Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)

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:

No data available, ECHA provided study summaries migrated from the SNIF format.

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex V

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

415-650-4

EC Name:

-

Cas Number:

153965-54-9

Molecular formula:

not applicable (multi-constituent)

IUPAC Name:

3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(2-ethylhexanoyl)oxy]methyl})propyl 2-ethylhexanoate; 3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(2-ethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate; 3-[(2-ethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate; 3-[(2-ethylhexanoyl)oxy]-2-{[(2-ethylhexanoyl)oxy]methyl}-2-{[(3,5,5-trimethylhexanoyl)oxy]methyl}propyl 3,5,5-trimethylhexanoate; 3-[(3,5,5-trimethylhexanoyl)oxy]-2,2-bis({[(3,5,5-trimethylhexanoyl)oxy]methyl})propyl 3,5,5-trimethylhexanoate

Test material form:

other: No data available, ECHA provided study summaries migrated from the SNIF format.

Details on test material:

No data available, ECHA provided study summaries migrated from the SNIF format.

Test animals

Species:

other: Rat (Sprague-Dawley)

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: arachis oil B.P.

Details on oral exposure:

Method of administration:
gavage

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 400 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 400 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:

Clinical observations:
Mortality data:


There were no deaths during the study.


Clinical observations:


No clinically observable signs of toxicity were detected in
test or control animals throughout the study period.


Bodyweight:


All test animals showed normal gains in bodyweight
throughout the study period, comparable with control.


Food consumption:


There were no adverse effects on food consumption during the
study. Food efficiency in test animals was comparable with
that seen in controls.


Water consumption:


Visual inspection of water bottles revealed no overt
intergroup differences.

Laboratory findings:
Haematology:


There were no treatment-related changes in the
haematological parameters measured.


Blood chemistry:


There were no blood chemical changes which could be
considered toxicologically significant.

A statistically significant increase (30%) in high dose
female inorganic phosphate was detected in comparison with
controls. The change in isolation was considered to be of no
toxicological significance. Statistically significant
increases in low and high dose female aspartate
aminotrasferase (up to 14%) and intermediate and high dose
female alanine aminotransferase (up to 26%) were detected
but no convincing dose relationship was apparent and all
values were within normally accepted ranges.

Effects in organs:
Necropsy:


High dose animals of both sexes showed slight pallor of the
liver at necropsy. Two females showed a more pronounced
pallor and these individuals, plus two males, also showed
accentuated lobular pattern. High dose males also showed
speckled kidneys, however, this macroscopic abnormality was
not apparent in the females from this dose group.

No treatment-related macroscopic changes were detected in
the other dose groups.

Organ weights:


A slight but statistically significant increase (9%) in
relative kidney weight was detected for high dose males in
comparison with controls. All values were within the
normally expected range for rats of this strain and age,
but, in view of the macroscopic and microscopic changes
identified in these animals, the increase was considered to
be toxicologically significant.

No other significant changes were noted.


Histopathology:


Kidneys; Degeneration and necrosis of renal proximal tubules
were observed for male rats dosed at 150, 400 and
1000mg/kg/day. A similar effect was not observed for female
rats.

No other toxicologically significant changes were observed.

Effect levels

Remarks on result:

other: No data available, ECHA provided study summaries migrated from the SNIF format.

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Classified as: Xn - harmful