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EC number: 204-794-1 | CAS number: 126-58-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05.06. 2015 to 22.10.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- October 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol
- EC Number:
- 204-794-1
- EC Name:
- 2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol
- Cas Number:
- 126-58-9
- Molecular formula:
- C10H22O7
- IUPAC Name:
- 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)propane-1,3-diol]
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dipentaerythritol (2,2,2’,2’-tetrakis(hydroxymethyl)-3,3’-oxydipropan-1-ol)
- Physical state: crystalline powder
- Analytical purity: 94.6%
- Lot/batch No.: 150300133
- Expiration date of the lot/batch: 03 Mar 2017
- Storage condition of test material: ambient/dark
- pH: 4.53
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK, Oxon, England
- Age at study initiation: 12-15 weeks
- Weight at study initiation: 3.2-3.3 kg
- Housing: individually in appropriately sized stainless steel cages with a ‘Noryl’ dual level interior and perforated floor. Beneath each cage was a suspended tray containing absorbent paper. Objects for chewing were placed in each cage, and the cages contained a shelter for hiding in.
- Diet (e.g. ad libitum): Harlan diet, ad libitum
- Water (e.g. ad libitum): water from the public supply, ad libitum
- Acclimation period: up to 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (target 16-20°C
- Humidity (%): 49-69% (target 40-70%)
- Air changes (per hr): at least 10/h (100% fresh air)
- Photoperiod (hrs dark / hrs light): 12 hour cycle
IN-LIFE DATES: From: 13 July 2015 To: 23 July 2015
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye remained untreated to serve as a control
- Amount / concentration applied:
- The test substance was administered as supplied. The weight equivalent of 0.1 mL was determined at the Test Facility and this weight was 79 mg.
- Duration of treatment / exposure:
- Not applicable - each animal received a single dose of the test substance, instilled into the lower conjunctival sac of the right eye. The lids were gently held closed together for 1-2 seconds.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing was not performed
SCORING SYSTEM: The scoring system detailed in OECD 405 (2012) was used; observations were made at 1, 4, 24, 48 and 72 hours after instillation.
TOOL USED TO ASSESS SCORE: hand-held magnifier and pen torch where necessary.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There was no irritation noted at the cornea, iris or conjunctivae, and no ocular discharge was noted in either animal at any observation timepoint.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
There was no irritation noted at the cornea, iris or conjunctivae, and no ocular discharge was noted in either animal at any observation timepoint. The mean values for each lesion, corneal opacity, iris, conjunctival redness and conjunctival chemosis were 0 (zero).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not irritating to rabbit eyes and classification is not required.
- Executive summary:
The eye irritation potential of Dipentaerythritol was evaluated in New Zealand White rabbits according to OECD guideline 405. Two female rabbits were treated with the weight equivalent of 0.1 mL; determined to be 79 mg, of Dipentaerythritol, instilled into the lower conjunctival sac of the right eye. The left eye remained untreated and hence it acted as a control. Both eyes were examined for evidence of irritation approximately 1, 4, 24, 48 and 72 h after instillation. There was no irritation noted at the cornea, iris or conjunctivae, and no ocular discharge was noted in either animal at any observation timepoint. In conclusion, the instillation of Dipentaerythritol did not cause any ocular irritation to the rabbit eye. Based on the results of this study, Dipentaerythritol does not require classification for eye irritation according to CLP criteria.
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