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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: OECD 404 (2002) and US EPA OPPTS 870.2500 (1998); GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Remarks:
US EPA TSCA GLPs (40 CFR, Part 792); OECD GLPs

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
455-890-7
EC Name:
-
Cas Number:
6607-41-6
Molecular formula:
C26H19NO3
IUPAC Name:
455-890-7
Details on test material:
PPP-BP (CAS # 6607-41-6); 2-Phenyl, 3-3-Bis (4-Hydroxy phenyl) Phthalimidine; Purity: 99.8%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Male and female New Zealand White rabbits, at least 10 weeks of age, weighing 2.39 to 2.79 kg were obtained from Millbrook Breeding Labs, Amherst, MA. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages. They were provided food and tap water ad libitum. Room temperature was 68 +/- 5°F and the relative humidity ranged between 30-70%. Room lights were on a 12-hour light/dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
Approximately 24 hours prior to dosing, the application sites were prepared by clipping the skin of the trunk free of hair (not less than 10% of the body surface was clear for the application of the test substance). One half gram of the test substance, moistened with 1.0 mL of sterile water was applied to a small area of the skin (approximately 6 cm2).
Duration of treatment / exposure:
Each application area was covered with a gauze patch and secured with non-irritating tape. Initially, three test patches were applied sequentially to a single animal and removed after three minutes, one hour and then four hours of contact to assess for possible corrosion. Once it was determined that a four-hour exposure could humanely be allowed, a single test patch was applied to two additional animals for a four hour exposure period.
Observation period:
Dermal scores were recorded at 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs. Animals were weighed at Day 0 prior to dose administration and at the end of the observation period (Day 3).
Number of animals:
3
Details on study design:
Erythema and Edema formation were observed/scored based upon the Draize definitions:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema and Eschar Formation
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
other: Erythema and Eschar Formation
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
other: Erythema and Eschar Formation
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of erythema or edema were present at the 1 hour, 24, 48 or the 72 hour observation points in the initial test or the confirmatory test.

None of the control sites of any animal at any of the observation periods showed signs of erythema or edema.
Other effects:
All animals gained weight over the course of the study. No overt signs of toxicity were evident in any of the animals during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of this study, PPP-BP is considered to be a non-irritant.
Executive summary:

The test substance was evaluated for the potential for acute skin irritation in 3 young adult New Zealand white rabbits. A dose of 0.5 g test substance with 1.0 mL water was applied to the intact skin site under a semiocclusive dressing for 3 minutes, 1 hour and 4 hours. The application site was then washed and observations made at 1, 24, 48 and 72 hours after removal of the test substance. All organisms gained weight over the course of the study. No overt signs of toxicity were evident in any of the organisms during the course of the study. There were no signs of irritation at any time point.