Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29-10-2018 to 09-11-2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed under GLP. All relevant validity criteria were met.
Justification for type of information:
Information as to the availability of the in vivo study is provided in 'attached justification'.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
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 MAFF, 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
inspected: July 2017 ; signature: November 2017

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: Liquid
- Storage condition of test material: approximately 4ºC, in the dark, under nitrogen
- Other: colourless

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 12-52 weeks old
- Weight at study initiation: 2.990 - 3.052 kg
- Housing: individually housed in suspended metal cages; with environment enrichment
- Diet: certified rabbit food ad libitum
- Water: mains water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour 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
- Concentration (if solution): undiluted

Duration of treatment / exposure:
A volume of 0.1 mL of the test material, was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes.
Observation period (in vivo):
Ocular assessment was conducted at approximately 1, 24, 48 and 72 hours after instillation of the test substance, according to numerical evaluation.
Number of animals or in vitro replicates:
2 (1 m / 1 f). Testing was conducted sequentially. Number of replcates in accordance with the relevant OECD guideline.
Details on study design:
The study was performed in a stepwise manner and was started by treatment of a single rabbit. The other animals were treated in a similar manner after considering the degree of eye irritation observed in the first and/or second animal. As applicable.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
The irritation was assessed according to Draize (1977) numerical scoring system. At each observation period, the highest scores given were recorded. Any other ocular effects were also noted.

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

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:
4
Remarks on result:
other: mean; n=2
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: mean; n=2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72-hours
Remarks on result:
other: mean; n=2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
>= 0.3 - <= 0.7
Max. score:
4
Reversibility:
fully reversible within: 72-hours
Remarks on result:
other: mean; n=2
Irritant / corrosive response data:
No corneal effects were noted. No iridial inflammation was noted. Moderate conjunctival irritation was noted in treated eyes 1 hour after treatment with minimal conjunctival irritation noted at the 24 and 48 Hour observations. All treated eyes appeared normal at the 72 hours.
Other effects:
- Lesions and clinical observations: None reported.
- Ophthalmoscopic findings: Not applicable.
- Histopathological findings: Not applicable.
- Effects of rinsing or washing: Not applicable.
- Other observations: All females gained bodyweight during the study.

Any other information on results incl. tables

Table 1. Individual scores and mean scores for 24, 48 and 72 hours

Organism number

1

2

Time After Treatment

1 Hour

24 Hours

48 Hours

72 Hours

1 Hour

24 Hours

48 Hours

72 Hours

CORNEA

 

 

 

 

 

 

 

 

Degree of Opacity

0

0

0

0

0

0

0

0

Mean (24 – 72 h)

 

 

 

0.0

 

 

 

0.0

 

 

 

 

 

 

 

 

 

IRIS

0

0

0

0

0

0

0

0

Mean (24 – 72 h)

 

 

 

0.0

 

 

 

0.0

 

 

 

 

 

 

 

 

 

CONJUNCTIVAE

 

 

 

 

 

 

 

 

Redness

2

1

1

0

2

1

1

0

Mean (24 – 72 h)

 

 

 

0.7

 

 

 

0.7

 

 

 

 

 

 

 

 

 

Chemosis

1

1

1

0

1

1

0

0

Mean (24 – 72 h)

 

 

 

0.7

 

 

 

0.3

 

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test item is not irritating to the eye.
Executive summary:

The study was performed to OECD TG 405 and EU Method B.5 under GLP to assess the irritancy potential of the test item to the eye following a single application in the New Zealand White rabbit. A volume of 0.1 ml of the test item was placed into the conjunctival sac of one eye of two animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. A single application of the test item to the non-irrigated eye of two rabbits produced no corneal and iridial effects. Moderate conjunctival irritation was noted in treated eyes 1 hour after treatment with minimal conjunctival irritation noted at the 24 and 48 Hour observations. All treated eyes appeared normal at the 72 hours. Under the conditions of this study, the test item is not considered to be irritating to the eye.