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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: taken from EU RAR Dibutyl Phthalate (2004)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
n/a
GLP compliance:
not specified

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

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Details on exposure:
dermal applications with 0.5, 1.0, 2.0 or 4.0 ml DBP/kg bw to the clipped intact skin
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
no data
Frequency of treatment:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
0.5, 1.0, 2.0 or 4.0 ml DBP/kg bw
Basis:
no data
No. of animals per sex per dose:
no data
Details on study design:
90-day dermal study

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data

Results and discussion

Results of examinations

Details on results:
Slight skin irritation and slight dermatitis were reported but no information was given at which dose-levels these effects were seen.
At 4.0 ml/kg bw slight renal damage was observed.

Effect levels

Dose descriptor:
NOAEL
Based on:
not specified
Sex:
not specified
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Study was not performed according to current standards, the documentation of the study was inadequate.