Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 9 October 2017
Deviations:
yes
Remarks:
Deviations: only 2 animals instead of three; in one animal the eye was washed out immediately after treatment (TG: after 24 hrs)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed

Test animals / tissue source

Species:
rabbit
Strain:
other: Hra:(NZW)SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products lnc. (Denver, PA)
- Age at study initiation: at least three months old
- Weight at study initiation: at least 2000 g
- Housing: individually housed in suspended, stainless-steel mesh cages in an American Association for Accreditation of Laboratory Animal Care-accredited vivarium
- Diet: certified High Fiber Rabbit Diet (PMI® #5325) available ad libitum
- Water: local public water system available ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 46-62
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
One of the treated eyes was immediately washed with running distilled water
Observation period (in vivo):
Eyes were observed immediately after instillation of the test substance and 1, 24, 48, and 72 hours, and 7, 14, 21, and 28 days thereafter.
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: One of the treated eyes were immediately washed with running distilled water.

SCORING SYSTEM: Graded as described in OECD Guideline 405 (Annex V., Test B.5) (Grading for Ocular Lesions)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
unwashed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Remarks:
unwashed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 28 days
Irritation parameter:
chemosis score
Remarks:
unwashed eyes
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
For the unwashed eye, chemosis (grade 4) for the conjuctiva and a profuse discharge was noted one hour after administration of the test substance.
Signs of irritation for the unwashed eye between the 24 and 72 hour examination included corneal opacity (grade 1), redness of the conjunctiva (grade 3) and chemosis (grade 3) of the nictitating membrane/or lids. In addition, staining of the cornea and conjunctiva were apparent for the unwashed eye when fluorescein dye was applied at the 24-hour examination. Since the test substance caused significant ocular lesion within 72 hours after exposure which persisted for more than 24 hours, these changes were considered sufficient to characterize the response as irritating to eyes.
Other effects:
- Lesions and clinical observations: Animals were not weighed as weights are not critical to this study.
- Ophthalmoscopic findings: None reported
- Histopathological findings: No necropsies were conducted at the conclusion of the observation period.
- Effects of rinsing or washing: Immediate irrigation of the eye was palliative. For the washed eye, signs of irritation were limited to redness (grade 2) and chemosis (grade 2). A profuse discharge was also seen one hour after administration of the test substance. No staining was evident when fluorescein dye was applied. By Day 7 of the study, the washed eye appeared normal.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS Category 1 (H318) according to Regulation (EC) No 1272/2008
Conclusions:
In an in vivo eye irritation study (OECD 405), significant irritation was observed that was not reversible until day 21 of the study. The available data on eye irritation of the substance meet the criteria for classification as serious eye damage/eye irritation Cat. 1 (H318) according to Regulation (EC) 1272/2008.