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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:
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 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. Without recording of body weight and clinical signs.
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'-thiodipropionate
Details on test material:
- 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: Ad libitum, commercial irradiated diet (Styles-Oxoid)
- Water: Ad libitum
- Acclimation period: 1 week

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.