Registration Dossier
Registration Dossier
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EC number: 268-732-5 | CAS number: 68134-15-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-02-17 to 1992-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
- Molecular formula:
- not available for UVCB
- IUPAC Name:
- Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.21 - 2.37 kg
- Housing: Individually housed in suspended metal cages
- Diet: Ad libitium
- Water: Ad libitium
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -1 21 °C
- Humidity (%): 44 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Pure - Duration of treatment / exposure:
- 72. hours
- Observation period (in vivo):
- 7 days
- Duration of post- treatment incubation (in vitro):
- An additional observation was made in one treated eye on day seven to assess the reversibility of the ocular effects.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 72 hours
SCORING SYSTEM: According to Kay J.H. and Calandra, J.C., Soc. Cosmet. Che., 1962 13, 281-289.
TOOL USED TO ASSESS SCORE: Ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- A dulling of the normal lustre of the corneal surface was noted in one treated eye one hour after treatment with areas of diffuse corneal opacity at the 24, 48 and 72-hour observations. No other adverse corneal effects were noted.
Iridial inflammation was noted in one treated eye one hour after treatment and at the 24 and 48-hour observations. No other adverse iridial effects were noted.
Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation. Moderate conjunctival irritation persisted in one treated eye at the 48-hour observation with minimal conjunctival irritation at the 72-hour observation.
Treated eyes appeared normal 72 hours to 7 days after treatment. - Other effects:
- No other effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an Acute Eye Irritation/Corrosion Test with white rabbits of the New Zealand strain according to OECD Guideline 405, the test item did not produce positive criteria in any test animal. Therefore, the test item is regarded to be not irritating to the eye.
- Executive summary:
The eye irritating effect of the test item was investigated in an Acute Eye Irritation/Corrosion Test according to OECD Guideline 405 and in compliance with GLP principles. Three 12 to 16 weeks old white rabbits of the New Zealand strain (weight at study initiation: 2.21 - 2.37 kg; sex: one male, two females; acclimation period: 5 days) were treated with the undiluted test item by a single application of 0.1 mL to the non-irrigated eye. After consideration of the ocular response produced in the first treated animal, one drop of local anaesthetic (0.5% proxymetacaine hydrochloride) was instilled into both eyes of the other two animals 1 - 2 minutes before treatment in order to minimise pain on instillation of the test material. Assessment of ocular demage / irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Any adverse ocular effects were also noted. Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope.The numerical values corresponding to each animal, tissue and observation time were recorded. An additional observation was made in one treated eye on day seven to assess the reversibility of the ocular effects. In result, a dulling of the normal lustre of the corneal surface was noted in one treated eye one hour after treatment with areas of diffuse corneal opacity at the 24, 48 and 72-hour observations. Iridial inflammation was noted in one treated eye one hour after treatment and at the 24 and 48-hour observations. No other adverse corneal or iridial effects were noted. Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and in two treated eyes at the 24-hour observation. Moderate conjunctival irritation persisted in one treated eye at the 48-hour observation with minimal conjunctival irritation at the 72-hour observation. Treated eyes appeared normal 72 hours to 7 days after treatment. The mean scores for corneal opacity, iridial inflammation, conjunctival redness and conjunctival chemosis were below the value of 2 (max. 1.7). Acording to guideline, the test item did not produce positive effects in any test animal. In conclusion, the test item is regarded to be not corrosive or irritating to the eye. The test is regarded to be valid.
TEST ANIMALS
- Source:
David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.21 - 2.37 kg
- Housing:
Individually housed in suspended metal cages
- Diet: Ad libitium
- Water: Ad libitium
- Acclimation period: 5 days
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: Pure
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