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EC number: 293-014-3
CAS number: 91032-08-5
The test material did not cause any adverse effects after singel oral or
dermal administration to rats at a dose level of 2000 mg/kg bw.
Table: Clinical Signs - Individual Data
AnimalNo. / Sex
Step 1 (2000 mg/kg Body Weight)
1 / female
during the whole observation period
no signs of toxicity
2 / female
3 / female
Step 2 (2000 mg/kg Body Weight)
4 / female
5 / female
6 / female
Table: Body Weight Development - Absolute Body Weights in g and Body Weight Gain in %
Animal No. /Sex
Table: Findings of Necropsy - Individual Data
nsf = no specific findings
Table: LD50 Cut-Off
Number of Intercurrent Deaths
2000 mg/kg bw
bw = body weight
1.1. Summary Results
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended in the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.
Table: Results per Step
Number of Animals
All animals survived until the end of the study without showing any signs of toxicity.
Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step.
Species/strain: WISTAR Crl: WI(Han) rats
Number of animals: 3 per step / 2 steps performed
Vehicle: aqua ad injectionem
Method: OECD 423 EC 440/2008, Method B.1 tris OPPTS 870.1000 OPPTS 870.1100
Under the conditions of the present study, a single oral application of the test item Fatty acids, C16-18-, reaction products with diethanolamine to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
The median lethal dose of Fatty acids, C16-18-, reaction products with diethanolamine after a single oral administration to female rats, observed over a period of 14 days is:
LD50cut-off (rat): unclassified
2000 mg /kg bw
Crl: WI(Han) rats
(moistening): aqua ad injectionem
animals: 5 male and 5 female
exposure: 24 hours
EC 440/2008, Method B.3
Table: Results per Step
Numberof Intercurrent Deaths
Signs of toxicity related to dose
level used, time of onset and duration:
No treatment-related effects were
Effect on organs (related to dose
Signs of irritation:
No erythema or oedema was observed.
Scratches were observed in 1 of 5 male and female animals.
All signs of irritation were
reversible within the observation period.
Under the conditions of the present
study, single dermal application of the test item Fatty acids, C16-18-,
reaction products with diethanolamine to rats at a dose of 2000 mg/kg
body weight was associated with neither mortality nor signs of toxicity
but slight signs of irritation.
dermal LD50 was determined to be > 2000 mg Fatty acids, C16-18-,
reaction products with diethanolamine / kg body weight.
Acute exposure of rats via oral or dermal route did not result in any
adverse systemic or local effects.
Neither after oral nor after dermal exposure any mortalities were
detected at 2000 mg/kg bw. Therefore criteria for classification are not
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