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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 based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

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
Details on test material:
Source: Flint Group, Germany. Batch No GZ 20-009Z. 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: 186 to 204g
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:
approximate LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal was found dead at 23h 50 min post-dose. A white coloration associated with red spots was noted on the stomach corpus. No clinical or gross anatomical signs of gavage injury were present. Consequently the death was attributed to the test substance.
Clinical signs:
No clinical signs related to the administration of the test substance were observed, except for the single death described above.
Body weight:
The body weight gain was lower 48 hours post-dose in the treated group (9g versus 25g in the historical control group). Thereafter the bodyweight gain was normal.
Gross pathology:
The macroscopic examination revealed a white thinning of the forestomach.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Resin acids and rosin acids, magnesium salts CAS No. 68440-56-2 is greater than 2000 mg/kg bw by the oral route in the rat. In accordance with the OECDguideline No. 423, the LD50 cut-off for the test item may be considered to be greater than 2500 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.