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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:
weight of evidence
Study period:
From 8 April 2016 to 19 May 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

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
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Stabilisation: in water undergoes hydrolysis
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Analytical purity: 92%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at room temperature and humidity avoid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: from the conventional husbandry of the Institute of Occupational Medicine in Łódź
- Age at study initiation:5-month-old
- Weight at study initiation: At the beginning of the experiment, rabbit no. 1 weighed 3.85 kg, rabbit no. 2 weighed 4.72 kg and rabbit no. 3 weighed 4.71 kg.
- Housing: The animals were individually housed in metal cages. The dimensions of the cages were 73 x 70 x 45 cm (length x width x height). To environmental enrichment in each cage were placed wooden blocks for laboratory animals
- Diet (e.g. ad libitum): ad libitum access to the “LSK” standard granulated laboratory fodder (Batch no. 8/15, 1/16 and 2/16) produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum drinking tap water
- Acclimation period: The animals were quarantined and observed for 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): air-conditioned rooms, 20 – 23ºC
- Humidity (%): 33 – 53%
- Air changes (per hr): about 13 times/h
- 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 ml of the test item
- Concentration (if solution): 100%
Duration of treatment / exposure:
Applied once
Observation period (in vivo):
Detailed clinical observations for changes in the cornea, iris, and conjunctiva were performed 1, 24, 48 and 72 hours and 7 days after the application of the test item
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:

Corneal opacity score:
0- No ulceration or opacity
1- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2- Easily discernible translucent area, details of iris slightly obscured
3- Nacreous area, no details of iris visible, size of pupil barely discernible
4- Opaque cornea, iris not discernible through the opacity

Iris score
0-Normal
1-Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, iris reactive to light (a sluggish reaction is considered to be an effect)
2-Hemorrhage, gross destruction, or no reaction to light

Conjuntive redness score
0-Normal
1-Some blood vessels hyperaemic (injected)
2-Diffuse, crimson colour, individual vessels not easily discernible
3-Diffuse beefy red

Chemosis score (swelling)
0-Normal
1-Some swelling above normal
2-Obvious swelling, with partial eversion of lids
3-Swelling, with lids about half closed
4-Swelling, with lids more than half closed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 1
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1.3
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 0.3
Max. score:
1
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible within: 7d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritant / corrosive response data:
No irritant

Any other information on results incl. tables

Table 1: Evaluation of the animals' ocular lesions

Animal number

 

Part of the eye

 

Readings after

 

Average after 24, 48, and 72 hours

 

1 hour

 

24 hours

 

48 hours

 

72 hours

 

7 days

 

 

 

 

1

Cornea

 

0

0

0

0

0

0.0

Iris

 

0

0

0

0

0

0.0

Conjunctiva

erythema

 

2

1

1

1

0

1.0

swelling

 

2

1

0

0

0

0.3

 

 

 

2

Cornea

 

 

0

0

0

0

0

0.0

Iris

 

 

0

0

0

0

0

0.0

Conjunctiva

erythema

 

2

2

1

1

0

1.3

swelling

 

2

1

1

0

0

0.7

 

 

 

3

Cornea

 

 

0

0

0

0

0

0.0

Iris

 

 

0

0

0

0

0

0.0

Conjunctiva

erythema

 

2

2

1

1

0

1.3

swelling

 

2

2

1

0

0

1.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is not classified as irritant to the rabbit eye. After application of the test item, slightly changes in the conjunctiva of three rabbits were observed, but these changes were transient.

Executive summary:

The eye irritation potential of the test substance was determined in accordance with the OECD Nº 405 with GLP. VL3 was tested on three New Zealand female White rabbits (0.1ml/eye). Animals were observed at 24h, 48, 72 and 7 days after the test item was applied. The corneal opacity score, the iris score and the conjunctive score were recorded. No corneal opacity or iris damage were observed but a transient pathological changes in the conjunctiva of three rabbits were observed.. However, this effect was fully reversible within 7 days. The substance is not classified according to CLP Regulation since the corneal opacity was <1, the iritis <1, the conjunctival redness <2 and the conjunctival oedema (chemosis) <2, calculated as the mean scores following grading at 24, 48 and 72 hours after instillation of the test material and which fully reverses within an observation period of 7 days.