Registration Dossier
Registration Dossier
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EC number: 208-046-5 | CAS number: 506-59-2
Eye irritation
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- Dimethylamine
- EC Number:
- 204-697-4
- EC Name:
- Dimethylamine
- Cas Number:
- 124-40-3
- IUPAC Name:
- N-methylmethanamine
- Details on test material:
- Dimethylamin, 40%-ige waessrige Loesung
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.17 kg (mean)
- Diet (e.g. ad libitum): SNIFF
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye served as untreated control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100µl - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h - 72 h
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Time point:
- other: 24 h - 48 h - 72 h
- Remarks on result:
- other: reading not possible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h - 48 h- 72 h
- Max. score:
- 4
- Reversibility:
- not reversible
Any other information on results incl. tables
No further details available.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information irritating to the eyes, H319: Causes serious eye irritation Criteria used for interpretation of results: EU
- Conclusions:
- Classification: risk of serious damage to eyes
- Executive summary:
The test substance DMA was irritating to rabbit eyes (Draize-test). Hence, Dimethylamine hydrochloride (CAS-No. 506-59-2, EC-No. 208-046-5), which is a near analogue to Dimethylamine (CAS-No. 124-40-3, EC-No. 204-697-4) should be also irritating (classification according to EU criteria: Cat. 2, H319)
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