Registration Dossier
Registration Dossier
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EC number: 918-668-5 | CAS number: 128601-23-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990/05/02-1990/05/15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 405. GLP
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:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hydrocarbons, C9, aromatics
- EC Number:
- 918-668-5
- Cas Number:
- 128601-23-0
- Molecular formula:
- C9H12
- IUPAC Name:
- Hydrocarbons, C9, aromatics
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Sex: female (6)
- Age at study initiation: 14 weeks
- Weight at study initiation: 2.48-2.75 kg
- Housing: Individually
- Diet (e.g. ad libitum): Agway Certified Diet R.C.A. Rabbit (pellets), restricted with new food each day
- Water (e.g. ad libitum): Automatic watering system, ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-70
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): neat - 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, 4, 24, 48, and 72 hrs post instillation and once per day on days 4 and 7.
- Number of animals or in vitro replicates:
- Female (6)
- Details on study design:
- SCORING SYSTEM: Draize scale for ocular irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 1.33
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1-72 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1-72 hrs
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Mean 24, 48, and 72-hour scores not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Mean 24, 48, and 72-hour scores not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Mean 24, 48, and 72-hour scores not specified
- Irritant / corrosive response data:
- Redness was noted for all animals at the 1 hr observation point, for 3 animals at the 24 hr observation point, and for two animals at the 48 hr observation point. Chemosis was noted for all animals at the 1 hr observation and for 1 animal at the 24 hr observation point. Only one animal was noted in having discharge at the 1 hr time point. All animals were free of any occular irritation after the 48 hr observation. The maximum Draize score was 8 at the 1 hr time point.
Any other information on results incl. tables
Summary of other eye irritation studies:
| Chemical Name: | Hydrocarbons, C9, aromatics | ||||||||||||||||||||||||
| Reference Substance: | |||||||||||||||||||||||||
| CAS Number: | 64742-95-6 | ||||||||||||||||||||||||
| EC Number: | 265-199-0 | ||||||||||||||||||||||||
| SMILES: | |||||||||||||||||||||||||
| End Point | Study Reference | ||||||||||||||||||||||||
| REACH requirement | IUCLID Section | Study Name | Data Waiving | Waiving Justification | Species | Study Result Type | Test Guideline/Qualifier | Test Guideline/Guideline | Test Guideline/Deviations | Reliability | Rational For Reliability | GLP Compliance | Test Materials/Identity | Study Result | Reference Type | Reference Author | Reference Year | Reference Title | Bibliographic Source | Testing Laboratory | Reference Report No. | Owner Company | Company Study No. | Report Date | Data access |
| 8.2 Eye Irritation | 7.3.2 | Draize Eye Irritation Studies - Rabbits | Rabbit | Experimental result | Equivalent or similar to | OECD guideline 405 | Eyes of some animals were irrigated | 2 | Acceptable, well-documented study report in general agreement with OECD guideline 405. Not performed according to GLP. | No | MRD-61-14 | not irritating | Study report | ANON | 1961 | Draize Eye Irritation Studies - Rabbits | HSPA0147 | Hazleton Laboratories | ExxonMobil Petroleum & Chemical BVBA | 61MRL7 | yes | ||||
| 8.2 Eye Irritation | 7.3.2 | Ocular Irritation Study in the Rabbit | Rabbit | Experimental result | Equivalent or similar to | OECD guideline 405 | Failed to continue study to 21 days when symptoms were still present at 72 hrs. | 2 | Similar to OECD guideline 405. | yes | MRD-90-720 | not classifiable | Study report | ANON | 1990 | Ocular Irritation Study in the Rabbit | HSPA0150 | Exxon Biomedical Sciences, Inc. | 172013 | ExxonMobil Petroleum & Chemical BVBA | 90MRL166 | 12/06/1990 | yes | ||
| 8.2 Eye Irritation | 7.3.2 | Eye Irritation Study in Rabbits | Rabbit | Experimental result | Equivalent or similar to | OECD guideline 405 | No | 2 | Similar to OECD guideline 405. | No data | MRD-ECH-80-14 | not irritating | Study report | ANON | 1980 | Eye Irritation Study in Rabbits | HSPA0148 | Bio/dynamics Inc. | 29641 | ExxonMobil Petroleum & Chemical BVBA | 80MRL16 | 11/07/1980 | yes | ||
| 8.2 Eye Irritation | 7.3.2 | Eye Irritation | Rabbit | Experimental result | According to | Federal Register, 28, (110), 6.6.1963. para 191.12. Test for eye irritation. | No | 2 | Summary only of study. | No data | Shellsol A | not irritating | Study report | Coombs, AD, Blair, D, Doak, SM, Carter, BI | 1977 | The Acute Toxicity of Shellsol A | HSPA0686 | Sittingbourne Research Centre | M(T)-1-77 | Shell Chemicals Europe BV | June, 1977 | yes | |||
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the individual and mean scores of ocular irritations, test substance would not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
- Executive summary:
This study was conducted to determine the potential of the substance to cause irritation to the eye in a rabbit model system. Six rabbits were instilled with 0.1 ml of MRD-89 -522, neat. Ocular examinations occurred at 1, 4, 24, 48, and 72 hrs, and days 4 and 7 post instillation. Ocular damage was assessed and scored according to the Draize eye test. All animals survived the exposure. Maximum observed Draize score was 8. Irritation subsided as the study progressed and all animals were clear of ocular irritation after the 48 hr observation. Based on the individual and mean scores, test substance should not be considered an ocular irritant under either EU GHS guidelines or under the EU requirements for dangerous substances and preparations guidelines.
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