Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 1 to 21, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EG-guideline 84/449/EEC
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc diricinoleate
EC Number:
235-911-4
EC Name:
Zinc diricinoleate
Cas Number:
13040-19-2
Molecular formula:
C18H34O3.1/2Zn
IUPAC Name:
zinc bis(12-hydroxyoctadec-9-enoate)
Constituent 2
Reference substance name:
9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
IUPAC Name:
9-Octadecenoic acid, 12-hydroxy-, zinc salt (2:1)
Constituent 3
Reference substance name:
Zinc ricinoleate
IUPAC Name:
Zinc ricinoleate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga, D-8714 Sulzfeld
- Age at study initiation: -
- Weight at study initiation: male 250 - 269 g, female 169 -222 g
- Fasting period before study: 16 h
- Housing: Macrolon cage type III
- Diet (e.g. ad libitum): Sniff, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20° +- 2°C
- Humidity (%): 50 - 80 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From: To:-

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
The test substance was applied as 20 % dispersion in aqua deion. by single application with a stomach tube.
Doses:
1: 2000 mg/kg bw.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 20', 1+2+3+6+24 hours, daily up to day 14; weighing: day 0 + day 7 + day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No

Results and discussion

Preliminary study:
Range finding: 2 female rats dosed with 2000 mg/kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
no clinical toxicological signs
Body weight:
normal weight gain
Gross pathology:
no findings
Other findings:
No

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
GRILLOCIN PY 88 is practically nontoxic after single oral application.
Executive summary:

The test substance is a fine white powder. It was tested regarding its acute toxic potential following single oral application according to the OECD guideline No. 401 in a limit test with a dose of 2000 mg/kg body weight. The test substance was applied as 20 % dispersion in water by gavage to 5 male and 5 female rats. No symptoms of toxicity were observed, no death occured during the 14 day observation period. Body weight gain was in the normal range and necropsy revealed no visible compound related macroscopic findings.

The LD50 -value for acute oral toxicity is > 2000 mg/kg body weight.