Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted Dec. 2001
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted May 2008
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adoopted Dec. 2002
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine
EC Number:
942-330-6
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Reaction products of fatty acids, tall oil and fatty acids, C18 unsaturated, trimers and fatty acids, C18 unsaturated, dimers with (9Z)-octadec-9-en-1-amine
Details on test material:
- Name of test material (as cited in study report): Reaction mass of Fatty acids, tall-oil, compds. with oleylamine and Fatty acids, C18-unsatd., trimers, compds. with oleylamine
- Physical state: viscous light brown to clear liquid
- Analytical purity: The test item is a complex mixture of isomers and homologues components, so no purity can be stated. (For details see analytical report BASF study-No.: 13L00017)
- Purity test date: Feb.-April 2013
- Lot/batch No.: D987-AM-202011
- Expiration date of the lot/batch: 2013-04-18
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: app. 10 weeks
- Weight at study initiation: 172-191g
- Fasting period before study: 16h, water available ad lib.
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P) ad libitum; SDS Special Diets Services, 67122 Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app. 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Remarks:
(high dose was administered undiluted)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.23mL/kg b.w.
Doses:
300, 2000mg/kg
No. of animals per sex per dose:
3 (high dose), 6 (low dose, incl. repeat experiment)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, at least once daily on workdays thereafter
- Frequency of weighing: shortly before administration, weekly thereafter (additionally on day of death, if found dead or sacrificed moribund)
- Necropsy of all animals performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
< 2 000 mg/kg bw
Based on:
test mat.
Mortality:
In the 2000 mg/kg test group two animals were found dead on study day 8 or 9 after administration. Due to the high weight loss, the remaining animal of this test group was sacrificed in a moribund state on study day 9. No mortality occurred in the 300 mg/kg test groups.
Clinical signs:
In the animals of the 2000 mg/kg bw test group, impaired general state, dyspnoea, piloerection, reduced feces, and exsiccosis were noted from study day 2 or 3 onwards. In the animal that was sacrificed moribund, poor general state and cachexia were noted on study day 9.

In the first 300 mg/kg bw test group impaired general state, dyspnoea and piloerection were observed in all animals from hour 2 until hour 5 after administration and persisted in one animal until study day 3. In another animal these findings were noted again on study day 2 and 3. No clinical signs were observed during clinical examination in the second 300 mg/kg administration group.
Body weight:
In the 2000 mg/kg bw test group high weight loss was noted during the post observation period until study day 9, when the surviving animal was sacrificed moribund (app. -19% in all animals).
The mean body weight of the surviving animals in the 300 mg/kg test groups increased within the normal range throughout the study period.
Gross pathology:
In the animals that died Peyer’s plaques in the small intestine (one animal) and swollen lymph nodes in region of the small intestine and red discoloration of the small intestine in the second animal. In the animal that was sacrificed moribund swollen lymph nodes in region of the small intestine and red discoloration of the small intestine were also observed.

There were no macroscopic pathological findings in the surviving animals sacrificed at the end of the observation period (300 mg/kg, 6 females).

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information