Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-03-27 to 2000-04-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
No certificate

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aldehyde C16 so-called; ethyl-2,3-epoxy-2-methyl-3-phenylpropionate-3-methyl-3-phenyloxiranecarboxylic acid ethyl ester.
- Substance type: Colourless to slight yellowish liquid
- Physical state: Liquid
- Analytical purity: Not specified but described as undiluted.
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Batch No: 50530043
- Expiration date of the batch: 300 days
- Stability under test conditions: 300 days
- Storage condition of test material: Cool and dry
- Other: Information supplied by sponsor

Test animals / tissue source

Species:
rabbit
Strain:
other: Chbb:HM(SPF) Littlerussian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach, Baden-Württemberg, Germany
- Age at study initiation: No data
- Weight at study initiation: 2.3 kg to 2.6 kg body weight
- Housing: Individually in PPO cages (floor area: 2576 cm²)
- Diet: Ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 °C
- Humidity (%): 55 % ± 15 %
- Air changes: 10 times per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Volume applied: 0.1 mL
Duration of treatment / exposure:
24 hr
Observation period (in vivo):
72 hr (observations at 1 hr, 24 hr, 48 hr, 72 hr)
Number of animals or in vitro replicates:
4 female
Details on study design:
APPLICATION
- Test material applied by pulling lower eyelid away from the eye to form a cup into which the test material was dropped.
- Test material applied to left eye (right eye served as control)
- After application, eyelids held together gently for 1 s.

ASSESSMENT:
- Day prior to the beginning of testing, both eyes were examined with a hand-held inspection lamp fitted with a white and UV-light and magnifying glass with a 2 × magnification to ensure no prior defects or irritation.
- Fluorescein added after the first 24hr reading. After rinsing with 20 mL 0.9 % sodium chloride solution the eyes were examined again using UV light to detect possible corneal damage.
- Scoring system: Standard Draize system.

SENTINEL
Rabbit 1724 was used as a sentinel.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1724
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: 1274
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 1274
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
chemosis score
Basis:
animal: 1274
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
cornea opacity score
Basis:
animal: 1664
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: 1664
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 1664
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
chemosis score
Basis:
animal: 1664
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
cornea opacity score
Basis:
animal: 1665
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: 1665
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: 1665
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
conjunctivae score
Basis:
animal: 1665
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
cornea opacity score
Basis:
animal: 1666
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: 1666
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 1666
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr
Irritation parameter:
chemosis score
Basis:
animal: 1666
Time point:
other: Mean of 24 hr, 48 hr, 72 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hr

Any other information on results incl. tables

Observations at 1 hr:

Animal Response
1724 Diffuse, crimson red conjunctiva with individual vessels not easily discernible, swelling above normal, discharge different from normal.
1664  Some conjunctival vessels definitely injected, swelling above normal, discharge with moistening of the lids and hairs just adjacent to lids.
1665 Some conjunctival vessels definitely injected, swelling above normal, discharge different from normal. 
1666 Diffuse, crimson red conjunctiva with individual vessels not easily discernible, swelling above normal, a discharge with moistening of the lids and hairs just adjacent to the lids.

Observations at 24 hr:

Animal Response
1724 Some conjunctival vessels definitely injected, swelling above normal
1664 Some conjunctival vessels definitely injected, swelling above normal
1665 Some conjunctival vessels definitely injected
1666 Some conjunctival vessels definitely injected, swelling above normal

At 48 hr and 72 hr all animals were free of any signs of eye irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found not to be irritating in an OECD 405 study.