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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:
2012
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

Constituent 1
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

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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