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EC number: 217-285-4 | CAS number: 1798-60-3
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: Acceptable Draize Test, GLP was not compulsory at the time the study was conducted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Principles of method if other than guideline:
- Draiz Test, according to Fed. Reg. 38, No. 187, Para. 1500.42, S. 27019, 1973-09-27
- GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was conducted
Test material
- Reference substance name:
- (R)-1-hydroxy-1-phenylacetone
- EC Number:
- 217-285-4
- EC Name:
- (R)-1-hydroxy-1-phenylacetone
- Cas Number:
- 1798-60-3
- Molecular formula:
- C9H10O2
- IUPAC Name:
- (1R)-1-hydroxy-1-phenylpropan-2-one
- Details on test material:
- - Name of test material: (-)-Phenylacetylcarbinol
- Physical state: liquid
- Analytical purity: 67.4 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler, 6050 Offenbach/ Main
- Weight at study initiation: 2.95 kg (mean, males), 2.92 (mean, females)
- Housing: single housing in steel cages, cage area: 40 x 51 cm
- Diet: Ovator Solikanin (Muskator-Werke, 4000 Düsseldorf), 130 g /day/animal
- Water: 250 mL/ day/ animal
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 26
- Humidity (%): 50- 80
- Photoperiod (hrs dark / hrs light): 12/ 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 4 males, 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM:
- Reading time points: 1, 24, 48, 72 hrs, 8 days
- Scoring of eye reaction: according to Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal: 1, 2, 3 and 4, respectively
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: in this animals, corneal opacity was graded 2 at test ending.
- Irritation parameter:
- cornea opacity score
- Remarks:
- (mean)
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal: 1 and 5, respectively
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- other: the finding was fully reversible within 8 days in animal 1; in animal 5, the effect still was present at day 8
- Irritation parameter:
- iris score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal: 2 and 4, respectively
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: no effects in the iris of these 2 animals were seen.
- Irritation parameter:
- iris score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal: 3 and 6, respectively
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 hours
- Remarks on result:
- other: Effect in the iris only were seen at 24 hrs.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal: 1, 2, 3, 4, 5 and 6, respectively
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal: 1 and 5, respectively
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- other: The finding was fully reversible in animal 1 at day 8 whereas it was still visible in animal 5.
- Irritation parameter:
- chemosis score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Remarks:
- (mean of the 3 time points given below)
- Basis:
- animal: 4 and 6, respectively
- Time point:
- other: 24, 48, 72 hrs
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs in animal 4 and 48 h in animal 6
- Irritant / corrosive response data:
- Corneal opacity, iritis, conjunctival redness and chemosis were seen in all treated animals, and almost all findings remained until day 8. Eye secretion graded 1 to 2 also was reported for all animals until time point 72 hours; in one case, i.e. animal 5, secretion still was noticed at day 8.
- Other effects:
- Myosis was reported for animal 5 and 6 at time point 24 hrs only. Scar formation on the eyelid of 3 animals was seen after 48 hrs and on further 2 animals after 72 hrs; the finding was not reversible within 8 days.
Any other information on results incl. tables
Table 1: Results of eye irritation scores (animals 1 -3)
Observation time |
Rabbit No. |
Rabbit No. |
Rabbit No. |
|||||||||||||
1 |
2 |
3 |
||||||||||||||
cornea |
area of cornea involved |
iris |
conjunctiva |
chemosis |
cornea |
area of cornea involved |
iris |
conjunctiva |
chemosis |
cornea |
area of cornea involved |
iris |
conjunctiva |
chemosis |
||
1h |
0 |
0 |
0 |
2 |
3 |
0 |
0 |
0 |
2 |
3 |
0 |
0 |
0 |
2 |
3 |
|
24 h |
1 |
4 |
1 |
2 |
2 |
1 |
4 |
0 |
2 |
2 |
1 |
4 |
1 |
2 |
2 |
|
48 h |
1 |
4 |
1 |
2 |
2 |
1 |
4 |
0 |
2 |
1 |
1 |
4 |
0 |
2 |
1 |
|
72 h |
1 |
4 |
1 |
2 |
1 |
1 |
4 |
0 |
2 |
1 |
1 |
4 |
0 |
2 |
0 |
|
8 d |
1 |
4 |
0 |
1 |
0 |
1 |
3 |
0 |
1 |
0 |
1 |
4 |
0 |
1 |
0 |
|
Mean value 24 + 48 + 72 h |
1.00 |
|
1.00 |
2.00 |
1.67 |
1.00 |
|
0.00 |
2.00 |
1.33 |
1.00 |
|
0.33 |
2.00 |
1.00 |
|
Mean value 24 + 48 + 72 h all animals |
1.00 |
|
0.44 |
2.00 |
1.33 |
|
|
|
|
|
|
|
|
|
|
|
mean score 4 out of 6 |
1 |
|
0.33 |
2.00 |
1 |
|
|
|
|
|
|
|
|
|
|
|
Table 2: Results of eye irritation scores (animals 4 -6)
Observation time |
Rabbit No. |
Rabbit No. |
Rabbit No. |
|||||||||||||
4 |
5 |
6 |
||||||||||||||
cornea |
area of cornea involved |
iris |
conjunctiva |
chemosis |
cornea |
area of cornea involved |
iris |
conjunctiva |
chemosis |
cornea |
area of cornea involved |
iris |
conjunctiva |
chemosis |
||
1h |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
2 |
3 |
0 |
0 |
0 |
2 |
2 |
|
24 h |
1 |
4 |
0 |
2 |
1 |
1 |
4 |
1 |
2 |
2 |
1 |
4 |
1 |
2 |
2 |
|
48 h |
1 |
4 |
0 |
2 |
1 |
1 |
4 |
1 |
2 |
2 |
1 |
4 |
0 |
2 |
0 |
|
72 h |
1 |
4 |
0 |
2 |
0 |
1 |
4 |
1 |
2 |
1 |
1 |
4 |
0 |
2 |
0 |
|
8 d |
1 |
3 |
0 |
1 |
0 |
1 |
4 |
1 |
2 |
0 |
0 |
0 |
0 |
1 |
0 |
|
Mean value 24 + 48 + 72 h |
1.00 |
|
0.00 |
2.00 |
0.67 |
1.00 |
|
1.00 |
2.00 |
1.67 |
1.00 |
|
0.33 |
2.00 |
0.67 |
|
Mean value 24 + 48 + 72 h all animals |
1.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
mean score 4 out of 6 |
1 |
|
0.33 |
2.00 |
1 |
|
|
|
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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