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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
Study period:
August 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
Molecular formula:
Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.
IUPAC Name:
Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
Test material form:
solid: compact

Test animals

Species:
rat
Strain:
other: Crl.:(WI) BR - 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: m: 183 - 208 g, f: 158 - 203 g
- Fasting period before study: 16 hours
- Housing: Macrolon type III, max 5 animals
- Diet (e.g. ad libitum): ad libitum beside on day of application
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % dispersion


Doses:
Limit Test with 2000 mg/kg
No. of animals per sex per dose:
5 male + 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Records on clinical observations: approx. 20 minutes, 1, 2, 3, 6 and 24 h, thereafter once daily up to day 14.
- Frequency of body weight determination: day 0, day 7 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Preliminary study:
The preliminary study with 1 male and 1 female animal showed no mortalities at a dose of 2000 mg/kg b.w.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed.
Clinical signs:
No clinical-toxicological symptoms observed.
Body weight:
Body weight changes showed a normal weight gain.
Gross pathology:
No test compound related macroscopic findings in the cranial-, thoracic and abdominal cavity.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The toxicity after a single oral intake of the test sample is above the dose limit 2000 mg/kg bw. The substance does not need to be classified according to CLP, EU GHS (Regulation (EC) No 1272/2008) and according to DSD (Directive 67/548/EEC).
Executive summary:

In an acute oral toxicity study (limit test) performed according to the OECD Guideline 401 (Acute Oral Toxicity), groups of fasted Wistar rats (5/sex)

were given a single oral dose of Grilloten PSE 141 G in water at a dose of 2000 mg/kg bw and observed for 14 days.

Oral LD50:

Males > 2000 mg/kg bw

Females > 2000 mg/kg bw

Combined > 2000 mg/kg bw

There were no treatment related clinical signs, necropsy findings or changes in body weight.

Grilloten PSE 141 G Batch 901 is practically nontoxic based on the LD50 in males/females.