Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.

Data source

Reference
Reference Type:
other: TSCA 8e submission
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Benzyltrimethyl Ammonium Chloride (60% solution in water). Lot No. 59.

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
Albino rabbits were used. No further details provided

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 ml was applied to the skin
Duration of treatment / exposure:
24 hours
Observation period:
animals were observed at 24 and 72 hours
Number of animals:
6
Details on study design:
The test procedure was modeled after that of Draize et al.

Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit. Two test sites located lateral to the midline of the back approximately ten centimeters apart were selected. One of the two sites was abraded by making four epidermal incisions, two perpendicular to the other two, while the other test site remained intact.

The test material was applied to each of the test sites on each rabbit and occluded with gauze patches which were secured with masking tape. The trunk of each animal was then wrapped with impervious plastic sheeting. The wrap held the patches in position and retarded evaporation of the test material during the 24-hour exposure period.

At the end of 24 hours, the plastic wrappings. patches, and all residual test material were removed. The intact and abraded test sites were examined
and scored separately for erythema and edema on a graded scale of 0 to 4. After 72 hours, the sites were again examined and scored.


Reference:
Draize. John H., Woodard. Geoffrey, and Calvery. Herbert 0., Methods for the Study of Irritation and Toxicity of Substances .Applied Topically to
the Skin and Mucous Membranes. J. Pharm. & Exp. Ther. 82:377 (1944).

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.7
Max. score:
1
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin was fully reversible within 72 hours
Irritant / corrosive response data:
Erythema was observed on intact and abraded skin 24 hours after application of test material. No evidence of edema was noted.
Other effects:
No additional information available

Any other information on results incl. tables

Table 1 Dermal Effects following Dermal Exposure to Benzyltrimethylammonium chloride

            Irritation Scores for Abraded Skin Sites:      Irritation Scores for Intact Skin Sites at:     
      24 hours     72 hours     24 hours     72 hours
 Animal Number  Erythema  Edema  Erythema  Edema  Erythema  Edema  Erythema  Edema
 1  1  0  1  0  1  0  0  0
 2  1  0  1  0  1  0  0  0
 3  1  0  0  0  1  0  0  0
 4  1  0  1  0  1  0  0  0
 5  1  0  1  0  1  0  0  0
 6  1  0  0  0  1  0  0  0
 Mean  1.0  0.0  0.7  0.0  1.0  0.0  0.0  0.0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Slight dermal irritation,erythema, was observed on intact and abraded skin. While total recovery was noted on intact skin within 72 hours, some erythema was still observed after 72 hours on abraded skin. There was no evidence of edema.
Executive summary:

The dermal irritation potential of the test material was examined. Slight dermal irritation,erythema, was observed on intact and abraded skin. While total recovery was noted on intact skin within 72 hours, some erythema was still observed after 72 hours on abraded skin. There was no evidence of edema.