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EC number: 268-771-8 | CAS number: 68140-01-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Fatty acid amido propyl dimethylamines: Human health tier II Assessment
- Author:
- NICNAS
- Year:
- 2 019
- Bibliographic source:
- NICNAS Health Assessment
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Remarks:
- not specified in the publication report made by NICNAS
Test material
- Reference substance name:
- Amides, coco, N-[3-(dimethylamino)propyl]
- EC Number:
- 268-771-8
- EC Name:
- Amides, coco, N-[3-(dimethylamino)propyl]
- Cas Number:
- 68140-01-2
- IUPAC Name:
- Amines, C12-18, alkyldimethyl
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- test material in corn oil
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 29 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 120 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 60 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5 - 10 not really specified
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- In a 29-day repeated dose oral toxicity study conducted according TG 407, Sprague-Dawley rats (n=5-10/sex/dose) received Cocamidopropyl Dimethylamine in corn oil via gavage at concentrations of 0, 30, 60 or 120 mg/kg bw/day.
For the control an high dose group, half of the animals were kept for a further 4-week treatment free period for observation of reversibility, persistence or delayed occurrence of local and systemic effets.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Observed clinical signs included ptyalism, loud breathing and piloerection in some of the animals in treated groups.
- Mortality:
- no mortality observed
- Description (incidence):
- Microscopic examination
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Endocrine findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Microscopic examination revealed signs of pronounced irritation in the forestomach of animals treated with 60 or 120 mg/kg bw/day.
These consisted of acanthosis, hyperkeratosis, erosion/ulcer, oedema with mixed infiltrate of inflammatory cells in submucosa.
Changes in the forestomach were present with low severity and incidence in the low dose group. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 60 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 60 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- other: forestomach
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under tests conditions, the reported NOAEL with respect to systemic toxic effects was 60 mg/kg bw/day in rats.
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