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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-11-2011 to 22-11-2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids
Molecular formula:
Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.
IUPAC Name:
Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.16 - 2.67 kg
- Age: 12-20 weeks
- Housing: individual, suspended cages
- Diet: ad libitum, 2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water: ad libitum
- Acclimation period: 5 days at least

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- - Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: control: left untreated eye of each test animal
Amount / concentration applied:
0.1 mL of the test material (approximately 99 mg) was placed into the conjunctival sac of the right eye while the left eye served as control.
Duration of treatment / exposure:
exposure to test material not limited, not rinsed after application
Observation period (in vivo):
assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE:
no

SCORING SYSTEM:
according to Draize (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).

TOOL USED TO ASSESS SCORE:
examination of the eye was facilitated by the use ofthe light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a.
Irritation parameter:
iris score
Basis:
animal: #1, #2
Time point:
other: 1 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal: #1, #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
2
Reversibility:
other: n.a.
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
other: 1 h, 24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
other: 48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
other: 72 h
Score:
0
Max. score:
3
Reversibility:
other: n.a.
Irritation parameter:
chemosis score
Basis:
animal: #1, #2
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2
Time point:
other: 24 h, 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a.
Irritation parameter:
other: discharge score
Basis:
animal: #1, #2
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
other: discharge score
Basis:
animal: #1, #2
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
other: discharge score
Basis:
animal: #1, #2
Time point:
other: 48 h, 72 h
Score:
0
Max. score:
3
Reversibility:
other: n.a.
Irritant / corrosive response data:
The test substance produced scattered or diffuse corneal opacity and iridial inflammation in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in both treated eyes one and 24 hours after treatment with minimal conjunctival irritation noted at the 48 hour observation. Both treated eyes appeared normal at the 72 hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008) and DSD (Directive 67/548/EEC)
Conclusions:
Based on the results of this study, the test substance was determined to be non-irritant to the eye. According to the criteria of OECD GHS, Regluation (EC) 1272/2008 and of DSD (Directive 67/548/EEC) no classification and labelling is required.
Executive summary:

In a primary eye irritation study performed according to the testing guideline OECD 405 0.1 mL (99 mg) of  Sucroglyceride C12-18, C18unsatd. (92.66% a.i.) was instilled undiluted into the conjunctival sac of one eye of 2 young adult New Zealand White rabbits. Eyes were not washed. Animals then were observed for 72 hours. Irritation was scored by the method of Draize.

Scattered or diffuse corneal opacity and iridial inflammation in both treated eyes one hour after treatment. Moderate conjunctival irritation was noted in both treated eyes one and 24 hours after treatment with minimal conjunctival irritation noted at the 48 hour observation. All observed effects were completely reversible within 72 hours and both treated eyes appeared normal at the 72 hour observation.

In this study, Sucroglyceride C12-18, C18unsatd. (93.66% a.i) is not an eye irritant.