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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 13. to 17. July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

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:
TEST ANIMALS
- Source: Charles River France Laboratories, Domaine des Oncins B.P. 0109, F 69592 L’Arbresle Cedex, France
- Age at study initiation: approximately 16 weeks
- Weight at study initiation: approximately 5 kg
- Housing: 1 per cage (during the study)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C+/-2 °C
- Humidity (%): 55%+/-15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): daily light/dark cycle of 12/12 hours

IN-LIFE DATES: From: 13. to 17. July 2015

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 g

Duration of treatment / exposure:
Only once. Exposure for 1 hour.
No rinsing of the treated eye was performed after dosing.
Observation period (in vivo):
1, 24, 48, 72 hours after dosing.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 1 hour
No rinsing of the treated eye was performed after dosing.

SCORING SYSTEM: Irritation to the cornea, iris and conjunctivae were assigned a numerical value according to the Draize scale.

TOOL USED TO ASSESS SCORE: macroscopic observation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation at either the conjunctivae, iris or cornea (score of 0) was recorded in any treated animal, during the whole observation period of the study (72 hours).
Other effects:
There was no indication of a systemic effect.
Blue staining of the fur around the treated eye, due to the colour of the test item, was noted in the animals during the whole observation period.
No signs of pain or distress were observed during the study.
No relevant changes in body weight were seen during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No signs of irritation were recorded in any treated animal during the observation period.
Executive summary:

The acute eye irritation of the test item was investigated in rabbits.

A 0.1 g aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed approximately 1, 24, 48, and 72 hours after dosing.

No irritation at either the conjunctivae, iris or cornea (score of 0) was recorded in any treated animal, during the whole observation period of the study (72 hours).

There was no indication of a systemic effect.

Blue staining of the fur around the treated eye, due to the colour of the test item, was noted in the animals during the whole observation period.

There were no signs of pain/distress after dosing.

Changes in body weight were not remarkable.

These results indicate that the test item has no irritating effects on the eye of the rabbit.

European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would suggest the following:

Classification: No category

Signal word: No signal word required

Hazard statement: No hazard statement required