Registration Dossier
Registration Dossier
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EC number: 939-783-7 | CAS number: -
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Bis(tridecyl) adipate
- EC Number:
- 241-029-0
- EC Name:
- Bis(tridecyl) adipate
- Cas Number:
- 16958-92-2
- IUPAC Name:
- ditridecyl adipate
- Details on test material:
- - Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 6.5 - 7 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Application on the clipped dorsal skin
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 800, and 2000 mg/kg bw
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Rationale for selecting satellite groups: radiotracer study to determine extent of dermal absorption
Examinations
- Observations and examinations performed and frequency:
- Toxicity was assessed by mortality, clinical observations, body weight measurements,
organ weight, serum chemistry, hematology, necropsy, gross and histopathology, sperm
morphology. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- radiotracer study to determine extent of dermal absorption using C14 radiolabelled test substance
- Statistics:
- Dunnett¿s test, Duncan¿s Multiple Range test, chi-square distribution
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- minimal effects on skin
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Only slight erythema (redness) and flaking of the skin was observed as consequence of dermal application of test substance.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Results from the radiotracer study indicated that the test substance showed relatively low dermal absorption (only 10% of the radiolabelled dose absorbed)
Applicant's summary and conclusion
- Conclusions:
- No systemic toxicity was observed in this 13 week repeated dose toxicity study after dermal administration of test substance doses up to 2000 mg/kg bw.
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