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Toxicological information

Repeated dose toxicity: oral

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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:
2012
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

Constituent 1
Chemical structure
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
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.