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)

Acute Toxicity: oral

Administrative data

Endpoint:

acute 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, B1

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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

Vehicle:

other: None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: No signs of systemic toxicity were noted during the study period. All animals showed gains in bodyweight over the study period.

Gross pathology:

Effects on organs:
No abnormalities were noted at necropsy of animals killed at
the end of the study period.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

According to Regulation (EC) No. 1272/2008 and its amendments.

Conclusions:

In an acute oral toxicity study with male and female rats, performed according to EU Method B.1 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.

Executive summary:

RB68 was tested in an acute oral toxicity study with male and female rats, performed according to EU Method B.1 test guideline and GLP principles.

No mortality occurred. No signs of systemic toxicity were noted during the study period. All animals showed gains in bodyweight over the study period.

No abnormalities were found at macroscopic post mortem examination of the animals. Based on the results, an LD50 >2000 mg/kg bw was determined. RB68 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (including all amendments).