Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids

Repeated dose toxicity: oral

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

Test material information

Constituent 1

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 / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

150 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

500 mg/kg bw/day (nominal)

Doses / concentrations 4

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

1

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

2

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