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Toxicological information

Eye irritation

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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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Acute Eye Irritation (Code of Federal Regulations, Title 16, Chapter II, 1976)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.