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EC number: 220-482-8 | CAS number: 2781-11-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jul - 16 Dec 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- 1978
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
- EC Number:
- 220-482-8
- EC Name:
- Diethyl bis(2-hydroxyethyl)aminomethylphosphonate
- Cas Number:
- 2781-11-5
- Molecular formula:
- C9H22NO5P
- IUPAC Name:
- diethyl {[bis(2-hydroxyethyl)amino]methyl}phosphonate
- Test material form:
- liquid: viscous
- Details on test material:
- - Physical state: viscous liquid
- Colour: amber
- Expiry date: not reported
Constituent 1
- Specific details on test material used for the study:
- - Receipt date: 25 Jun 1981
- Color: amber
- Form: viscous liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Stauffland albino rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, USA
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 µL
- Duration of treatment / exposure:
- 3 animals: 20-30 sec
6 animals: 7 d - Observation period (in vivo):
- 7 days with several reading time points (1, 2, 3, 4, and 7 d after treatment)
- Number of animals or in vitro replicates:
- 9 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 20-30 sec
SCORING SYSTEM: Draize guidelines (1965)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6 (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6 (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6 (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Redness of the conjunctiva which occured only in the test animals with unwashed eyes was observed at day one and two. This effect was fully reversible within 3 days in all animals and the average score (24/48/72 h) for the conjunctiva was not greater than or equal to 2.
- Other effects:
- - Effects of rinsing or washing: When rinsing the eye with water 20-30 sec after treatment, no irritation was observed.
Any other information on results incl. tables
Table 1: Individual Draize scores and means (total scores) for 24 h, 48 h and 72 h
Animal number |
Irritation |
Pre-treatment |
Individual scores after |
Weighted total scores (mean) after |
|||||
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
||||
81-F-206 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
1 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-207 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
2 |
0 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-214 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
6 |
4 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
2 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
1 |
1 |
0 |
|||||
81-F-215 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
4 |
2 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
2 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-216 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
1 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-217 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
1 |
0 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a primary eye irritation study conducted similarly to OECD TG 405, 0.1 mL of undiluted test material was instilled into the conjunctival sac of one eyes of 9 female Stauffland albino Rabbits. On 3 of these animals the eye was washed with water 20-30 seconds after exposure, and on the remaining 6 animals the eyes were not washed. Irritation was scored according to the Draize scale.
Mean (24/48/72 hrs, unwashed eye) individual corneal opacity / iris / chemosis score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Mean (24/48/72 hrs, unwashed eye) individual conjunctiva score: 0.67 / 0.67 / 1.00 / 1.00 / 0.67 / 0.67.
Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
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