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:
14/01/1983-24/01/1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP (performed 1983), OECD conform, but experiment was stopped before all animals recovered

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation period terminated at day 7 although one animal still showed symptoms
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Measured for Batch: Density 0.976 g/ml; refraction index (20°C) = 1.571; nitrogen content 4.6%; further components quantified by gas chromatography
Specific details on test material used for the study:
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Storage condition of test material: room temperature

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: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 d
-Individual Identification: ear numbers

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
-CORNEA: non irritant = 0; slightly irritant = 1; irritant = 2; severely irritant = 3-4; corrosion = +
-IRIS: non irritant = 0; irritant = 1; severely irritant = 2; corrosion = +
-CONJUNCTIVEAE: non irritant= 0; slightly irritant = 1; irritant = 2; severely irritant = 3; corrosion = +
-CHEMOSIS: no swelling = 0; slight swellinig = 1; swelling = 2; severe swelling = 3-4

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
0
Max. score:
4
Remarks on result:
other: animal 37/m scored 1 at 1h and reversed to 0 at 24 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h and 7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks:
one animal with score of 1 on day 7
Remarks on result:
other: Two animals fully reversed after 7 days.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

cornea findings

animal no. 1 2 3
1h 0 0 0
24h 0 0 0
48h 0 0 0
72h 0 0 0

iris findings

animal no. 1 2 3
1h 0 0 0
24h 0 0 0
48h 0 0 0
72h 0 0 0

conjunctivae findings

animal no. 1 2 3
1h 1 2 2
24h 2 2 1
48h 2 1 1
72h 1 1 1
7 days 0 0 1

chemosis

animal no. 1 2 3
1h 1 0 1
24h 1 0 1
48h 1 0 1
72h 0 0 1
7 days 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met