Resin acids and Rosin acids, manganese salts

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:

guideline study

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

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

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, calcium zinc salts

EC Number:

269-825-3

EC Name:

Resin acids and Rosin acids, calcium zinc salts

Cas Number:

68334-35-0

Molecular formula:

calcium zink (1R,4aR,4bR,10aR)-1,4a-dimethyl-7- propan-2-yl-2,3,4,4b,5,6,10,10a-octahydrophenanthrene-1- carboxylate

IUPAC Name:

calcium, zinc (1R,4aR,4bR,10aR)-1,4a-dimethyl-7-propan-2-yl-2,3,4,4b,5,6,10,10a-octahydrophenanthrene-1-carboxylate

Constituent 2

Reference substance name:

Resin acids and rosin acids, calcium, zinc salts

IUPAC Name:

Resin acids and rosin acids, calcium, zinc salts

Details on test material:

Source: Flint Group, Germany. Batch No GZ 20-015Z. Form: yellow powder.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Source of animals: Elevage JANVIER, France
Age at receipt: 8 weeks
Weight at dosing: 187 to 207g
Acclimatization period: 5 days
Housing: Groups of three in solid bottomed clear polycarbonate cages with SS mesh lid and sawdust bedding
Diet: SDS M20 ad libitum
Water: tap water from public supply

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

2g of the test item was weighed and olive oil was added in a 10mL volumetric flask. The preparation was magnetically ystirred to obtain an homogenous suspension.

Doses:

The animals were dosed with 2000 mg/kg bw in a volume of 10 mL/kg bw using a graduated syringe fitted with a metal canula.

No. of animals per sex per dose:

Two groups of three females were dosed with 2000 mg/kg bw on each of two days, three animals in step 1 and three animals in step 2 one day later.

Control animals:

no

Details on study design:

Animals were observed on day 1 at 30, 60 180 and 240 minutes after dosing. Thereafter, they were observed on day 2, 7 and 14. At the end of the study all animals were euthanised and examined for macroscopic lesions; any macroscopic lesions were removed and preserved for microscopic examination.

Statistics:

None

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed

Clinical signs:

other: No clinical signs related to the administration of the test substance were observed

Gross pathology:

The macroscopic examination revealed no treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD50 of Resin acids and rosin acids, calcium, zinc salts CAS No. 68334-35-0 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 Resin acids and rosin acids, calcium, zinc salts CAS No. 68334-35-0 should not be classified. No symbol and risk phrase are required.

In accordance with the Globally Harmonised System (Regulation (EC) No. 1272/2008) the test item should not be classified. No signal word or harmonised statement are required.

Executive summary:

The test item, Resin acids and rosin acids, calcium, zinc salts CAS No. 68334-35-0, was administered to six female rats at a dose level of 2000 mg/kg bw after formulation in olive oil. At all the observation points up to the termination of the study on day 14, no mortalities, clinical signs or macroscopic abnormalities were observed. The oral LD50 of the test item was greater than the limit dose of 2000 mg/kg bw.