Registration Dossier

Diss Factsheets

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

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 levelsopen allclose all
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 5 000 mg/kg bw
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:
No clinical signs were observed
Body weight:
There were no toxicollogically significant effects on body weight or body weight gain
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)