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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:
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:
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:
guideline study
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose:
read-across source
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed
Clinical signs:
No clinical signs related to the administration of the test substance were observed
Body weight:
The body weight gain was lower 48 hours post-dose in the treated group (10g versus 25g in the historical control group). Thereafter the bodyweight gain was normal.
Gross pathology:
The macroscopic examination revealed no treatment-related changes.
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:

This data is being read across from the source study that tested Resin acids and rosin acids, calcium zinc salts based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

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.

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
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
No clinical signs related to the administration of the test substance were observed
Body weight:
The body weight gain was lower 48 hours post-dose in the treated group (10g versus 25g in the historical control group). Thereafter the bodyweight gain was normal.
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.