Registration Dossier
Registration Dossier
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EC number: 403-240-8 | CAS number: 106264-79-3 DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- EPA 50/6-82-001
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: 3,5-dimethylthio-2,4-toluenediamine; 3,5-dimethylthio-2,6-toluenediamine
- EC Number:
- 403-240-8
- EC Name:
- A mixture of: 3,5-dimethylthio-2,4-toluenediamine; 3,5-dimethylthio-2,6-toluenediamine
- Cas Number:
- 106264-79-3
- Molecular formula:
- C9H14N2S2
- IUPAC Name:
- reaction mass of: 3,5-dimethylthio-2,4-toluenediamine 3,5-dimethylthio-2,6-toluenediamine
- Test material form:
- other: clear liquid
- Details on test material:
- purity: 95.14 % diamines
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- other: neat
- Amount / concentration applied:
- 120 mg
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 0.67
- Max. score:
- 0.16
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes fully reversible after 3 days
- Other effects:
- Severity of conjuntival erythema decreased with time: no reaction seen at 72 hours
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The substance was found to be non-irritating to rabbit eyes.
- Executive summary:
The study was performed according to OECD guideline no. 405 and EU method B.5. 0.1 ml of test article was instilled into the right eye (conjunctival sac) of each of 6 rabbits. Observations were recorded at 1, 24, 48 and 72 hrs after treatment. Scoring was conducted according to the Draize method. No iritis or corneal changes were seen in any of the animals. The substance does not have to be classified as an irritant on the basis of the test results.
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