Rosin, fumarated, reaction products with glycerol and pentaerythritol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study subject to GLP audit

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

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 (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, fumarated, reaction product with glycerol and pentaerythritol

IUPAC Name:

Rosin, fumarated, reaction product with glycerol and pentaerythritol

Constituent 2

Reference substance name:

Rosin, fumarated, reaction products with glycerol and pentaerythritol

EC Number:

296-047-1

EC Name:

Rosin, fumarated, reaction products with glycerol and pentaerythritol

Cas Number:

92202-14-7

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Ester of fumarated rosin with glycerol and pentaerythritol, consisting of mainly tri-esters, tetra-esters mixed glycerol- and pentaerythritol- esters and polyesters, as the reactor is charged with a 4:1 stoichiometric ratio of reactants (rosin/fumarated rosin with a glycerol pentaerythritol mixture), and reacted until a low ‘acid value’ is achieved, indicating that most of the –COOH groups of the parent rosin/fumarated rosin have been esterified.

Details on test material:

- Name of test material (as cited in study report): rosin fumarated reaction product with glycerol and pentaerythritol CAS 92202-14-7
- Substance type: Chemically modified UVCB
- Physical state: Solid
- Analytical purity: assumed 100%
- Lot/batch No.: 0912000188
- Expiration date of the lot/batch: March 2011
- Stability under test conditions: assumed stable
- Storage condition of test material: room temperature
- Other: Source Arizona Chemical AB

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier, 53940 Le Genest St Isle - FR
- Age at study initiation:
- Weight at study initiation:174-191 g
- Fasting period before study: overnight
- Housing: Polycarbonate cages with stainless steel mesh lids
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 deg C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 6-20 April 2010

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: standard vehicle for suspension dosing

MAXIMUM DOSE VOLUME APPLIED:10 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: substance presumed non-toxic

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

other: 3 approximately concurrent controls to determine normal body weight gain

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 0.5, 1, 3, 4 h and daily thereafter; weighed D0, D2, D7, D14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: other: None

Gross pathology:

No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Rosin, fumarated, reaction product with glycerol and pentaerythritol is greater than 2000 mg/kg bw by the oral route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item of Rosin, fumarated, reaction product with glycerol and pentaerythritol cannot be classified because it cannot be determined whether the LC50 falls in Category IV (< 2000 mg/kg) or outside of the category.

In accordance with the Globally Harmonised System (Regulation (EC) No. 1272/2008) the test item cannot be classified because it cannot be determined whether the LC50 falls in Category V (< 5000 mg/kg) or outside of the category.

Executive summary:

The acute oral toxicity of rosin, fumarated, reaction product with glycerol and pentaerythritol was evaluated in a study conducted according to OECD Guideline 423. Six female rats were each administered a single dose of 2000 mg/kg bw of the test substance by gavage. All animals survived to study termination. All animals gained weight normally and there were no signs of systemic toxicity. The acute oral LD50 in this study was >2000 mg/kg bw for female rats.