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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Wheat, ext., hydrolyzed
EC Number:
309-358-5
EC Name:
Wheat, ext., hydrolyzed
Cas Number:
100209-50-5
Molecular formula:
UVCB substance, not applicable.
IUPAC Name:
Wheat, ext., hydrolyzed
Details on test material:
Identification: Wheat Solubles, Hydrolyzed
Description: Light brown-yellow powder with lumps
Batch: Cargill WSH Batch A
Purity: treated as 100% pure
Stability under storage conditions: Stable

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Species: Rat, Wistar strain Crl:WI (Han) (outbred, SPF-Quality).

Source: Charles River Deutschland, Sulzfeld, Germany.

Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.

Age and body weight: Young adult animals (approx. 12 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.

Identification: Earmark.

Health inspection: A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health.

Conditions: Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 19.7 – 21.6ºC), a relative humidity of 30-70% (actual range: 43 - 79%) and 12 hours artificial fluorescent light and 12 hours darkness per day.

Accommodation: Group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.

Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).

Water: Free access to tap water.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Method: Oral gavage, using plastic feeding tubes.

Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.

Frequency: Single dosage, on Day 1.
Doses:
2000 mg/kg (10 mL/kg) body weight.
No. of animals per sex per dose:
Number of animals: 6 Females (nulliparous and non-pregnant). Each dose group consisted of 3 animals.
Control animals:
no
Details on study design:
The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
Statistics:
No statistical analysis was performed

Results and discussion

Preliminary study:
see below
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
Hunched posture was noted in all animals on Day 1 only. Further, piloerection was noted in one female on Day 1 and alopecia was noted in two females from Day 10 onwards.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain.
The incidence of slight body weight loss or reduced body weight gain between days 8 and 15 in individual animals was considered not indicative of toxicity, based on the absence of any corroborative findings in these animals.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
none

Any other information on results incl. tables

The oral LD50value of Wheat Solubles, Hydrolyzed in Wistar rats was established to exceed 2000 mg/kg body weight.

 

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Applicant's summary and conclusion