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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:
1975-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP. Comparable to OECD 405, without recording of body weight and clinical signs.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No indication of the method used to examine ocular reactions. For three of the six rabbits, eyes rinsed after 30 seconds after the test substance application.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dioctadecyl 3,3'-thiodipropionate
EC Number:
211-750-5
EC Name:
Dioctadecyl 3,3'-thiodipropionate
Cas Number:
693-36-7
Molecular formula:
C42H82O4S
IUPAC Name:
dioctadecyl 3,3'-sulfanediyldipropanoate
Details on test material:
- Name of test material (as cited in study report): TK 10594 (IRGANOX PS 802)
- Substance type: Organic
- Physical state: Solid white granules

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Bred on the premises and maintained under a semi-barrier system
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.41 kg (males); 2.24 kg (females)
- Housing: Individually
- Diet (e.g. ad libitum): Ad libitum, commercial irradiated diet (Styles-Oxoid)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 1 w

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 14 / 10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
3 rabbits: eye lid held close for one second, no further washing
3 rabbits: eye lid held close for one second, then flushing with warm water for one minute
Observation period (in vivo):
72 h (examination after 1h, 6h, 48h and 72h)
Number of animals or in vitro replicates:
3 rinsed eyes
3 non-rinsed eyes
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Warm water for 1 m (3 animals out of 6)
- Time after start of exposure: 30 s

SCORING SYSTEM: Draize Score (cornea scores 0 - 4, iris scores 0 - 2, conjunctiva scores 0-4 for chemosis and 0 - 3 for redness and discharge)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 6h
Remarks on result:
other: no chemosis at later observation time points. Results based on animals with non-rinsed eyes.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 6h and 24h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: No redness observed at later observation time points. Results based on animals with non-rinsed eyes.
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 1 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 6 h
Remarks on result:
other: No further discharge observed at later observation time points. Results based on animals with non-rinsed eyes.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h, 24h, 48h and 72h
Score:
0
Max. score:
4
Remarks on result:
other: Results based on animals with non-rinsed eyes.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h, 24h, 48h and 72h
Score:
0
Max. score:
2
Remarks on result:
other: Results based on animals with non-rinsed eyes.
Irritant / corrosive response data:
No indication of eye corrosion observed.
Other effects:
Results are not different if the rinsed eyes are evaluated.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is a minimal eye irritant in the albino rabbit.

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