Registration Dossier
Registration Dossier
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EC number: 203-825-6 | CAS number: 111-01-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 2014
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 2,6,10,15,19,23-hexamethyltetracosane
- EC Number:
- 203-825-6
- EC Name:
- 2,6,10,15,19,23-hexamethyltetracosane
- Cas Number:
- 111-01-3
- Molecular formula:
- C30H62
- IUPAC Name:
- 2,6,10,15,19,23-hexamethyltetracosane
- Test material form:
- other: liquid
- Details on test material:
- Synthetic squalane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar Hannover RccHan®:WIST rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The females were nulliparous and nonpregnant
Cage card and individual ear tattoo
Acclimatization: 7 days (males) and 6 days (females) between arrival and treatment start
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Males: two weeks prior to mating and at least up to and including the day before sacrifice (minimum of 28 days).
Females: two weeks prior to mating and at least up to and including the day before sacrifice (day 4 postpartum). - Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Group 1
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- Group 2
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- Group 3
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- Group 4
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Sacrifice and pathology:
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Other examinations:
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Statistics:
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Mortality:
- no mortality observed
- Description (incidence):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Neuropathological findings:
- not specified
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Other effects:
- not specified
- Description (incidence and severity):
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
- Details on results:
- Kindly refer to General toxicity of Parental (F0) and litter (F1) generation in reprotoxicity OECD 422 study record
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 10 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- food efficiency
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- urinalysis
- water consumption and compound intake
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- For F0 generation:
Males:
The dose of 1000 mg/kg can be considered the NOAEL (No Observed Adverse Effect Level) for systemic toxicity.
The dose of 1000 mg/kg can be considered the NOEL (No Observed Effect Level) for fertility and mating performance.
Females:
The dose of 1000 mg/kg can be considered the NOAEL for systemic toxicity.
The dose of 1000 mg/kg can be considered the NOAEL for fertility and mating performance and 100mg/kg for breeding.
For F1 generation: The dose of 1000 mg/kg can be considered the NOEL. - Executive summary:
The study was designed to investigate the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and is compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test” (adopted 22 March 1996).
The test item Phytosqualan was administered orally (by gavage) to three groups, each consisting of ten male and ten female RccHan®:WIST rats, daily for at least 4 weeks (including two weeks prior to mating, through mating, pregnancy and early lactation for females) at the following dose levels: 0, 100,300 and 1000 mg/kg/day.
No mortality was recorded in any sex. No test-item-related differences from the control group were recorded in males. No test item-related alterations were recorded.
The systemic toxicity NOAEL was 1000 mg/kg/day for male and female (F0 and F1 generation)
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