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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study available
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well-documented GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: C-01650 (4-HAP)
purity: 99.97%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Body weight: 2.0 - 4.0 kg at time of dosing
Acclimatization period: 7 days
Animal identification: Each animal was assigned an unique and individual number. This number was permanently indicated on the anizial with an ear tag.
Animals were housed separately from any other species. They were individually housed in stainlese steel, wire mesh bottom cages.
Temperature: 63 - 73°F; humidity: 30 - 70%
Day/night rhythm: 12 h dark, 12 h light
Fresh certified rabbit feed and fresh potable water were offered ad libitum.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
Six rabbits received 0.5 g of solid test substance on the intact skin site. The test substance was sufficiently moistened with sterile water to ensure good contact with the skin. One adjacent, untreated skin site (intact) was used as a negative control on each animal. Each site was approximately one square inch in size. Each site was exposed approximately 4 hours.
Observations for skin irritation were made at prescreen within 60 minutes after compound removal (approximately 4 hours), 24 hours, 48 hours and 72 hours following patch removal.
Animal body weights were taken within 48 hours of receipt, at the end of quarantine and prior to dosing.
All animals were sacrificed following the 72 hour scoring period.
Evaluation was done using the Draize scoring system (Draize, S.H., 1959).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h - 72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h - 72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

At pre-screen all animals were free of dermal irritation.

All of the control sites were free of dermal irritation throughout the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information