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Toxicological information

Acute Toxicity: oral

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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:
Study conducted according to OECD guideline and subject to GLP audit study, tested with the source substance CAS 65997-04-8. Based on the structural similarities and the fact that the target substance is an adduct of the source substance, this study is considered valid for read-across.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Rosin, fumarated
EC Number:
266-040-8
EC Name:
Rosin, fumarated
Cas Number:
65997-04-8
Molecular formula:
Not applicable. UVCB
IUPAC Name:
Rosin, fumarated
Details on test material:
- Name of test material (as cited in study report): Rosin, fumarated
- Substance type: Chemically modifed UVCB
- Physical state: amber crystalline solid
- Analytical purity: Commercial samples
- Lot/batch No.: TWR01075-15FTOR-9.19.01
- Expiration date of the lot/batch: 21 September 2002-

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Marget, Kent, CT9 4LT
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 150-250g
- Fasting period before study: yes, overnight
- Housing: individually in suspended cages with stainless steel grid tops and solid bottoms. Analysis of bedding is presented and is not considered to contain additional substances in sufficient concentration to have any influence on the outcome of the study.
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Maintenance Diet (Special Diets Services Limited, Essex CM8 3AD, UK), ad libitum.
- Water (e.g. ad libitum): From domestic mains, ad libitum.
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 57
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: 06 August 2002 To: 29 August 2002

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: determined to be the most appropriate
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 20ml/kg

DOSAGE PREPARATION (if unusual): The required amount of test item was weighed and ground using a pestle and mortar and the requisite amount of MZO was added. Formulations were mixed by manual inversion until visibly homogeneous. The formulations were magnetically stirred and warmed prior to dosing.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 females used in total
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Viability: frequently on the day of dosing and thereafter once each day.
Clinical observations: Frequently on Day 1 and daily thereafter until Day 15.
Body weights: Immediately before dosing (Day 1) and on Days 8 and 15.
- Necropsy of survivors performed: yes on Day 15. Examination of the thoracic and abdominal organs and tissues in situ. Carcasses were discarded following this procedure.
- Other examinations performed: none
Statistics:
No formal statistical analysis was conducted.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
No treatment related clinical signs noted during observation period
Body weight:
Body weight gain was considered to have been satisfactory

Gross pathology:
No findings were noted at necropsy.
Other findings:
no data

Any other information on results incl. tables

The test item was administered orally in a single dose, by means of a gavage, followed by a 14 day observations period. The dose volume was increased from 10ml/kg to 20ml/kg after the first animal was dosed as this formulation was very difficult to get through the gavage.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 was determined to be > 2000 mg/kg in female rats.

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 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:

In an acute oral toxicity study, 5 female Sprague-Dawley rats were given a single oral dose of rosin, fumarated (CAS 65997-04-8) in maize oil at a dose of 2000 mg/kg. There were no treatment related clinical signs, necropsy findings or changes in body weight.The oral LD50 was determined to be > 2000 mg/kg in female rats.