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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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: Patch Test for Primary Skin Irritation and Corrosivity (Code of Federal Regulations, Title 16, Chapter II, 1976) and Section 173.240 of the department of Transportation Hazardous Materials Regulations ( Federal Register, Monday, September 27, 1976)
Principles of method if other than guideline:
.
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

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml undiluted
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
Six
Details on study design:
0.5 ml of undiluted test material was applied under a one inch square surgical gauze patch to an intact and abraded skin on both the back and abdomen of 6 New Zealand White rabbits. Each patch was held in place by 2 one inch strips of adhesive tape. After application of the patches, the trunk of each rabbit was wrapped with rubber dental damming which was secured with staples. After 24 hours, the patches were removed and any residual material was removed. The reactions were scored immediately after the removal of the patches (24-hour reading) and again 48 hours later (72-hour reading).

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
> 0.04 - <= 0.09
Max. score:
8
Reversibility:
no data
Irritant / corrosive response data:
Following dorsal application, irritative effects noted at the 24-hour reading included very slight erythema at one intact and one abraded site. The Primary Irritation Index (PII) was found to be 0.09. Following ventral application, no irritative effects were noted at the 24-hour reading. However, at the 72-hour reading, very slight erythema was noted at one abraded site. No other irritative effects were noted at any time throughout the study. The Primary Irritation Index (PII) was found to be 0.04.

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 skin in this assay.