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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:
From 2018-06-21 to 2018-06-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2017
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Purity: > 99%
Batch No.: 102Z4

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Limited Company
- Age at study initiation: 84 days at receipt and 90 - 94 days at dosing
- Weight at study initiation: 1899.2 - 2009.1 g at receipt and 2233.4 - 2257.5 g at dosing
- Housing: in stainless wire cages (W 70 cm × L 80 cm × H 75 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 – 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9 °C
- Humidity (%): 47% - 72%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Details on study design:
TOOL USED TO ASSESS SCORE: binocular loupe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
The mean values of the three animals are 0, 0, 0, respectively.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
The mean values of the three animals are 0, 0, 0, respectively.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Remarks on result:
probability of weak irritation
Remarks:
The mean values of the three animals are 0, 0, 0, respectively. The maximum values of animals No. 1100 and 1102 are 1, 1.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
The mean values of the three animals are 0, 0, 0, respectively.
Other effects:
- Clinical Observations: No significant adverse systemic effect was observed in any animal during the study. The animals only showed excessive blinking at immediate observations after dosing.
- Eye Examination: There were no abnormalities for all eyes in eye examinations approximately 24 hours prior to dosing. There were no observable abnormalities in eye examinations for three control eyes at all observation intervals after administrations. The treated eyes of animal No. 1100 and 1102 showed some blood vessels hyperaemic (injected) at 1 hour after administration. All treated eyes showed no eye irritant reactions at 24, 48 and 72 hours after administration.
- Fluorescein Examination: There was no retention of fluorescein for three control and treated eyes at 24 hours before and after dosing.
- Body Weights: All animals showed expected gains in body weights during the study.

Any other information on results incl. tables

Eye reaction scoring:

Animal ID Eye reactions 1 h 24 h 48 h 72 h
1100 Cornea 0 0 0 0
Iris 0 0 0 0
Conjunctivae Redness 1 0 0 0
Conjunctivae Chemosis 0 0 0 0
1101 Cornea 0 0 0 0
Iris 0 0 0 0
Conjunctivae Redness 0 0 0 0
Conjunctivae Chemosis 0 0 0 0
1102 Cornea 0 0 0 0
Iris 0 0 0 0
Conjunctivae Redness 1 0 0 0
Conjunctivae Chemosis 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test subatnce could produce very slight eye irritant reactions in rabbit.
Executive summary:

The study was performed to assess the acute eye irritation/corrosion of the test substance in Japanese White rabbits in accordance with the OECD Guideline for the testing of chemicals: Acute Eye Irritation/Corrosion (TG 405, adopted October 9, 2017).

Three male rabbits were used for the study. Each animal was administered with 0.1 g of the test item into the right eye. Untreated left eye served as the control. Immediately after administration of the test item, the initial reaction was observed and recorded. Test animals were routinely observed and recorded for clinical signs of pain and/or distress and any adverse systemic effects except eye twice daily for 3 days after administration of the test item, with a minimum of 6 hours between observations. Both eyes of animals were examined by a binocular loupe at approximate 1, 24, 48 and 72 hours after administration. The ocular reactions and any other lesions in the eye were recorded at each examination. Fluorescein stain examination was used at approximate 24 hours after administration. Ocular lesions (cornea, iris, conjunctivae redness and chemosis) for treated eye of each animal were scored and recorded at each examination. Mean scores of ocular lesions at approximate 24, 48 and 72 hours after administration were calculated for treated eyes. Individual animal body weights were recorded on the day of dosing and the completion of the final symptom observations of eye irritation.

 

No significant adverse systemic effect was observed in any animal during the study. The animals only showed excessive blinking at immediate observations after dosing. There were no abnormalities for all eyes in eye examinations approximately 24 hours prior to dosing. There were no observable abnormalities in eye examinations for three control eyes at all observation intervals after administrations. The treated eyes of animal No. 1100 and 1102 showed some blood vessels hyperaemic (injected) at 1 hour after administration. All treated eyes showed no eye irritant reactions at 24, 48 and 72 hours after administration. There was no retention of fluorescein for three control and treated eyes at 24 hours before and after dosing. Body Weights: All animals showed expected gains in body weights during the study.

 

Based on above results, the test substance could produce very slight eye irritant reactions in rabbit, and was classified as unclassified according to GHS's classification criteria for the eye irritation.