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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb 1998- Mar 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
Version / remarks:
Directive 67/548
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
444-000-2
EC Name:
-
Cas Number:
647028-25-9
Molecular formula:
This is a UVCB so NA
IUPAC Name:
3-[3-(pentanoyloxy)-2,2-bis[(pentanoyloxy)methyl]propoxy]-2,2-bis[(pentanoyloxy)methyl]propyl pentanoate 3-{3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propoxy}-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: straw coloured liquid
- Analytical purity: UVCB tested
- Storage condition of test material: at room temperature in darkness

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
Substance tested as supplied.
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
150 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5 male animals and 5 female animals per dose
Control animals:
yes

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Laboratory findings:
Haematology/Blood Chemistry: No treatment-related changes in the haematological parameters measured. There were no
treatment-related changes detected in the blood chemical; parameters measured.

Effects in organs:
There were no treatment-related changes detected in the organ weights measured. Males treated with 500 mg/kg/day
showed a statistically significant reduction in absolute epididymides weight when compared with controls but, in the absence of a convincing dose-response relationship, this finding was considered to be incidental and of no toxicological significance.

There were no treatment-related macroscopic abnormalities detected at terminal kill.

Treatment-related kidney changes were observed. Three males treated with 1000 mg/kg/day demonstrated globular accumulations of eosinophilic material in the proximal tubular epithelium which should be regarded as a possible effect of treatment. This finding is consistent with the appearance of hydrocarbon nephropathy and is not considered to represent a hazard to human health.
No such effect was observed among 500 or 150 mg/kg/day animals.
Mortality:
no mortality observed
Haematological findings:
no effects observed
Organ weight findings including organ / body weight ratios:
effects observed, non-treatment-related
Description (incidence and severity):
There were no treatment-related changes detected in the organ weights measured. Males treated with 500 mg/kg/day showed a statistically significant reduction in absolute epididymides weight when compared with controls but, in the absence of a convincing dose-response relationship, this finding was considered to be incidental and of no toxicological significance.
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Description (incidence and severity):
Three males treated with 1000 mg/kg/day demonstrated globular accumulations of eosinophilic material in the proximal tubular epithelium which should be regarded as a possible effect of treatment. This finding is consistent with the appearance of hydrocarbon nephropathy and is not considered to represent a hazard to human health. No such effect was observed among 500 or 150 mg/kg/day animals.
Details on results:
There were no treatment-related macroscopic abnormalities detected at terminal kill.

Effect levels

open allclose all
Key result
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day
Key result
Dose descriptor:
NOEL
Effect level:
500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified

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