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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:
Jan/Feb 1985 to 1985-05-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate
EC Number:
279-919-6
EC Name:
[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate
Cas Number:
82205-20-7
Molecular formula:
C21H29ClN5O3.C2H3O2
IUPAC Name:
N-{2-[{4-[(2-chloro-4-nitrophenyl)diazenyl]phenyl}(ethyl)amino]ethyl}-2-hydroxy-N,N-dimethylpropan-1-aminium acetate
Test material form:
liquid
Details on test material:
see below

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Hubtingdon, UK)
- Housing: one animal per cage under standardized conditions
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24 hours after instillation

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks:
erosion of cornea epithelium
Remarks on result:
positive indication of irritation
Remarks:
irreversible eye effect
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 d
Remarks on result:
not determinable
Remarks:
at 24 hours evaluation not possible, due to colouration by the test substance
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 48/72 h
Score:
0
Max. score:
2
Remarks on result:
not determinable
Remarks:
at 24 hours evaluation not possible, due to colouration by the test substance
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
other: 48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 d
Remarks on result:
not determinable
Remarks:
at 24 hours evaluation not possible, due to colouration by the test substance
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
not determinable
Remarks:
at 24 hours evaluation not possible, due to colouration by the test substance
Irritant / corrosive response data:
The cornea opacity in animal 1 was score 1 between 1 and 72 hours. At 72 hours, the cornea epithelium developed an erosion. Between Day 7 and Day 21, the cornea opacity was score 3 and the erosion developed into a deformed cornea.

Any other information on results incl. tables

Table 1: Results of the test
  Draize grade
Animal number Endpoint 24 h 48 h 72 h 7d 14d 21d mean (24, 48, 72 h)
1 Cornea 1 1 1* 3* 3* 3* 1
2 1 2 2* 0 0 - 1.67
3 1 1 1 0 0 - 1
4 2 2 2 0 0 - 2
1 Iris 0 0 0 1 0 0 0
2 x 1 1 0 0 - -
3 x 0 0 0 0 - -
4 1 1 1 0 0 - 1
1 Conjunctivae 2 2 2 2 2 0 2
2 x 2 2 0 0 - -
3 x 2 2 0 0 - -
4 x 3 3 1 0 - -
1 Chemosis 2 1 0 0 0 0 1
2 2 2 1 0 0 - 1.67
3 2 1 1 0 0 - 1.33
4 2 2 1 0 0 - 1.67

*= erosion of the cornea epithelium

x= not analysed due to colouration by the test substance

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
In an acute eye irritation/corrosion study according to OECD 405, the test substance causes non-reversible effects on the cornea of one animal.
Executive summary:

In a primary eye irritation study, 0.1 mL of the test item (target substance content 57.2 %) was instilled into the conjunctival sac of one eye of each of four female New Zealand White rabbits for 24 hours, and subsequently washed out with physiological saline. The animals were observed for a period of 72 hours. Irritation was scored by the method by Draize. In this study, the test item induced irreversible effects on the cornea of one animal, meaning that the adverse effects have not reversed within an observation period of 21 days.