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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:
November 4 - December 2, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes (incl. certificate)
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: SAGE Labs
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 166-212 g
- Fasting period before study: overnight
- Housing: Singly in suspended stainless steel cages.
- Diet: Envigo Teklad Global 16% Protein Rodent Diet #2016, ad libitum
- Water: ad libitum
- Acclimation period: 5-16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 44-65
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: November 4, 2015 To: December 2, 2015

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30%
- Amount of vehicle (if gavage): 70%

MAXIMUM DOSE VOLUME APPLIED: 1.4 mL

DOSAGE PREPARATION: Test substance was ground and mixed with water to form a 30% (w/w) solution.
Doses:
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: Animals were observed for the first 30 minutes post dosing, and for several hours thereafter. After the first day, animals were observed daily. Body weights were assessed prior to dosing and on Day 6 or 7, and Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Preliminary study:
One animal was dosed initially. As the animal survived, another four were also dosed.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived the study.
Clinical signs:
No signs of adverse effects were noted at any observation.
Body weight:
All animals gained weight as expected during the study.
Gross pathology:
No signs of gross toxicity were noted.
Other findings:
- Histopathology: No gross abnormalities were noted.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The acute oral LD50 is > 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test substance Sucrose Palmitate Stearate MDT Grade was tested in rats. 5 female rats were exposed to a single dose of 2000 mg/kg bw of test substance by oral gavage.

All animals survived the exposure. There were no signs of adverse effects in the animals for 14 days after exposure. The acute oral LD50 is > 2000 mg/kg bw. The test substance is not toxic via the oral route.