals (no wash out)
- Time point:
- other: 24-48-72-hour
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days (only one animal still present a score of 1)
- Remarks on result:
- other: Individual mean scores were 2.3, 1.5 and 2.0
- Irritant / corrosive response data:
- based on the irritation scores (see above and Table 1) and on the conjunctival redness in particular, the test substance is irritating to the rabbit eyes
Any other information on results incl. tables
Table 1: Draize scores
time |
Test animal |
Cornea |
Iris |
Conjunctiva |
|||
|
|
Opacity |
Area |
|
Erythema |
Edema |
Secretion |
After 1 hours |
First |
2 |
4 |
1 |
2 |
3 |
2 |
Second |
2 |
4 |
1 |
2 |
2 |
2 |
|
Third |
1 |
4 |
1 |
2 |
3 |
2 |
|
After 24 hours |
First |
2 |
4 |
1 |
3 |
3 |
2 |
Second |
2 |
4 |
1 |
3 |
2 |
2 |
|
Third |
2 |
4 |
1 |
3 |
3 |
2 |
|
After 48 hours |
First |
2 |
4 |
1 |
3 |
2 |
2 |
Second |
2 |
4 |
0 |
2 |
1 |
1 |
|
Third |
2 |
4 |
0 |
3 |
2 |
2 |
|
After 72 hours |
First |
2 |
4 |
1 |
3 |
2 |
2 |
Second |
1 |
4 |
0 |
1 |
0 |
0 |
|
Third |
1 |
4 |
0 |
2 |
1 |
0 |
|
After 8 days |
First |
1 |
4 |
0 |
2 |
1 |
0 |
Second |
0 |
0 |
0 |
0 |
0 |
0 |
|
Third |
0 |
0 |
0 |
0 |
0 |
0 |
|
24-72-72-hour mean (2-animals mean is calculated for those 2 animals showing the worst reactions |
First |
2.0 |
4.0 |
1.0 |
3.0 |
2.3 |
2.0 |
Second |
1.7 |
4.0 |
0.3 |
2.0 |
1.5 |
1.5 |
|
Third |
1.7 |
4.0 |
0.3 |
2.7 |
2.0 |
1.3 |
|
3-animals mean |
1.8 |
4.0 |
0.5 |
2.6 |
1.9 |
1.6 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Results may lead to CAT 2A but reversibility investigation gap, hence worst case CAT 1 assumed.
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