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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:
10 August 2016 to ****
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), Testing Guidelines for Toxicology Studies, 12 NohSan No. 8147, amended 10 December 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
CAS RN: 15337-18-5
Purity: 96.6%
Physical state/Appearance: Yellow viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: Hsdlf:NZW
- Age at study initiation: 12 to 52 weeks old
- Weight at study initiation: 3.16 to 3.19 kg
- Housing: Individually in suspended cages
- Diet: Certified rabbit feed, ad libitum
- Water: Mains tap water, ad libitum
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23
- Humidity (%): 30 to 70
- Air changes (per hr): At least fifteen
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
72 hour
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (Draize, J.H, 1977).
Number of animals or in vitro replicates:
2
Details on study design:
Initially, a single rabbit was treated. A subcutaneous injection of a systemic analgesic was administered 60 minutes prior to test item application. Five minutes prior to test item application, a pre dose of ocular anesthetic was applied to each eye.

The test item was placed into the conjunctival sac of the right eye. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made.

Eight hours after test item application, a subcutaneous injection of post dose analgesia was administered to provide a continued therapeutic level of systemic analgesia. The treated animal was checked for signs of pain and suffering approximately 12 hours later. No further analgesia was required.

After consideration of the ocular responses produced in the first treated animal, a second animal was similarly treated. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. Any clinical signs of toxicity, if present, were also recorded. Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0.83
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Ocular Reactions

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes 1 hour after treatment with minimal conjunctival irritation noted at the 24 and 48-Hour observations. Both treated eyes appeared normal at the 72-Hour observation.

 

Body Weight

One animal showed body weight loss and the other animal showed expected gain in body weight during the study.

 

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex

75567 Male

75556 Male

IPR = 0

IPR = 0

Time After Treatment

1

24

48

72

1

24

48

72

Hour

Hours

Hours

Hours

Hour

Hours

Hours

Hours

CORNEA

-

-

E = Degree of Opacity

0

0

0

0

0

0

0

0

F = Area of Cornea Involved

0

0

0

0

0

0

0

0

Score (E x F) x 5

0

0

0

0

0

0

0

0

IRIS

-

-

D

0

0

0

0

0

0

0

0

Score (D x 5)

0

0

0

0

0

0

0

0

CONJUNCTIVAE

-

-

A = Redness

1

1

1

0

2

2

1

0

B = Chemosis

1

1

0

0

1

1

0

0

C = Discharge

2

0

0

0

2

0

0

0

Score (A + B + C) x 2

8

4

2

0

10

6

2

0

Total Score

8

4

2

0

10

6

2

0

IPR = Initial pain reaction

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals.
Executive summary:

The study was performed to assess the irritancy/corrosion potential of the test item to the eye of the New Zealand White rabbit.  A single application of the test item to the non-irrigated eye of two rabbits produced moderate conjunctival irritation.  Both treated eyes appeared normal at the 72 Hour observation.  The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals.