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EC number: 270-336-2 | CAS number: 68425-16-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: JO RF 21/04/71 & 05/06/73
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Polysulfides, di-tert-nonyl
- EC Number:
- 270-336-2
- EC Name:
- Polysulfides, di-tert-nonyl
- Cas Number:
- 68425-16-1
- Molecular formula:
- C78H110O6S5
- IUPAC Name:
- bis(1,1,2,3,3-pentamethylbutyl)trisulfane
- Details on test material:
- Test compound: TPS 37
Chemical name: di-t-nonyl polysulfide
CAS no.: 68425-16-1
Source: Elf Aquitaine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: approximately 2.5 kg
- Housing: 540x360x315 mm cages individually housed or in restraining devices.
- Diet (e.g. ad libitum): 200 g granules per animal per day
- Water (e.g. ad libitum): ad libitum and automatically softened and filtrated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C minimum
- Air changes (per hr): 12 times per hour; pre-filtered
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye served as control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- Observations recorded at 1 hour, 24 hours, 2 days, 3 days, 4 days, and 7 days after administration.
When the irritation is persistent, readings are made each week over a maximum period of 5 weeks. - Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: not rinsed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Remarks:
- Scores at 72 hours were not given in the study report, but interpreted to be the same as the scores at 48 hours.
- Irritant / corrosive response data:
- Four of the 6 rabbits showed opacity of the cornea after the first hour of administration. Symptoms were fully reversible within 24 hours of test substance administration. Effects to the conjunctiva and iris were all scored at 1 or below and effects were fully reversible after 7 and 4 days, respectively. Chemosis was noted and scored as high as a 2 in some animals but was fully reversible by 7 days.
Any other information on results incl. tables
Conjuncitva:
No. of rabbits |
1 Hour |
24 Hours |
48 Hours |
|||||||||||||||
193 |
194 |
195 |
196 |
197 |
198 |
193 |
194 |
195 |
196 |
197 |
198 |
193 |
194 |
195 |
196 |
197 |
198 |
|
Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
1 |
1 |
1 |
1 |
Discharge |
2 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Enanithema |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
(A+B+C) x 2 (max. = 20) |
8 |
6 |
6 |
6 |
6 |
6 |
4 |
6 |
6 |
8 |
6 |
4 |
4 |
0 |
2 |
2 |
4 |
4 |
Iris:
No. of rabbits |
1 Hour |
24 Hours |
48 Hours |
|||||||||||||||
193 |
194 |
195 |
196 |
197 |
198 |
193 |
194 |
195 |
196 |
197 |
198 |
193 |
194 |
195 |
196 |
197 |
198 |
|
Congestion |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
X 5 (max. = 10) |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
0 |
5 |
5 |
0 |
0 |
5 |
0 |
Cornea:
No. of rabbits |
1 Hour |
24 Hours |
48 Hours |
|||||||||||||||
193 |
194 |
195 |
196 |
197 |
198 |
193 |
194 |
195 |
196 |
197 |
198 |
193 |
194 |
195 |
196 |
197 |
198 |
|
Opacity (0-4) |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area Affected (1-4) |
1 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
A x B x 5 (max. = 80) |
5 |
0 |
5 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Ulceration |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area Affected (a-d) |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
Granulation |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area Affected (a-d) |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
/ |
Individual ocular irritation score (max: 110) |
18 |
11 |
16 |
16 |
16 |
11 |
9 |
11 |
11 |
13 |
11 |
4 |
9 |
5 |
2 |
2 |
9 |
4 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an eye irritation test, the study authors found TPS 37 to be an eye irritant when based on the index of ocular irritation at 1 and 48 hours respectively. However, according to EU guidelines, TPS 37 is not an eye irritant based on the gained mean scores for conjunctiva, iris and cornea.
- Executive summary:
In an eye irritation test, six male albino New Zealand rabbits were exposed to 0.1mL of TPS 37 in the right eye. The left eye served as a control. Animals were observed at 1, 24, 48, 72, 86, and 168 hours after test substance administration. Scores for anomalies in the conjunctiva, alternations in pupil or iris, degree and extent of opacity of the cornea, and any ulceration or granulation of the cornea were scored and recorded for each animal during each observation point. The mean index of ocular irritation and index of acute ocular irritation (greatest mean index of ocular irritation) were calculated based on the methods of Kay and Calandra (1962) and used to classify the test substance. Mean conjunctiva, iris and cornea scores were calculated by averaging all of the animal scores from the 24-, 48-, and 72-hour observations points.
The study authors calculated the index of acute ocular irritation to be 14.67 after one hour of test substance administration. The index of ocular irritation after 48 hours was 5.17. Based on these values the study authors classified TPS 37 as irritating.
The mean conjunctiva, iris and cornea scores were 0.5, 0.61, and 0 respectively. All effects were fully reversible in 4 days for the iris and 7 days for the conjunctivae. Based on these results, TPS 37 is not classified according to EU guidelines.
This study received a Klimisch score of 2 because it generally follows OECD guideline 405.
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