Reaction Product of Rosin, fumarated, Tall-Oil Rosin, Ca(OH)2 and MgO

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: guidline study with GLP certificate

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

Ca/Mg-salt of Fumarated Tall Oil Rosin

IUPAC Name:

Ca/Mg-salt of Fumarated Tall Oil Rosin

Details on test material:

appearance : beige powder
content of the test item was not given by the sponsor
batch no. Laboransatz 1916

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 167-192 g
- Fasting period before study: yes, 16-24 hours

- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

the starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Absence or presence of compound-related mortality of the animals dosed at one step determined the next step;

Doses:

starting dose was 2000 mg/kg bw;
As no mortality occurred, dosing of 3 additional animals with the same dose

No. of animals per sex per dose:

3 females per step

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 15days )
- Frequency of observations: several times on the day of administration and at least once daily the following 14 days
and weighing:weekly undil the end of the study
- Necropsy of survivors and killed in moribund state was performed:
-Animals were examined macroscopically

Statistics:

no

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

other: applied dose

Effect level:

ca. 2 000 mg/kg bw

Remarks on result:

other: no mortality occurred in 2 independeant trials

Mortality:

at the applied dose no animal died

Clinical signs:

other: No clinical signs were observed

Gross pathology:

the necropsies performed at the end of the study revealed no particular findings

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

According to OECD guideline 423 the LD50 cut-off of Ca-/Mg-salt of Fumarated Tall Oil Rosin is > 5000 mg/kg bw

Executive summary:

According to OECD TG 423 3 female Wistar rats were given 2000 mg/kg bw and observed for 14 further days. No mortality occurred and no clinical signs or effects on weight gain were observed . Therefore the test was repeated with further 3 female Wistar rats. Again the dose of 2000 mg/kg bw was tolerated by female rats without mortalities and effects on weight gain and gross pathological findings. Thus, the LD50 cut-off of Ca-/Mg-salt of Fumarated Tall Oil Rosin is > 5000 mg/kg bw.(Bayer Pharma AG 2011)