Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1982-11-29 to 1982-12-06
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment (TS identity)

Data source

Reference
Reference Type:
other: TSCA Document
Title:
Unnamed
Year:
1987
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: US EPA §163.81-5, Federal Register 43, 163, 22. Aug. 1978
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TK 13005
Physical state: solid
Batch No.: 41635-121081
no further details

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoering AG, CH- 4414, Fuellingsdorf, Switzerland
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: ad libitum, Rabbit food, NAFAG, No 814 Tox, NAFAG Grossau, Switzerland
- Water: ad libitum
- Acclimation period: 4 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
unspecified
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not performed

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Additionally, in 3 rabbits the treated eye was flushed 30 sec after application with 10 mL sterile physiological saline. One of these rabbits showed slight conjunctivae redness after 24 h but not at later time points (no effects on cornea and iris). No further effects in any of the other rabbits were observed.



Applicant's summary and conclusion