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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:
14 September to 09 October 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

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
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
UK GLP Compliance Programme (inspected on June 17, 2015 / signed on September 24, 2015)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: White crystalline powder
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 3.04-3.42 kg
- Housing: Animals were housed individually in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Envigo RMS (UK) Limited, Oxon, UK), ad libitum.
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 changes/h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: 14 September to 09 October 2015

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (approximately 92 mg)
- Concentration: undiluted
Duration of treatment / exposure:
No washing was done.
Observation period (in vivo):
1, 24, 48 and 72 h after instillation of test item
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize scale as described in the OECD guideline No. 405.

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:
animal: #1, #2 and #3
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
other: mean 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2 and #3
Time point:
other: mean 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
other: mean 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
- No corneal or iridium effects were noted during the study.
- Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Moderate conjunctival irritation was noted in two treated eyes and minimal conjunctival irritation was noted in one treated eye at the 24 hour observation with minimal conjunctival irritation noted in all treated eyes at the 48 hour observation.
- All treated eyes appeared normal at the 72 hour observation.
- The individual mean scores for corneal opacity and iritis was 0.0 for all animals. The individual mean scores for the conjunctivae were 1.0/1.0/1.0 for reddening and 0.3/0.7/0.7 for chemosis.
Other effects:
One animal showed no gain in body weight and two animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Table 7.3.2/1: Irritant/corrosive response data each animals at each observation time

Score at time point / Reversibility

Cornea Opacity

(/4)

Iris

(/2)

Conjunctivae

Redness

(/3)

Chemosis

(/4)

Discharge

(/3)

1 h

0 / 0 / 0

0 / 0 / 0

2 / 2 / 2

1 / 2 / 2

1 / 1 / 1

24 h

0 / 0 / 0

0 / 0 / 0

2 / 2 / 2

1 / 1 / 1

0 / 1 / 1

48 h

0 / 0 / 0

0 / 0 / 0

1 / 1 / 1

0 / 1 / 1

0 / 0 / 0

72 h

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

0 / 0 / 0

Average 24, 48 and 72 h

0.0 / 0.0 / 0.0

0.0 / 0.0 / 0.0

1.0 / 1.0 / 1.0

0.3 / 0.7 / 0.7

0.0 / 0.3 / 0.3

Reversibility

-

-

completely reversible

completely reversible

completely reversible

Average time for reversion

-

-

72 h

72 h

48 h

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test item is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an eye irritation study performed according to the OECD Guideline No. 405, and in compliance with GLP, 0.1 mL (approximately 92 mg) of test item was instilled into the right eye of three male New Zealand White rabbits. The left eye remained untreated and served as control. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test item, and then released. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.

No corneal or iridium effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Moderate conjunctival irritation was noted in two treated eyes and minimal conjunctival irritation was noted in one treated eye at the 24 hour observation with minimal conjunctival irritation noted in all treated eyes at the 48 hour observation. All treated eyes appeared normal at the 72 hour observation.

The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 /1.0 /1.0 for redness, 0.3 /0.7 /0.7 for chemosis, 0/0/0 for iris lesions and 0/0/0 for corneal opacity.The effects observed were all reversible within 72 hours.

 

Under the test conditions, the test item is not classified as irritating to eyes according to the criteria of the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.