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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28-07-2014 to 03-09-2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study under GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2-aminoethanol and ammonia reaction
EC Number:
800-253-4
Cas Number:
1419212-73-9
IUPAC Name:
Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2-aminoethanol and ammonia reaction
Constituent 2
Reference substance name:
Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products
IUPAC Name:
Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction by-products
Constituent 3
Reference substance name:
Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction
IUPAC Name:
Reaction products of C16 saturated and C18 unsaturated fatty acids and fatty acid glycerides with by-products from 2 aminoethanol and ammonia reaction
Constituent 4
Reference substance name:
Fatty acids, C12-18 , reaction products with ethanol, 2-amino, reaction products with ammonia, by products from
IUPAC Name:
Fatty acids, C12-18 , reaction products with ethanol, 2-amino, reaction products with ammonia, by products from
Test material form:
liquid: viscous
Details on test material:
Identification: Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products
Physical state / Appearance: brown extremely viscous liquid
Storage Conditions: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd.,Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 155-195 g
- Fasting period before study: overnight and 3-4 hours after docing
- Housing: ≤ 4 in solid floor polypropylene cages
- Diet: 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK, ad libitum:
- Water: ad libitum:
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): > 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE: arachis oil BP
- Concentration in vehicle: 30 and 200 mg/L
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: test substance did not dissolve/suspend in distilled water

Doses:
sighting dose: 300 and 2000 mg/kg bw
main study: 2000 mg/kg bw
No. of animals per sex per dose:
sighting study: 1 female/dose
main study: 4 females at 2000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Body weight: at study start and weekly thereafter
- Clinical signs: ½, 1, 2, and 4 hours after dosing and then daily for 14 days
- Mortality/morbidity: twice daily
- Necropsy : macroscopic examination
Statistics:
NA

Results and discussion

Preliminary study:
No mortality or signs of toxicity in females at 300 and 2000 mg/kg bw
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
1 female at 300 mg/kg bw: hunched posture 2 hours after dosing
Body weight:
within expected ranges
Gross pathology:
no abnormalities

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the testsubstance is > 2000 mg/kg bw
Executive summary:

Female rats (n=1) received a single dose of the test substance at 300 and 2000 mg/kg bw in a sighting study. In absence of mortality or signs of toxicity, additional 4 females were dosed at 2000 mg/kg bw. No mortality was observed in these females and no effects on body weight, clinical signs or gross examination were noted. The study followed the fixed dose procedure without any deviarions from the guideline. The LD50 is > 2000 mg/kg bw.