Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 June to 24 July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and OECD guideline compliant study with no deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
October 2012
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- 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:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hours
Score:
0
Max. score:
4
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.