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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 December 08, 2017 to March 19, 2018
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)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Granja RG Suzano/SP, Brasil
- Age at study initiation: 10 weeks old
- Weight at study initiation: 2413.6 to 2616.7 g
- Housing: individually in stainless steel cages
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 22.8 to 23.0 °C
- Humidity (%): 50 to 64 %
- Photoperiod: 12-hrs dark / 12-hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
1 Hours
Observation period (in vivo):
Approximately 1, 24, 48, 72 hours after the application of test substance.
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #2
Time point:
24/48/72 h
Score:
0.33

Any other information on results incl. tables

Table 1. Initial and Final Weights of the Animals and Grading of Ocular Reactions Observed during the Test.

Animal #

01

02

03

Weight (g)

Initial

2413.6

2413.8

2616.7

Final

2775.6

2473.3

2751.7

Sex

Observation period

Hours

Hours

Hours

1

24

48

72

1

24

48

72

1

24

48

72

Cornea

Opacity

0

0

0

0

0

0

0

0

0

0

0

0

Area

0

0

0

0

0

0

0

0

0

0

0

0

Iris

Irite

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae

Hyperemia

1

0

0

0

1

0

0

0

1

1

0

0

Chemosis

2

1

0

0

2

1

0

0

2

1

0

0

Secretion

-

-

-

-

-

-

-

-

-

-

-

-

Lesion

Fluorescein retention

NR

-

-

-

NR

-

-

-

NR

-

-

-

+: Presence; -: Ausence; NR: Not realized

Table 2. Clinical Signs

Animal #

Clinical Signs / Period of Evaluation

01 hour

24 hours

48 hours

72 hours

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

0: None visual alterations observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 405 test method, Everzol SR98 showed that non-irritant to the eye. Therefore, Everzol SR98 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the BIOAGRI Study Plan for 16264.465.102.17. All the animals presented body weight gain during the observation period. The test was initially conducted using one New Zealand White rabbit. Because no severe ocular reaction was observed in the initial test, two additional New Zealand White rabbits were tested to confirm the response. Each animal received a 0.1 g dose of pure test item in the conjunctival sac of the right eye. After application the animals were examined the ocular reaction, behavioral and clinical alterations at approximately 1, 24, 48 and 72 hours. The untreated left eye was used as a negative control. The Everzol SR98 applied in tested eye of all rabbits caused hyperemia and chemosis and do not have retention of fluorescein sodium dye on the surface of the cornea. After the evaluation of 48 hours, there was regression of eyes reactions in tested eyes of all rabbits. After the evaluation of 72 hours, finalizing the study and all rabbits do not note any behavioral or clinical change related to treatment during the observation period.