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EC number: 302-446-4 | CAS number: 94109-09-8
Toxicological information
Repeated dose toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- EC Number:
- 222-020-0
- EC Name:
- Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Cas Number:
- 3319-31-1
- Molecular formula:
- C33H54O6
- IUPAC Name:
- tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot P13
- Expiration date of the lot/batch: unknown
- Purity test date: unknown
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature
- Stability under test conditions: satble
- Solubility and stability of the test substance in the solvent/vehicle: no vehicle
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- 10 M / 10 F
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 90 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 225 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 M / 10 F
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- No signs of toxicity; no effect on feed consumption or body weight gains; dose-related statistically significant increase in absolute liver weights in high dose females, and a statistically significant increase in relative liver weights in high dose males and females; absolute and relative spleen weights were decreased in high dose males; some microscopic lesions in the liver and spleen were observed; no significant effect on the estrous or spermatogenic cycles; absolute and relative liver weights were slightly increased in females, but not males, at the end of recovery; no other significant changes were observed at the end of treatment or recovery periods
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- dose-related statistically significant increase in absolute liverweights in high dose females, and a statistically significant increase inrelative liver weights in high dose males and females; absolute andrelative spleen weights were decreased in high dose males; some microscopic lesions in the liver and spleen were observed;
absolute and relative liver weights were slightly increased in females, but not males, at the end of recovery; - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 225 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- clinical signs
- organ weights and organ / body weight ratios
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- clinical signs
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 225 mg/kg bw/day and LOAEL = 1000 mg/kg bw/day
Triethylhexyl Trimellilate is not toxic by oral route.
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