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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:
Jun to Oct 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Lot no: 151105Purity - 101.39%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test animalsNew Zealand White rabbits were obtained from Harlan UK Ltd., Bicester (Hsdif:NZW strain). Weight at study initiation: 2.91 to 3.24 kg/dayHousing: Cages that conform with the "Code of Practice for the Housing and Care of Animals Used in Scientific Procedures" (Home Office, London, 1989) Diet: ad libitum supply of "Teklad Diet" animal feed Water: ad libitum supply of domestic mains water Acclimation period: 5 daysEnvironmental conditionsTemperature: 15 to 21C Humidity: 40 to 70%Air changes: 15 changes per hourPhotoperiod: 12 hours light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
100 mg powdered test article, dispensed from a foil sachet and instilled inot the left conjunctival sac of a New Zealand White rabbit.
Duration of treatment / exposure:
One dose consisting of 100 mg of powdered test article, dispensed from a foil sachet, instilled into the left conjunctiva! sac of a single New Zealand White rabbit. The lower eyelid was gently prised away from the eyeball to create a receptacle for the dose. After instillation the eyelids were held closed for a few seconds to prevent loss of the dose. The right eye remained untreated and served as a control to the treated eye.
Observation period (in vivo):
1, 24, 48 and 72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCEInformation on the method used to remove test material from eye post exposure was not documented in the reportSCORING SYSTEM: Table 1 GRADING OF OCULAR LESIONS from OECD guideline 405TOOL USED TO ASSESS SCORE: Use of 2% aqueous fluorescein solution to facilitate illumination with a UV source (adsorption of fluorescing dye would indicate epithelial damage.. Use of hand held magnifier and pen torch.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: redness (score 1) observed upto 1 hr
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: redness (score=1), chemosis (score =1) and discharge (score =2) observed upto 4 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: redness (score=1) chemosis (score =1) and discharge (score =1) observed upto 4 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no reaction
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no reaction
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no reaction
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Max duration: 1h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no reaction
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no reaction
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 1 day
Other effects:
Ocular instillation of the test substance provoked practically no initial sting reaction.No corneal opacification was noted. Iridial inflammation was noted in one treated eye 30 minutes after administration. Minimal to moderate conjunctival irritation was noted in all treated eyes lasting up to 4 hours after administration. All reactions had resolved by 24 hours after dosing.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article did not meet the criteria for classification as irritant or corrosive according to the EU Commission Regulation (EC) 1272/2008
Executive summary:

This study was conducted to determine the irritancy caused to the rabbit eye following a single instillation of the test article, Beta Ketosulfide, into the conjunctival sac.The test article (500mg:weight equivalent to 0.1mL) was instilled into one conjunctival sac of each of three New Zealand White rabbits on Day 1.Ocular reactions were assessed for up to three days after treatment.

Ocular instillation of the test article provoked practically no initialsting reaction. No corneal opacification was noted. lridial inflammation was noted in one treated eye 30minutes after administration. Minimal to moderate conjunctival irritation was noted in all treated eyes lasting up to 4 hours after administration. All reactions had resolved by 24 hours after dosing.

The test article did not meet the criteria for classification as irritant or corrosive according to the EU

Commission Regulation (EC)1272/2008