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:
April/May 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
not specified
Remarks:
but parallel running acute oral study was conducted under GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Reactive Yellow 160

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrung, konventionelle Zucht
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: single
- Diet (e.g. ad libitum): Altromin 2013 Zuchtdiät - Kaninchen (Altromin GmbH, Lage/Lippe), ad libitum

- Water (e.g. ad libitum): deionized (ad libitum)
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From April 12 to April 15,1983

Test system

Vehicle:
physiological saline
Remarks:
pasted with 0.04 mL
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours
0, 24, 72 h under UV light after fluorescein instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): ca 37°C warm physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein, UV light

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:
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
Irritation parameter:
chemosis 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:
The florescein test was negatve on all occasions. Slight effects on conjunctiva (and iris) were only observed 1 hour after test item application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the test substance was determined to be not irritant to rabbit eye.
Executive summary:

A study was conducted to determine the in vivo eye irritation potential of the test substance according OECD Guideline 405 and EU Method B.5. Three rabbits (New-Zealand White) were exposed to the test substance for 24 h. The observation period covered the following 72 h. Conjunctival redness and swelling, as well as cornea opacity and iris irritation were assessed in the rabbits. The mean score at 24, 48, and 72 h after test substance application for all parameters were 0. Under the study conditions, the test substance was determined to be not irritating to rabbit eye.