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Diss Factsheets

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 30 September 2014 to 22 October 2014
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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reactive Brown DYHY 0331/0334

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 10 months
- 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: approximately 7 months

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: 30 September2014 To: 22 October 2014

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.
Observation period (in vivo):
1, 24, 48, 72 hours, days 7, 14, 21 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

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 - < 1
Max. score:
3
Reversibility:
fully reversible within: 48 hours after dosing
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:
Slight redeness of conjuntivae (score of 1) observed at 1 and 24 hours after dosing in all treated animals. Slight chemosis of conjuntivae (score of 1) observed at 1 hour after dosing in all treated animals.
Other effects:
Dark staining of the conjunctivae was observed on Day 1 in one animal. This sign was no longer apparent at 48 hour post-dose observation.
Dark staining of the conjunctivae was also noted in the remaining two animals up to Day 14 post-dose (Day 15 of the study).

Any other information on results incl. tables

Clinical signs

A dark staining of the fur around the treated eye was noted in all animals up to the observation performed on Day 22 of the study. This sign was related to the dark colour of the substance.

There was no indication of a systemic effect.

Pain/distress signs

No signs of pain or distress were observed in the animals during the study.

Body weight

Changes in body weight, seen during the course of the study, were not remarkable.

Applicant's summary and conclusion

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

The acute eye irritation of Reactive Brown DYHY 0331/0334 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, 7, 14 and 21 days after dosing.

Slight redeness of conjuntivae (score of 1) observed at 1 and 24 hours after dosing in all treated animals. Slight chemosis of conjuntivae (score of 1) observed at 1 hour after dosing in all treated animals.

There were no signs of pain/distress after dosing.

Changes in body weight were not remarkable.

There was no indication of a systemic effect related to treatment.

These results indicate that the test item has no remarkable 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: Not required

Signal word: None indicated

Hazard statement: None indicated