Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1987-12-21 to 1987-12-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study reliable with restrictions Minor deviations with no effect on the results: - The stability of the test material was not stated. - According to the guideline, the temperature and relative humidity should be 20 +/- 3 °C and 30 to 70 %, respectively. In the report the ranges of the temperature and relative humidity were not stated. -According to the guideline, after recording the observatiosn at 24 hours, the eyes of any or all rabbits may be further examined with the aid of fluorecein. In this study sodium fluorescein was used at the 24 hour observation. -According to the guideline, describtion of any non-ocular effects should be noted. There were no indications, if such observations were made. - According to the guideline, any other lesions besides those of the conjunctivae, cornea and iris should be recorded. Such information was not found in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, adopted 1987-02-24
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Thio-Sul (Ammonium Thiosulfate solution)
- Physical state: A clear colourless liquid
- Analytical purity: 56.45 %
- Storage condition of test material: At room temperature
- pH: 7.0 - 8.5
No further information on the test material was stated.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, inc., Denver, Pennsylvania
- Housing: Rabbits were maintained individually in screen-bottomed hanging cages in temperature-controlled and humidity-monitored quarters.
- Diet: 120 g per day of Purina Certified High Fiber Rabbit Chow ® #5325
- Water (ad libitum): water
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Each rabbit received a 0.1-ml aliquot of the test material (equivalent to approx. 75 mg pure test substance) placed on the everted lower lid of the left eye with the right eye serving as the untreated control. The upper and lower lids were gently held together for 1 second to prevent loss of the test material and then released. The test material was agitated while dosing.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
No data
Observation period (in vivo):
72 hours; The treated eyes were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
3 males / 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
The treated eyes of all six animals were not washed after instillation of the test material.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: At 24 hours, sodium fluorescein was used to aid in revealing possible corneal injury. The control eye on each animal was also stained at 24 hours for comparison with the test eye.
No further information on the study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: The mean value is based on the examination of six rabbits.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: The mean value is based on the examination of six rabbits.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.56
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The mean value is based on the examination of six rabbits.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The mean value is based on the examination of six rabbits.
Irritant / corrosive response data:
All the animals exhibited excessive blinking/rubbing upon instillation of the test material and all the fluorescein examinations wer negative at the 24-hour interval. No cornea opacity was observed in any of the animals during the study. Iritis (grade 1) was noted in one animal at the 1-hour interval only. Conjunctival redness (grade 1) was observed in all animals at the 1- and 24 hour intervals, then persisted in four animals at 48 hours. Chemosis (grade 2) was noted in four animals and grade 1 in two animals at the 1-hour interval and persisted as Grade 1 in two animals at 24 hours. Discharge Grade 1(any amount different from normal (does not include small amounts observed in inner canthus of normal animals)) or 2 (Discharge with moistening of the lids and hairs just adjacent to lids)) was noted n all the animals at the 1 hour interval only. Eye irritation in all the animals cleared by 72 hours.
See "Any other information on results incl. tables" for animal data.

Other effects:
No data

Any other information on results incl. tables

Irritation parameter

Basis

Time point

Score

Max. score

Reversibility

Remarks

Cornea score

Mean animal #1

24, 48, and 72 hours

0

4

 

 

Iris score

Mean animal #1

24, 48, and 72 hours

0

2

 

 

Conjunctivae score

Mean animal #1

24, 48, and 72 hours

0.66

3

Fully reversible within: 72 hours

 

Chemosis score

Mean animal #1

24, 48, and 72 hours

0.33

4

Fully reversible within: 48 hours

 

Cornea score

Mean animal #2

24, 48, and 72 hours

0

4

 

 

Iris score

Mean animal #2

24, 48, and 72 hours

0

2

 

 

Conjunctivae score

Mean animal #2

24, 48, and 72 hours

0.66

3

Fully reversible within: 72 hours

 

Chemosis score

Mean animal #2

24, 48, and 72 hours

0

4

 

 

Cornea score

Mean animal #3

24, 48, and 72 hours

0

4

 

 

Iris score

Mean animal #3

24, 48, and 72 hours

0

2

 

 

Conjunctivae score

Mean animal #3

24, 48, and 72 hours

0.33

3

Fully reversible within: 48 hours

 

Chemosis score

Mean animal #3

24, 48, and 72 hours

0.33

4

Fully reversible within: 48 hours

 

Cornea score

Mean animal #4

24, 48, and 72 hours

0

4

 

 

Iris score

Mean animal #4

24, 48, and 72 hours

0

2

 

 

Conjunctivae score

Mean animal #4

24, 48, and 72 hours

0.33

3

Fully reversible within: 48 hours

 

Chemosis score

Mean animal #4

24, 48, and 72 hours

0

4

 

 

Cornea score

Mean animal #5

24, 48, and 72 hours

0

4

 

 

Iris score

Mean animal #5

24, 48, and 72 hours

0

2

 

 

Conjunctivae score

Mean animal #5

24, 48, and 72 hours

0.66

3

Fully reversible within: 72 hours

 

Chemosis score

Mean animal #5

24, 48, and 72 hours

0

4

 

 

Cornea score

Mean animal #6

24, 48, and 72 hours

0

4

 

 

Iris score

Mean animal #6

24, 48, and 72 hours

0

2

 

 

Conjunctivae score

Mean animal #6

24, 48, and 72 hours

0.66

3

Fully reversible within: 72 hours

 

Chemosis score

Mean animal #6

24, 48, and 72 hours

0

4

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results, Thio-Sul is considered to be a non-irritant.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.