Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 305-516-2 | CAS number: 94581-17-6
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
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study subject to GLP audit
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- 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:
- other: other: None
- 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:
- 2 010
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
- Reference substance name:
- Rosin, fumarated, reaction product with glycerol and pentaerythritol
- IUPAC Name:
- Rosin, fumarated, reaction product with glycerol and pentaerythritol
- 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
- IUPAC Name:
- Rosin, fumarated, reaction products with glycerol and pentaerythritol
- 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
Constituent 1
Constituent 2
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
