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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Study conducted per OECD Test Guideline 404 and EPA OPPTS 870.2500 following GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

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 40 CFR, Part 792 and OCED GLPs, 1996

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(α,α-dimethylbenzyl)phenol
EC Number:
209-968-0
EC Name:
4-(α,α-dimethylbenzyl)phenol
Cas Number:
599-64-4
Molecular formula:
C15H16O
IUPAC Name:
4-(2-phenylpropan-2-yl)phenol
Details on test material:
p-Cumylphenol (PCP, CAS #599-64-4), Purity = 99%;

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 2.15 to 2.21 kg were obtained from Millbrook Breeding Labs. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages with hardwood chip bedding. They were provided rabbit diet and tap water ad libitum. Room temperature was 68+/-5 degrees 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:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Three rabbits were dosed with 0.5 g of PCP on a small area, approximately 6 cm², of skin on the shaved trunk. A gauze patch was placed over the area and secured with non-irritating tape.
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. Daily clinical observations included all toxicologic and pharmacologic signs.
Number of animals:
Three

Results and discussion

In vivo

Results
Irritation parameter:
other: erythema and edmea score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
8
Remarks on result:
other: No erythema or edema observed
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 classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, PCP is considered to be a non-irritant.