Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed per OECD Test Guideline 402 and OPPTS 870.1200 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
US EPA GLPs (40 CFR, Part 792) and OECD GLPs
Test type:
other: limit
Limit test:
yes

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
Sex:
male/female
Details on test animals or test system and environmental conditions:
Male and female New Zealand White rabbits were received from Millbrook Breeding Labs. They were 2.00-2.34 kg and at least 12 weeks of age. They were individually housed upon arrival in stainless steel suspended cages with hardwood chip bedding. The animals were acclimated for at least 5 days prior to dosing. Water and feed were provided 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.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The application sites were prepared by clipping not less than 10% of the body surface on the trunk approximately 24 hours before the application of PCP. PCP was dosed at 2000 mg/kg as received. PCP was slightly moistened and introduced under two single layer thick gauze patches and applied directly to the skin of each animal. Animals were immobilized and the patches were secured in place by wrapping the entire trunk of the animal with an impervious bandage.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
After completion of the 24-hour exposure period, the wrapping was removed and the skin was gently wiped and rinsed with water.
The animals were observed frequently during the first day and then clinical examinations were made at least once a day. The animals were also examined for signs of erythema and edema after the exposure period as per the Draize method. Animals were weighed on Days 0 (pre-dose), 7 and 14.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
other: No overt signs of clinical toxicity were observed in any animal. No signs of erythema or edema were observed in any animals.
Gross pathology:
All animals were observed as normal at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
PCP was evaluated for its potential to produce systemic toxicity or death after a single topical 24-hour application at 2000 mg/kg to the skin of rabbits. The rabbit dermal LD50 was determined to be >2000 mg/kg-bw.