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Toxicological information

Acute Toxicity: oral

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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
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study subject to GLP audit
Reason / purpose:
read-across source
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Gain normal
Gross pathology:
No abnormalities detected
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:

This data is being read across from the source study that tested Rosin, fumarated, reaction products with glycerol and pentaerythritol based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

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. 

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
None
Body weight:
Gain normal
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.