Registration Dossier
Registration Dossier
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EC number: 286-081-5 | CAS number: 85186-95-4
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 15. Nov. 2010 - 20. Jan. 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the government of the United Kingdom
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
- EC Number:
- 286-072-6
- EC Name:
- Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
- Cas Number:
- 85186-86-3
- IUPAC Name:
- 85186-86-3
- Details on test material:
- - Physical state: yellow liquid
- Analytical purity: 91 %
- Lot/batch No.: OE10817
- Expiration date of the lot/batch: 21. Oct. 2016
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand white (Hsdlf:NZW)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.47 to 2.83 kg
- Housing: individually in suspended cages
- Diet: 2930 Teklad Global Certified Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 hours
reading time points at 1, 24, 48 and 72 hours - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over animal #1 and #3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- No corneal or iridal effects were noted during the study.
Moderate conjunctival irritation was noted in one treated eye and minimal conjunctival irritation was noted in two treated eyes one hour after treatment. Minimal conjunctival irritation was noted in two eyes at the 24 h observation and persisted in one treated eye at the 48 h observation.
One treated eye appeared normal at the 24 h observation, another treated eye appeared normal at the 48 h observation and the remaining treated eye appeared normal at the 72 h observation. - Other effects:
- No bodyweight gain was noted in one animal while two animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
| Table 1. Results of eye irritation study. | ||||||||||
| Rabbit # | Time [h] | conjunctivae | iris | cornea | conjunctivae | iris | cornea | |||
| redness | swelling | redness | swelling | |||||||
| 1 | 1 | 1 | 0 | 0 | 0 | |||||
| 24 | 0 | 0 | 0 | 0 | ||||||
| 48 | 0 | 0 | 0 | 0 | ||||||
| 72 | 0 | 0 | 0 | 0 | ||||||
| average | 0.0 | 0.0 | 0.0 | 0.0 | Time to reversion | 0.0 | 0.0 | 0.0 | 0.0 | |
| 2 | 1 | 2 | 1 | 0 | 0 | |||||
| 24 | 1 | 1 | 0 | 0 | ||||||
| 48 | 1 | 0 | 0 | 0 | ||||||
| 72 | 0 | 0 | 0 | 0 | ||||||
| average | 0.7 | 0.3 | 0.0 | 0.0 | Time to reversion | 72.0 | 48.0 | 0.0 | 0.0 | |
| 3 | 1 | 1 | 1 | 0 | 0 | |||||
| 24 | 1 | 0 | 0 | 0 | ||||||
| 48 | 0 | 0 | 0 | 0 | ||||||
| 72 | 0 | 0 | 0 | 0 | ||||||
| average | 0.3 | 0.0 | 0.0 | 0.0 | Time to reversion | 48.0 | 0.0 | 0.0 | 0.0 | |
| Time [h] | conjunctivae | iris | cornea | |||||||
| redness | swelling | avg. time to reversion | 40.0 | 16.0 | 0.0 | 0.0 | ||||
| average score |
1 | 1.33 | 0.67 | 0.00 | 0.00 | |||||
| 24 | 0.67 | 0.33 | 0.00 | 0.00 | ||||||
| 48 | 0.33 | 0.00 | 0.00 | 0.00 | ||||||
| 72 | 0.00 | 0.00 | 0.00 | 0.00 | ||||||
| 24+48+72 | 0.33 | 0.11 | 0.00 | 0.00 | ||||||
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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