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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:
7 November to 10. November 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reaktiv-Rot F-66813 FW

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 to 5 months
- Weight at study initiation: 2.1 - 3.1 kg
- Housing: single
- Diet: Altromin 2123 maintenance diet ad libitum and approx. 15 g hay/day
- Water: deionized chlorinated water ad libitum
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 07 Nov. To: 10 Nov. 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm physiological saline solution
- Time after start of exposure: 24 hours

SCORING SYSTEM:
1, 24, 48, and 72 hours, then at 1 week post treatment

About 24 hours before the start of the study the eyes of all animals to be treated were examined under UV light for possible corneal lesions after instillation of one drop of a 0.01 % fluorescine-sodium solution. Only animals without ocular abnormalities were used for the study.
Every 100 mg Reaktiv-Rot F-66 813 FW was administered once into the conjunctival sac of the left eye of three rabbits. In each case, the untreated eye served as a control. 24 hours after the administration of the test substance and also at the designated examination times at which the treated eyes still showed discharge, or a corneal examination with fluorescine-sodium solution was performed the treated eyes were washed thoroughly with isotonic saline (approx. 37° C).

The eyes were examined 1, 24, 48 and 72 hours after administration of the test substance. After 24 and 72 hours the cornea was additionally examined under UV-light for corneal lesions after instillation of one drop of a fluorescine-sodium solution (0.01 %). Lesions in cornea, iris and conjunctivae were graded numerically. All other changes were recorded.


1. Conjunctivae

Redness: lids and/or nictitating membranes
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

Chemosis: lids and/or nictitating membranes
No swelling 0
Any amount different from normal (includes nictating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4


2. Iris
Normal 0
Markedly deepened rugae, congestion, swelling, slight
circumcorneal hyperaemia: or injection: iris still reacting to light
(a sluggish reaction is positive) 1
Haemorrhage, gross destruction, or no reaction to light. 2


3. Cornea

Opacity-degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight
dulling of normal lustre): details of iris clearly visible 1
Easily discernible translucent area: details of iris slightly obscured 2
Nacrous area: no details of iris visible: size of pupil barely discernible 3
Opaque cornea: iris not discernible through the opacity 4

Affected area (opacity or stained by fluorescine test)
No translucense 0
Punctiform to one quarter 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4


TOOL USED TO ASSESS SCORE: fluorescein staining and UV-light 24 and 72 hours after treatment

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
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:
cornea opacity 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
Irritant / corrosive response data:
One hour after administration the animals' conjunctivae showed a diffuse crimson color and swelling with about half closed lids. Reddish discolored discharge stained by the test substance occurred. All animals showed a pronounced hyperemia of several blood vessels of the conjunctiva 24 hours after administration.
All changes were fully reversible within 2 days.
Other effects:
The iris was sporadically red discolored during the whole course of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the present study, Reaktiv-Rot F-66 813 FW is not irritating to the eye. According to the classification criteria of Directive 83/467/EEC and the Ordinance on Hazardous Substances Reaktiv-Rot F-66 813 FW is not subject to labeling requirements.
Executive summary:

Testing for primary irritation in the rabbit eye provides information on ocular lesions after a single administration of the test substance to the conjunctival sac of the eye and serves as a basis for classification and labelling.

 

The present study was conducted according to EC-Guideline B.5. Acute Toxicity Eye Irritation of Directive 84/449/EEC: Commission Directive of April 25,1984 adapting for the sixth time Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of hazardous substances to the technical progressand meets the requirements ofOECD Guideline for Testing of Chemicals, 405 "Acute Eye Irritation / Corrosion", OECD 1981.Updated Guideline, adopted : 24th February 1987. Study conducted in compliance with GLP.

 

Based on the results of the present rabbit primary eye irritation studyReaktiv-Rot F-66813 FW is not irritating to the eye and not subject to labelling requirements.