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Diss Factsheets

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:
November 5, 2004 to January 24, 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and Test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
Principles of method if other than guideline:
This study was designed by referring to``Biological evaluation of medical devices. Part 10- test for irritation and delayed type hypersensitivity"(September l, 2002) Annex B“ Additional irritation tests''B.3 0culalar irritation test (abbreviated to lS0 10993 Part-10 Annex B), ("Principles For Blological Safety Evaluation of Medical Devices" (Pharmaceutical and Food Safety Bureau, Japanese Labour and Welfare, Notification lyakushinhatsu No.0213001, February 13,2003), and“
Guidance for Speciflc Blological Tests Relevant to the Principles lssued by the Notiflcation lyaktushinhatsu No.0213001"( Pharmecuatical and Food Safety Bureau, Japanese Labour and Welfare, Notification lyakushinhatsu No.35, March 19th, 2003.)
GLP compliance:
yes

Test material

Test material form:
liquid

Test animals / tissue source

Species:
other: Rabbit (Japanese white (Kbs:JW, clean))

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL per eye
Duration of treatment / exposure:
72 hrs
Observation period (in vivo):
Observation, Evaluation:

Both eyes. where observed with a slit-lamp at 1, 24,48 and 72 hrs after instillation and leslons in the cornea,iris and conjunctiva were graded in accordance with Draize method.

Fluorecsein Examination

Sodium Fluorecsein solution was instilled into both eyes of ali the cases at 24 hrs after instillation of test sample and stained spot on thc cornea was examined with slit-lamp.

Observation of General Conditions and Measurement ofvBody Weight.

Thc gencral conditlons of each animal were observed once a day and body weight of each animal were measured on the day of instillation and at 72 hours after instillation.

Photograph of Anterior segment of the eyes

When individual iriritation score was 6 or higher on the macrspoic examonation, and when the leslon changed,the eye was photographed.ln this stuidy, photographs were not taken because no animals showed 6 or higher individual irritation score.




Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):not done
- Time after start of exposure: 72 hours

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: max duration 48 hrs
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: max duration 48 hrs
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: max duration 24 hrs
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
Based on the irritation score obtained from these observations, the test article was judged to be non-irritant according to the irritation criteria of Draize.