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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:
Jan/Feb 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
EC Number:
264-796-3
EC Name:
2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
Cas Number:
64346-30-1
Molecular formula:
C23H29N2.C2H3O2
IUPAC Name:
2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
Test material form:
liquid
Details on test material:
Basic Violet 16

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK ltd. bzw. Intertauna UK ltd./Hack.a.Church
- Age at study initiation: Adult rabbits
- Weight at study initiation: Rabbit No.: G89 (3.1 kg); Rabbit No.: F93 (3.1 kg) and Rabbit No.: F94 (2.9 kg)
- Housing: Animals were individually housed
- Diet (ad libitum): sniff K4 standard diet
- Water (ad libitum): tap water
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45-65
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: January/February 1986

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Solution of NaCl
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 d
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
3.1
Max. score:
4
Reversibility:
not reversible
Remarks:
in one animal score 1 war present on day 21
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 d
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
A positive fluorescein test was seen until day 14.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance did induce irreversible eye effects.