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Description of key information

Under the conditions of the presented OECD 401 study, a single oral application of the test item isooctadecanoic aicd to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The source acute toxicity study (oral application) was conducted with neat isooctadecanoic acid. The read across source substance is considered a structural analogue by taking into account 1. physico-chemical properties (surface active properties, logKow, water solubility) and the identical chemical structure of the test item's organic moiety (i.e. anionic isooctadecanoate part of potassium soap of isooctadecanoic acid). The potassium cation is considered not of toxicological relevance due to high tolerance in humans and rats after oral administration and high renal excretion capacities (Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission related to the Tolerable Upper Intake Level of Potassium, The EFSA Journal (2005) 193, 1-19 and the EFSA Journal 2016;14(10):4592 ff.). Therefore the results of the source substance are considered relevant for human health endpoint acute toxicity and consecutive risk assessment of acute systemic effects after single dose application via oral route (see supporting document on justification of read across approach). See read across document for further details.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Name of test material (as cited in study report): Prisorine 3505
Physical state: liquid
Analytical purity: approx. 100 %
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test animals

Source: Charles River Wiga GmbH, Sulzfeld, Germany
Age at study initiation: 8 weeks
Weight at study initiation: range between 120 and 250 g
Fasting period before study: overnight (prior to dosing) until approximately 3 hours after administration
Housing: individually housed in polycarbonate cages containing purified sawdust as bedding material
Diet (ad libitum): standard pelleted laboratory animal diet
Water (ad libitum): tap water (via automatic nozzles)
Acclimation period: at least five days

Environmental conditions

Temperature (°C): 19 - 21
Humidity (%): 40 - 60
Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Test article was administered once only gavage using a stainless steel stomach cannula attached to a disposable plastic syringe. The dose volume (ml/kg bodyweight) used was calculated as follows: dose (g/kg bodyweight) / specific gravity (g/ml). Specific gravity used was 0.89 g/ml.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Clinical observations were performed on the day of dosing (approximately once every two hours) and once daily thereafter for 14 days. Any signs of toxicity were recorded along with the time of onset and duration. Individual bodyweights were measured weekly. At the end of the study (day 14), all animals were anesthetized by CO2/O2 inhalation, subsequently killed by CO2 and subjected to necropsy.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat. (total fraction)
Mortality:
no mortality occurred
Clinical signs:
no signs of systemic toxicity were observed during the 14 day observation period
Body weight:
all animals showed bodyweight gain
Gross pathology:
macroscopic examination of animals at termination did not reveal any abnormalities that were considered to be treatment related
Interpretation of results:
GHS criteria not met
Conclusions:
Since no mortality occurred, the oral LD50 value for both males and females was noted as exceeding 2000 mg/kg bodyweight.
Executive summary:

Under the conditions of the presented OECD 401 study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality.


The median lethal dose of after a single oral administration to rats, observed over a period of 14 days is LD50 > 2000 mg/kg bw.


According to Annex I of Regulation (EC) 1272/2008 the test item isostearic acid as well as the potassium salt of isostearic acid (see justification for read-across) have no obligatory labelling requirement for toxicity and are not classified.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

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