Registration Dossier
Registration Dossier
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EC number: 283-381-8 | CAS number: 84604-96-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01st Oct 2012 to 11th Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted april 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- EC Number:
- 283-381-8
- EC Name:
- Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc
- Cas Number:
- 84604-96-6
- Molecular formula:
- C38H76N2S4Zn
- IUPAC Name:
- bis({[bis(3,5,5-trimethylhexyl)carbamothioyl]sulfanyl})zinc
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch no 165021120039.2
Expiry:10 July 2014
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Labs
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.71 or 2.84 kg
- Housing: individually and suspended in cages
- Diet (e.g. ad libitum): 2930c tekland global certified rabbit diet
- Water (e.g. ad libitum): free access to mains water
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%):30-70
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light):12 hours light ( 6.00 to 18:00) then 12 hours darkness
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Vehicle controls validity:
- not valid
- Negative controls validity:
- not valid
- Positive controls validity:
- not valid
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other:
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 0
- Reversibility:
- other:
- Irritant / corrosive response data:
- no corneal or iridial effects were noted during the study- please see attached results in table 1.
minimal conjuctival irritation was noted in both treated eyes one and 24 hours after treatement and persisted in one treated eye at the 48 hour observation, however all signs of redness, chemosis was not present at the 72 hour observation stage. No irreversible effects.
Kay and Calandra classifcation system was used and documented in report, concluding the test item produced a maximum group mean score of 6.0 and was classified as mild irritant ( class4 on a 1-8 scale) to rabbit eye
Group mean score was 6.0 at one hour post treatment, at 24 hours, the groupd mean had reduced to 4.0 and at 48 hours to 1.0 then 0.0 at 72 hours. Individual scores for
Both animals showed expected gain in body weight during the study
Any other information on results incl. tables
The pH of the test item was determined prior to commencement of the study and found to be 9.3 after 10 mins preparation.
Initial pain reaction for both animals was IPR of 2 ( slight initial pain)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Test item produced weak irritation as judged by modified Kay and Calandra system. Hoever comparison to CLP criteria does not warrant any Irritant classification
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