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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:
1975-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) , the US Association of Food and Drug Officials (AFDO).
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
14 h/d light period. The eyes of three animals were washed after 30 s from treatment without justification.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: organic- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food (NAFAG, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
30 s (3 rabbits)
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water (3 animals)
- Time after start of exposure: 30 s

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 d
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 2 d
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 3 d
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 d
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
110
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The irritation index in this experiment was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.