Registration Dossier
Registration Dossier
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EC number: 201-557-4 | CAS number: 84-74-2
Repeated dose toxicity: dermal
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:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- n/a
- GLP compliance:
- not specified
Test material
- 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
Constituent 1
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.
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