Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: taken from EU RAR

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
n/a

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl phthalate
EC Number:
201-557-4
EC Name:
Dibutyl phthalate
Cas Number:
84-74-2
Molecular formula:
C16H22O4
IUPAC Name:
dibutyl phthalate
Test material form:
not specified
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male

Administration / exposure

Type of coverage:
other: covered
Vehicle:
ethanol
Duration of exposure:
no data
Doses:
43.7 mg/kg bw
No. of animals per group:
no data
Control animals:
no
Details on study design:
A dermal application under covered condition (plastic cap) of 43.7 mg/kg bw (157 µmol/kg bw)
14C-DBP in ethanol to the clipped skin (circular area with diameter of 1.3 cm) of male F344 rats
(bw 180-220 g)

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Absorption in different matrices:
10-12% of the administered dose per day was excreted in urine for a total of ca. 60% within 7 days. In feces ca.1% of the dose was excreted
in 24 hours (totally ca. 12% within 7 days)

Applicant's summary and conclusion