Registration Dossier
Registration Dossier
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EC number: 807-422-1 | CAS number: 66918-01-2
Toxicological information
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: Scientific Opinion by regulatory body (EFSA)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- An assessment on the information in the Scientifc opinion by EFSA is presented in this endpoint record.
Data source
Reference
- Reference Type:
- publication (copyright not owned for reproduction)
- Title:
- Safety assessment of the substance trimellitic acid, tris (2-ethylhexyl) ester, for use in food contact materials
- Author:
- EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP),
- Year:
- 2 019
- Bibliographic source:
- EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and
Processing Aids), Silano V, Barat Baviera JM, Bolognesi C, Chesson A, Cocconcelli PS, Crebelli R, Gott DM,
Grob K, Lampi E, Mortensen A, Steffensen I-L, Tlustos C, Van Loveren H, Vernis L,
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- various study results and other data are assessed by EFSA, among others a OECD TG 414. (Renauta and Whiteley, 2017)
An assessment on the information in the Scientifc opinion by EFSA is presented in this endpoint record. - GLP compliance:
- not specified
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- not specified
- Duration of treatment / exposure:
- Trimellitic acid, tris(2-ethylhexyl) ester or DEHP was
administered to 35 mated females per group from gestational days (GD) 6–19 inclusive. On GD 20, 20
females were sacrificed, and the remaining females were treated until lactation day 20 - Frequency of treatment:
- Trimellitic acid, tris(2-ethylhexyl) ester or DEHP was
administered to 35 mated females per group from gestational days (GD) 6–19 inclusive. On GD 20, 20
females were sacrificed, and the remaining females were treated until lactation day 20 - Duration of test:
- P-females: On GD 20, 20 females were sacrificed, and the remaining females were treated until lactation day 20
Offspring: termination at 6 weeks for females and 15 weeks for males
Doses / concentrationsopen allclose all
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- Remarks:
- DEHP, equimolar to 1,050 mg of trimellitic acid, tris(2-ethylhexyl) ester
- Dose / conc.:
- 1 050 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 35
- Control animals:
- not specified
- Details on study design:
- - Dose selection rationale: not specified
- Rationale for animal assignment (if not random): not specified
- Fasting period before blood sampling for (rat) dam thyroid hormones: not specified
- Time of day for (rat) dam blood sampling: not specified
- Other: not specified
Examinations
- Maternal examinations:
- not specified
- Ovaries and uterine content:
- not specified
- Blood sampling:
- not specified
- Fetal examinations:
- not specified
- Statistics:
- not specified
- Indices:
- not specified
- Historical control data:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- 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:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- not specified/reported
Effect levels (maternal animals)
- Remarks on result:
- other: no maternal toxicity reported
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Anogenital distance of all rodent fetuses:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- The only effect reported for trimellitic acid, tris(2-
ethylhexyl) ester is retained areolar regions in male offspring of the highest dose group.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- visceral malformations
Fetal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: retained areolar region
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 1 050 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A wide range of developmental findings observed in the DEHP-treated rats were not found in rats
treated with trimellitic acid, tris(2-ethylhexyl) ester. The only effect reported for trimellitic acid, tris(2-
ethylhexyl) ester is retained areolar regions in male offspring of the highest dose group.
Due to the chemical similarity to DEHP (Di(2-ethylhexyl)phthalate, a known toxicant for reproduction and the fact, that DEHP was not identified as an analogeous substance by OECD QSAR Toolbox, the specific mode of action of phthalates is likely to cause the observed effects. Therefore, the observed effects are unlikely to be transfered to the target substance as the target substance is lacking a phthalate group.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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