Registration Dossier
Registration Dossier
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EC number: 256-181-3 | CAS number: 45021-77-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Acute Eye Irritation (Code of Federal Regulations, Title 16, Chapter II, 1976)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Diallyldimethylammonium chloride
- EC Number:
- 230-993-8
- EC Name:
- Diallyldimethylammonium chloride
- Cas Number:
- 7398-69-8
- IUPAC Name:
- N-allyl-N,N-dimethylprop-2-en-1-aminium chloride
- Details on test material:
- - Name of test material (as cited in study report): CC-47 DADMAC monomer
- Molecular formula (if other than submission substance): C8H16N.Cl
- Molecular weight (if other than submission substance): 161.68
- Smiles notation (if other than submission substance): C(=C)CN{+}(c)(c)(.Cl{-})CC=C
- InChl (if other than submission substance): 1/C8H16N.ClH/c1-5-7-9(3,4)8-6-2;/h5-6H,1-2,7-8H2,3-4H3;1H/q+1;/p-1
- Substance type: organic
- Physical state: pale yellow liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1ml undiluted
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 24h, 48h and 72h
- Number of animals or in vitro replicates:
- six
- Details on study design:
- SCORING SYSTEM: Method of Draize
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 20
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Not irritating
- Irritant / corrosive response data:
- Irritative effects noted at the 24-hour reading following application included slight to moderate conjuctival erythema and slight conjuctival discharge in 3 rabbits. At the 48-hour reading slight to moderate conjuctival erythema was noted in 3 rabbits. At the 72-hour reading slight conjuctival erythema was noted in 1 rabbit. No corneal opacity or iritis was noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DADMAC was determined to be not irritating to eyes in this assay.
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