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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:
Start: 2000-01-10 End: 2000-01-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2-{2,4-dihydroxy-5-[2-(4-hydroxyphenyl)propan-2-yl]phenyl}propan-2-yl)phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
Molecular formula:
C34H30N2O7S
IUPAC Name:
4-(2-{2,4-dihydroxy-5-[2-(4-hydroxyphenyl)propan-2-yl]phenyl}propan-2-yl)phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
Constituent 2
Chemical structure
Reference substance name:
4-[2-(2,4-dihydroxy-5-{2-[4-({[6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl]propan-2-yl}phenyl)propan-2-yl]phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
Molecular formula:
C44H34N4O10S2
IUPAC Name:
4-[2-(2,4-dihydroxy-5-{2-[4-({[6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalen-1-yl]sulfonyl}oxy)phenyl]propan-2-yl}phenyl)propan-2-yl]phenyl 6-(-lambda5-diazynylidene)-5-oxo-5,6-dihydronaphthalene-1-sulfonate
Test material form:
solid
Details on test material:
Batch PW-9F-29

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River UK, Margate, Kent, England
- Age at study initiation: 9 weeks
- Weight at study initiation: 1422, 1902, 1863 gram respectively
- Housing: individually housed in labelled cages with perforated floors (Scanbur, Denmark)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany) approx. 100 g per day.
- Water: ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 26 mg
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Executive summary:

Single samples of approximately 26 mg of test substance (a volume of approximately 0.1 ml) were instilled into one eye of each of 3 rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test substance resulted in effects on the iris and conjunctivae. Irridial irritation (grade 1) was observed in one animal after 1 hour only. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 24 hours in one animal and within 48 hours in the other 2 animals.

Yellow staining of the fur on the head and paws, caused by the test substance, was noted during the observation period. Remnants of the test substance were present in the eyes of all animals on day 1.