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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature
Justification for type of information:
Ditridecyl adipate is appropriate for read-across because it is considered as a similar substance, based on similar structure, toxicokinetic and toxicological profile useful for this interpolation (please see also read-across justification).

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
Deviations:
not specified
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Bis(tridecyl) adipate
- Physical state: clear colourless liquid
- Analytical purity: > 99%
- Lot/batch No.: J08120
- Expiration date of the lot/batch: 07 Jul 2014
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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

Key result
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.