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EC number: 926-273-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From April 23, 1990 to May 24, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report in agreement with OECD guideline 405-GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From April 23, 1990 to May 24, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report in agreement with OECD guideline 405-GLP
- Justification for type of information:
- The justification for read across is provided as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.46
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 1.17
- Max. score:
- 2
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.5
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.17
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 1.67
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Other effects:
- Alopecia around the treated eye was noted for one animal on days 10 and 14.
One animal died prior to study termination (day 3). This animal exhibited poor food consumption, distended abdomen, and small amount of stool on day 2. It was the opinion of the study director that this death was not test material related, but due to a gastro-intestinal problem. - Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C10 aromatics, >1% naphthalene based on analogue read across.
Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.50, 0.17, and 0.60 respectively. The scores for chemosis were 1.67, 0, and 0. There were no positive scores for corneal, or iridial irritation. Ocular irritation was most prominent at the 1 hour, 72 hour and day 4 observations where the total Draize score ranged from 4-12. Additional observations included alopecia in one animal on days 10 and 14. All other animals were free of signs of irritation within 14 days of dosing. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- increased number of animals
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbons, C10, aromatics, >1% naphthalene
- EC Number:
- 919-284-0
- Molecular formula:
- None available - not a single isomer - see remarks
- IUPAC Name:
- Hydrocarbons, C10, aromatics, >1% naphthalene
- Details on test material:
- - Name of test material (as cited in study report): MRD-89-523
- Physical state: colorless liquid
- Lot/batch No.: Batch I
- Analytical purity: assume purity 100%
- Stability under test conditions: Not documented. Material stable under normal conditions
- Storage condition of test material: Room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research
- Age at study initiation: Approximately 14 weeks
- Weight at study initiation: 2.29-2.75 kg
- Housing: Individual
- Diet (e.g. ad libitum): restricted feeding regimen per manufacturers recommendation
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained range of 18.3-21.1 °C
- Humidity (%): maintained range of 40-60%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1990-05-08 To: 1990-05-22
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- Test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to prevent loss of material
- Observation period (in vivo):
- 1, 24, 48, 72 hours post-instillation and once per day on days 4, 7, 10, and 14
- Number of animals or in vitro replicates:
- Six animals (all females)
- Details on study design:
- SCORING SYSTEM: Draize Method
TOOL USED TO ASSESS SCORE: 2% sodium fluorescein dye under UV light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.46
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 1.17
- Max. score:
- 2
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.5
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0.17
- Max. score:
- 1
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 1.67
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Other effects:
- Alopecia around the treated eye was noted for one animal on days 10 and 14.
One animal died prior to study termination (day 3). This animal exhibited poor food consumption, distended abdomen, and small amount of stool on day 2. It was the opinion of the study director that this death was not test material related, but due to a gastro-intestinal problem.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
- Executive summary:
Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge. Mean scores for redness at 24, 48, 72 hours were 0.50, 0.17, and 0.60 respectively. The scores for chemosis were 1.67, 0, and 0. There were no positive scores for corneal, or iridial irritation. Ocular irritation was most prominent at the 1 hour, 72 hour and day 4 observations where the total Draize score ranged from 4-12. Additional observations included alopecia in one animal on days 10 and 14. All other animals were free of signs of irritation within 14 days of dosing. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
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