Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-05 to 2008-07-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study report, test prepared according to request of Swiss authority

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Name: Me-3K4A2
Cas no.: 132900-75-5
Chemical name: Benzoic acid, 4-[4-[(1-oxo-2- propenyl)oxy]butoxy]-, 2-methyl-1,4-phenylene ester
Purpose: industrial chemical
Colour: beige
Physical state: powder
Stability in solution or suspension: probably stable
Special procedures for dose preparation: prepare freshly
Storage: at room temperature, protected from light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy New Zealand White Rabbits HsdIf:NZW.
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Three female animals were used. Body weight at the commencement of the study was >2.0 kg.
The animals were derived from a controlled full barrier maintained breeding system (SPF).
- Semi-barrier in an air conditioned room
- Temperature: 18 ± 3°C (recommendations of TVT, GV-SOLAS; see
References)
- Relative. humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Certificates of food, water and bedding are filed at testing facility
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatization period (at least 5 days)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A dose of 0.1 g of the test item was applied to the conjunctival sac of the eye.
Duration of treatment / exposure:
The eyes were examined for signs of irritation throughout the observation period.
For calculation only the 24 h, 48 h and 72 hour readings were used.
Observation period (in vivo):
The animals were observed for 72 hours after dosing.
Number of animals or in vitro replicates:
3
Details on study design:
The test item was applied in a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Remarks on result:
other: none
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Remarks on result:
other: none
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: all
Score:
0.9
Max. score:
1.67
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: none
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0.67
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: none
Irritant / corrosive response data:
Initial Test (In Vivo Eye Irritation/Corrosion Test Using One Animal)
The in vivo test was performed initially using one animal.
As a corrosive effect was not observed in the initial test, the irritant or
negative response was confirmed using two additional animals.
 
Cornea: degree of density
(Opacity, area most dense taken for reading) Score
No ulceration or opacity                                                    0
Scattered or diffuse areas of opacity (other than slight
dulling of normal lustre), details of iris clearly visible      1
Easily discernible translucent area,
details of iris slightly obscured                                   2
Nacreous area, no details of iris visible,
size of pupil barely discernible                                   3
Opaque cornea, iris not discernible through the opacity         4
 
Iris Score
Normal                                                                              0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia, or injection; iris reactive to
light (a sluggish reaction is considered to be an effect)           1
Hemorrhage, gross destruction, or no reaction to light            2
 
 
Conjunctivae Score
Redness (refers to palpebral and bulbar conjunctivae:
excluding cornea and iris)
Normal                                                                             0
Some blood vessels hyperaemic (injected)                            1
Diffuse crimson colour, individual vessels not easily
Discernible                                                                        2
Diffuse beefy red                                                               3
 
Chemosis
Swelling (refers to lids and/or nictitating membranes) Score
Normal                                                                             0
Some swelling above normal                                                 1
Obvious swelling, with partial eversion of lids              2
Swelling, with lids about half closed                                      3
Swelling with lids more than half closed                                4
 
Discharge Score
No discharge                                                                    0
Any amount different from normal                                        1
Discharge with moistening of the lids and hairs adjacent to
Lids                                                                                   2
Discharge with moistening of the lids and hairs, and
considerable area around the eye                                          3
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is not irritating to eyes.
Executive summary:

Me3K4A2 was comminuted and administered to the conjunctival sac of eyes of 3 female New Zealand White Rabbits HsdIf:NZW at a concentration of 0.1 g according to OECD guideline 405. The untreated eyes of the rabbits served as a control. Limit values according to Directive 2001/59/EC. On the basis of the test results the substance was not classified. The substance showed only very slight effects on conjunctivae, not on iris or on the cornea. These effects were fully reversible within 3 days.