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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

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:
N-1-naphthylaniline
EC Number:
201-983-0
EC Name:
N-1-naphthylaniline
Cas Number:
90-30-2
Molecular formula:
C16H13N
IUPAC Name:
N-phenylnaphthalen-1-amine
Details on test material:
- Name of test material (as cited in study report): N-phenyl-alpha-naphtylamine (TK 11330)
- Physical state: solid, insoluble in water
- Analytical purity: commercial grade
- Batch No.: 9-10-86
- Other: Validity: October 1987; Safety precautions: gloves and face masks; Test material received: 1987-06-21

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks
- Weight at study initiation: 2510 to 2520 g
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum): standard rabbit pellet (Nafag No. 814, Switzerland); ad libitum; All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
- Water (e.g. ad libitum): fresh water; ad libitum; The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972).
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eyes of the test animals were used as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (36 mg)
Duration of treatment / exposure:
The test material was not removed.
Observation period (in vivo):
1, 24, 48 and 72 hour(s) after the instillation of test material.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
SCORING SYSTEM: OECD scoring system
TOOL USED TO ASSESS SCORE: slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
All control eyes were negative.
After 1 hour, chemosis was observed in animal #2 and animal #3, but was fully reversible within 24 hours.
Under the experimental condition, the test material was classified as not irritating to eyes.
Other effects:
A slight loss of body weight was observed in animal #2 on day 3 (table 1).

Any other information on results incl. tables

Table 1: body weights in g

 animal no.  #1 #2  #3 
 at start of test  2510 2510  2520 
 after 3 days 2550  2460  2620 
 after 7 days 2680  2610  2730 
 after 10 days (end) 2800  2600 (not clear because of the bad copy of the report)  2880

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
EU GHS criteria not met