Reaction mass of 2,2-bis(hydroxymethyl)propane-1,3-diyl bis(2-ethylhexanoate) and 3-[(2-ethylhexanoyl)oxy]-2-{[(2-ethylhexanoyl)oxy]methyl}-2-(hydroxymethyl)propyl 2-ethylhexanoate and 3-[(2-ethylhexanoyl)oxy]-2,2-bis{[(2-ethylhexanoyl)oxy]methyl}propyl 2-ethylhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance Pentaerythritol esters with 2-ethylhexanoic acid. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)

EC Number:

230-743-8

EC Name:

2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)

Cas Number:

7299-99-2

Molecular formula:

C37H68O8

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Pentaerythritol tetra(2-ethylhexanoate)
- Analytical purity: 96.4 %
- Physical state: clear, colourless liquid
- Lot/batch No.: TOL-887
- Stability under test conditions: proven by re-analysis
- Storage condition of test material: airtight at room temperature in the dark

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Japan
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: mean 201 g
- Fasting period before study: 16 h priot to dosing
- Housing: 1 - 3 animals per cage
- Diet: MF solid diet (Oriental Yeast Production (Lot No.040705, 041102), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 9-16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.5 - 24.2
- Humidity (%): 48 - 81
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations every six hours on administration day starting one hour after administration, then daily for 14 days; weighing prior to dosing and on days 7 and 154
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observed with either 300 and 2000 mg/kg bw during the observation period.

Clinical signs:

Diarrhea was observed in one animal receiving 300 mg/kg bw on the administration day.

Body weight:

Steady weight gain was observed for all animals.

Gross pathology:

No abnormalities were noted in any animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified