Registration Dossier
Registration Dossier
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EC number: 935-853-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 15 March 2010 and 06 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 15/09/2009 Date of signature: 26/11/2009
Test material
- Reference substance name:
- Reaction mass of 2-(3-ethylphenyl)oxirane and 2,2’-(1,3-phenylene)dioxirane and 2,2'-(1,4-phenylene)dioxirane
- EC Number:
- 935-853-6
- IUPAC Name:
- Reaction mass of 2-(3-ethylphenyl)oxirane and 2,2’-(1,3-phenylene)dioxirane and 2,2'-(1,4-phenylene)dioxirane
- Reference substance name:
- Reaction mass of bis(epoxyethyl) benzene and (ethylphenyl) oxirane
- IUPAC Name:
- Reaction mass of bis(epoxyethyl) benzene and (ethylphenyl) oxirane
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of bis(epoxyethyl) benzene and (ethylphenyl) oxirane
- Substance type: Multiconstituent
- Physical state: clear extremely pale yellow liquid
- Analytical purity: 80 - 95%
- Lot/batch No.: 200901317-17
- Stability under test conditions : Stable
- Storage condition of test material : approximately 4°C in the dark
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:
Harlan Laboratories U.K. Limited, Hillcrest, Belton, Loughborough, UK.
- Age at study initiation:
Twelve to twenty weeks old
- Weight at study initiation:
2.24 to 2.52 kg
- Housing:
The animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet (e.g. ad libitum):
Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
- Water (e.g. ad libitum):
Free access to mains drinking water was allowed throughout the study.
- Acclimation period:
At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
17 to 23°C
- Humidity (%):
30 to 70%
- Air changes (per hr):
At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light):
Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES:
From: day 0 To: day 14
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution):
Undiluted and used as supplied
VEHICLE
Not applicable - Duration of treatment / exposure:
Single application- Observation period (in vivo):
- Animals were observed for up to 14 days.
- Number of animals or in vitro replicates:
- 2 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, a second animal was treated)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not reported
- Time after start of exposure:
Not reported
SCORING SYSTEM:
-(from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
- The Kay & Calandra System
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 68972 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 69053 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects observed
- Irritation parameter:
- iris score
- Basis:
- animal: 68972 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal: 69053 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: redness
- Basis:
- animal: 68972 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: redness
- Basis:
- animal: 69053 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 68972 Male
- Time point:
- other: Mean 24, 48 and 72
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 69053 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Discharge
- Basis:
- animal: 68972 Male
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: Discharge
- Basis:
- animal: 69053 Male
- Time point:
- other: Mean 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Ocular Reactions:
No corneal effects were noted during the study.
Iridial inflammation was noted in both treated eyes at the 24 and 48-Hour observations.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment and at the 24 and 48-Hour observations. Moderate conjunctival irritation persisted in one treated eye with minimal conjunctival irritation noted in the remaining treated eye at the 72 Hour observation. Minimal conjunctival irritation was noted in one treated eye at the 7 Day observation.
One treated eye appeared normal at the 7-Day observation and the remaining treated eye appeared normal at the 14-Day observation. - Other effects:
- Body weight
All animals showed expected gain in bodyweight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC. - Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008
- Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008
Result. A single application of the test material to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 7-Day observation and the remaining treated eye appeared normal at the 14-Day observation.
Conclusion. The test material produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
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