Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1982 and 1984 EPA TSCA Health Effects Test Guidelines (EPA Report 560/6-84-002 and 560/6-82-001). GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 1982 and 1984 EPA TSCA Health Effects Test Guidelines (EPA Report 560/6-84-002 and 560/6-82-001)
GLP compliance:
yes
Remarks:
TSCA GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Biphenol Dianhydride (BPA-DA); from GE Company; Purity: >99%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Male and female New Zealand White rabbits, approximately 12 to 18 weeks of age, weighing 2.0 to 3.0 kg were obtained from Hazleton-Dutchland, Inc. The animals were acclimated for at least five days and individually housed in cages with wire floors. They were maintained on rabbit diet and provided water (municipal) ad libitum. Room temperature ranged from 67 degrees F to 70 degrees F and the relative humidity ranged between 48-56%. Room lights were on a 12-hour cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Six rabbits were dosed with 0.5 g of test material moistened with distilled water on the shaved dorsal area of the trunk. A one-inch square gauze patch was placed over the dose site and secured with adhesive tape. Plastic sheeting was secured loosely around the trunk of each animal.
Duration of treatment / exposure:
The exposure time was four hours.
Observation period:
Dermal scores were recorded at 1, 24, 48 and 72 hours after the end of the contact period.
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Score:
ca. 0
Remarks on result:
other: No erythema or edema was observed for any animal at any timepoint.
Irritant / corrosive response data:
No erythema/edema was observed for any animal at any time period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, BPA-DA is considered to be a non-irritant.