Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16-31 July 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to OECD 423

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: pastilles
Details on test material:
Test Item SABOSTAT A 300
Lot Number 20085596
CAS No Not applicable
Certificate Test Item Specification Sheet of LAUS GmbH
Manufacturer SABO S.p.A.
Appearance Whitish pastilles
Composition
Reaction product of stearyl-diethanol-amine with C16-C18
saturated fatty acids
Expiry Date 10. April 2016
Storage Room temperature (20 ± 5 °C), keep away from light/humidity

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Test Animals
Species Wistar rats
Source Velaz Prague, Czech Republic
Number and Sex of Animals 6 females
Age at First Dose
At least 8-12 weeks; female animals were non-pregnant and
nulliparous
Animal Health The health condition of animals was examined by a veterinarian before
initiation of the study.
Acclimatisation The animals were acclimated under the conditions identical to the
conditions during the experiment 5 days prior to the start of treatment.
The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel
racks, up to 3 animals per cage in a room equipped with central airconditioning.
The room temperature was maintained within the range
of 22 ± 2° C, relative humidity within 55 ± 10 %. The light regimen
was set to a 12-hour light /12-hour dark cycle. The sanitation was performed according to the standard operation procedures
Diet A laboratory food Altromin (Altromin Spezialfutter GmbH, Germany)
was offered in recommended doses each day approximately at the
same time. The certificate of analysis is included in the raw data.
Water The animals received tap water for human consumption. Supply of
drinking was unlimited. The quality of drinking water is periodical
analysed (including microbiological control) and recorded; certificate
of analysis is included in raw data.
Bedding Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification Each animal was marked with an ID number. Each cage was affixed
with a cage card containing pertinent animal and study information.
The animals in cages were marked by a line on the tail with an ink
marker.
Justification for the Choice
of Species
Normally females are used in the test according to OECD TG 423
because mostly females are the more sensitive gender.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test item was administered in a single dose by gavage using a metal stomach tube. Animals
were fasted prior to dosing (food but not water were withheld over-night). Following the period of
fasting, the animals were weighted and the test item administered. After the test item had been
administered, food was withheld for further 3-4 hours.
Doses:
The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg.
Available information indicates test item is likely to be nontoxic considering to acute toxicity. A
limit dose of 2000 mg/kg was used as starting dose. Group of 3 females were dosed. Test itemrelated
mortality was not observed during 24 hours group of 3 females were tested at the same dose.
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
Clinical Observation
Animals were observed individually immediately after the administration of the test item and then
0.5, 1, 2, and 4 hours later. Then each animal was inspected for the next 14 days.
Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory,
circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour
pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea,
lethargy, sleep and coma
Individual weights of animals were determined shortly before the test item was administered and at
weekly thereafter. Weight differences after first and second weeks after application were calculated
and recorded.
All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful
examination of external surface of the body, all orifices, and cranial, thoracic and abdominal
cavities and their contents. All gross pathological changes were recorded for each animal.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All 6/6 females survived the limit dose 2000 mg/kg.
Clinical signs:
No mortality was observed during the study. Animals lived through observation period without
important visible signs of intoxication. Neither change of health nor negative reactions were
registered.
Body weight:
The body weights of all animals were increasing during the study. No body weight losses were
observed between one and two week after dosing.
Gross pathology:
All animals were necropsied. During necropsy, no macroscopically changes were noticed.

Any other information on results incl. tables

     
     
     

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on OECD 423 Annex 2d: Test Procedure with a Starting Dose of 2000 mg/kg Body Weight it
can be concluded that the substance is classified in Category 5/Unclassified with
the cut off LD50 ≥ 5000 mg/kg, after single oral administration to Wistar rats.
Executive summary:

The test item administered to 6 females in limit dose 2000 mg/kg did not cause

death. All females survived the limit dose 2000 mg/kg. No body weight losses were observed

between one and two week after administration of the test item. No important signs of toxicity were

observed at the dosage of 2000 mg/kg during first 4 hours or in 14 day observation period. During

necropsy, no macroscopically changes were noticed.