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EC number: 614-503-3 | CAS number: 68441-62-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated
- EC Number:
- 614-503-3
- Cas Number:
- 68441-62-3
- Molecular formula:
- (C3H7O2)xC4H4O2Br2(C4H9O2)y with x + y = 2.5
- IUPAC Name:
- 2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated
- Reference substance name:
- Triethyl phosphate
- EC Number:
- 201-114-5
- EC Name:
- Triethyl phosphate
- Cas Number:
- 78-40-0
- Molecular formula:
- C6H15O4P
- IUPAC Name:
- triethyl phosphate
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): B251, suspensions in 1% tragacanth mucilage.
- Lot/batch No.: Batch No. 1106
- Physical state: liquid
- Analytical purity: not specified
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: TNO, Zeist, The Netherlands
- Age at study initiation: not specified
- Weight at study initiation: 2.5-3.0 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-20
- Humidity (%): 65-85
- Air changes (per hr): not specified
- 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
- Duration of treatment / exposure:
- once without rinsing the eyes thereafter
- Observation period (in vivo):
- reading of reactions of all rabbits were made at 1 hour, at 24, 48 and 72 hours and at 7, 9 and 12 days after treatment.
- Number of animals or in vitro replicates:
- 3 (male rabbits)
- Details on study design:
- At the day of testing both eyes of each rabbit were examined with the aid of a hand slit-lamp. Only those rabbits without eye defects or irritation were
used. A quantity of 0.1 ml of the substance was placed in the left eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup
into which the test substance was placed. The lids were then gently held together for one second and the rabbit was released. The other eye remaining untreated, served as a control. The treated eyes were not rinsed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Regarding the scores of the individual animals, 2/3 animals had a cornea opacity score (mean 24, 48 and 72 hours) >1 (1.7 and 1.3, resp.).
- Irritation parameter:
- other: cornea: area involved
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 12 days
- Remarks on result:
- other: Individual animal mean (24, 48 and 72 hours) scores: 1.3, 1.7 and 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Individual animal mean (24, 48 and 72 hours) scores: 0.7, 1.7 and 0.7
- Irritation parameter:
- other: conjunctivae: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The conjunctivae of all rabbits (individual animal mean (24, 48 and 72 hours) scores: 1.3, 1.7 and 2) and the cornea of two rabbits (two animals with a mean (24, 48 and 72 hours) cornea opacity score >1 (1.7 and 1.3, resp.)) were slightly to moderately irritated the first two days after treatment. After 48 hours the eyes recovered. The effects had disappeared at 7 days after application in one rabbit. In the other two rabbits a slight redness of the conjunctiva was still observed, which had disappeared 12 days after application. The mean (24, 48 and 72 hours) chemosis score was 1 (individual animal mean (24, 48 and 72 hours) scores: 0.7, 1.7 and 0.7) and this effect had disappeared after 72 hours. No iritis was observed.
Any other information on results incl. tables
Numerical grades awarded to the ocular reactions elicited by B 251 |
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Rabbit No. |
Region of the eye |
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Hours (h)/days(d) after application |
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Pre-test |
1h |
24h |
48h |
72h |
7d |
9d |
12d |
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1 |
Cornea |
Opacity |
0 |
1 |
2 |
2 |
1 |
0 |
0 |
0 |
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Area involved |
0 |
4 |
4 |
2 |
1 |
0 |
0 |
0 |
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Iris |
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0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Conjunctiva |
Redness |
0 |
1 |
2 |
2 |
2 |
1 |
1 |
0 |
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Chemosis |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
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Discharge |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
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2 |
Cornea |
Opacity |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
0 |
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Area involved |
0 |
0 |
3 |
2 |
1 |
0 |
0 |
0 |
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Iris |
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0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Conjunctiva |
Redness |
0 |
1 |
2 |
2 |
1 |
0 |
0 |
0 |
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Chemosis |
0 |
0 |
3 |
2 |
0 |
0 |
0 |
0 |
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Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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3 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Area involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Iris |
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0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Conjunctiva |
Redness |
0 |
1 |
2 |
1 |
1 |
1 |
1 |
0 |
||
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Chemosis |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
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Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
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Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Polyol IXOL B251 was irritating to the eyes of rabbits
- Executive summary:
The primary irritation of Polyol IXOL B251 to the rabbit eye was investigated in a study performed according to OECD guideline 405 and under GLP (Duphar B.V., 1985c). To this purpose, 0.1 ml of the test substance was placed into the conjunctival sac of one eye of three male rabbits of the New Zealand White strain. The eyes were examined and the ocular reactions graded at 1 hour, at 24, 48 and 72 hours and at 7, 9 and 12 days after treatment.
The conjunctivae of all rabbits (individual animal mean (24, 48 and 72 hours) scores: 1.3, 1.7 and 2) and the cornea of two rabbits (two animals with a mean (24, 48 and 72 hours) cornea opacity score >1 (1.7 and 1.3, resp.)) were slightly to moderately irritated the first two days after treatment. The effects had disappeared at 7 days after application in one rabbit, while in the other two rabbits a slight redness of the conjunctiva was still observed, which had disappeared 12 days after application. The mean (24, 48 and 72 hours) chemosis score was 1 (individual animal mean (24, 48 and 72 hours) scores: 0.7, 1.7 and 0.7) and this effect had disappeared after 72 hours. No iritis was observed. Based on the mean (24, 48 and 72 hours) cornea opacity scores of 1.7 and 1.3 in two animals, classification for eye irritation is warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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