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EC number: 205-286-2 | CAS number: 137-26-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Apr - 1 May 1985
- 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:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2021
- Deviations:
- yes
- Remarks:
- methodological limitations (e.g. individual body weight at study termination was not reported, no anesthetic/analgesic pretreatment performed)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Thiram
- EC Number:
- 205-286-2
- EC Name:
- Thiram
- Cas Number:
- 137-26-8
- Molecular formula:
- C6H12N2S4
- IUPAC Name:
- thiram
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cpb/TNO, Zeist, The Netherlands
- Age at study initiation: adult, not further specified
- Weight at study initiation: 3591 - 3567 g (4 days before administration of the test susbtance)
- Housing: individually in metal cages with perforated floors
- Diet: standard laboratory diet (Hope Farms, Woerden), pelleted diameter 4 mm, 100 g per animal and day
- Water: tap water, ad libitum
- Acclimation period: at least 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 45 - 65
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 Apr 1985 To: 1 May 1985
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 g per animal
- Duration of treatment / exposure:
- eyes were not rinsed
- Observation period (in vivo):
- 15 days
Observations were performed immediatly after instillation of the test substance, and approximatly 1, 24, 48 and 72 h and 7 and 15 days after instillation of the test substance. - Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: none
SCORING SYSTEM:
Grades of ocular lesions: Cornea
Degree of Opacity 0 – 4 (0 = no finding, 1 = slight, disperse, diffuse opacity, 2 = extensive, diffuse opacity, iris blurred, 3 = nacreous areas, no details of iris visible, size of pupil hardly discernible, 4 = opaque cornea, iris not discernible through the opacity)
Iris 0 – 2 (0 = no finding, 1 = swelling, reddening, positive light reaction, 2 = severe reddening and swelling, no light reaction)
Conjunctivae
Redness 0 – 3 (0 = blood vessels normal, 1 = vessels abnormally filled, 2 = diffuse reddening, 3 = diffuse deep reddening)
Chemosis 0 – 4 (0 = no swelling, 1 = slight swelling, 2 =severe swelling, lids everted, 3 = lids cover one half of eye, 4 = lids cover more than half eye, necroses and ulcers on the conjunctivas)
Directly after instillation, 1 h, 24 h, 48 h, 72 h, 7 d, 15 d
Approximately 24 hours after instillation of the test substance (immediately after scoring the cornea/opacity), a solution of 2% fluorescein in water was applied to both eyes of each animal to examine quantitatively the potential for corneal injury. The brightly green staining area indicating epithelial damage was estimated as a percentage of the total corneal area. Any observed local effects were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- other: animal 1, 4, 5 and 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- other: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- other: 15 days
- Irritant / corrosive response data:
- The summarized results can be found in Table 1 and Attachment 1 in the attached background material
- Other effects:
- To calculate the mean, the scores from time points 24, 48 and 72 h after instillation of the test substance were used. The other observation points were ignored or used only to assess the reversibility of the effects.
Any other information on results incl. tables
There was no indication of a systemic effect of treatment.
Table 1. Results of eye irritation study. |
|||||
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
1 |
3 |
0 |
0 |
24 |
1 |
2 |
0 |
0 |
|
48 |
3 |
2 |
0 |
0 |
|
72 |
2 |
1 |
0 |
0 |
|
average |
2,0 |
1,7 |
0,0 |
0,0 |
|
2 |
1 |
1 |
2 |
0 |
0 |
24 |
1 |
3 |
0 |
0 |
|
48 |
3 |
3 |
1 |
0 |
|
72 |
2 |
2 |
1 |
0 |
|
average |
2,0 |
2,7 |
0,7 |
0,0 |
|
3 |
1 |
2 |
3 |
0 |
0 |
24 |
2 |
3 |
0 |
0 |
|
48 |
2 |
2 |
1 |
0 |
|
72 |
2 |
2 |
1 |
0 |
|
average |
2,0 |
2,3 |
0,7 |
0,0 |
|
4 |
1 |
2 |
3 |
0 |
0 |
24 |
3 |
2 |
0 |
0 |
|
48 |
3 |
2 |
0 |
0 |
|
72 |
2 |
2 |
0 |
0 |
|
average |
2,7 |
2,0 |
0,0 |
0,0 |
|
5 |
1 |
1 |
3 |
0 |
0 |
24 |
1 |
2 |
0 |
0 |
|
48 |
2 |
1 |
0 |
0 |
|
72 |
1 |
1 |
0 |
0 |
|
average |
1,3 |
1,3 |
0,0 |
0,0 |
|
6 |
1 |
2 |
2 |
0 |
0 |
24 |
3 |
2 |
0 |
0 |
|
48 |
3 |
3 |
0 |
0 |
|
72 |
3 |
2 |
0 |
0 |
|
average |
3,0 |
2,3 |
0,0 |
0,0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
1,50 |
2,67 |
0,00 |
0,00 |
24 |
1,83 |
2,33 |
0,00 |
0,00 |
|
48 |
2,67 |
2,17 |
0,33 |
0,00 |
|
72 |
2,00 |
1,67 |
0,33 |
0,00 |
|
24+48+ 72 |
2,17 |
2,06 |
0,22 |
0,00 |
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The study is in accordance with EPA OPP 81-4 (Acute Eye Irritation) and GLP. Under the conditions chosen, instillation of the test substance into the eyes of 6 female rabbits elicited a positive response. According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, classification for eye Irritation Category 2 (H319) is warranted.
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