Registration Dossier

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:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is reliable with restrictions because it follows a guideline similar to OECD 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: JO RF 21/04/71 & 05/06/73
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test compound: TPS 37
Chemical name: di-t-nonyl polysulfide
CAS no.: 68425-16-1
Source: Elf Aquitaine

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:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: fully reversible for all but one animal in 4 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.61
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
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:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation test, study authors found TPS 37 to be an eye irritant.
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.