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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 03, 2007 to October 10, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
Molecular formula:
UVCB
IUPAC Name:
Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
Test material form:
solid
Remarks:
Paste

Test animals

Species:
rat
Strain:
other: HanRcc: WIST(SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 11 weeks
- Weight at study initiation: 165.1 - 186.2 9 at day of application
- Fasting period before study: for approximately 17 to 18 h (access to water was permitted). Food was provided again approximately 3 h after dosing
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland)
- Diet: ad libitum; pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 23/07 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland)
- Water: ad libitum; community tap water from Füllinsdorf
- Acclimation period: 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 -70 %
- Air changes (per hr): 10-15 air changes per h
- Photoperiod (hrs dark / hrs light): the Iightening was in a 12-h Iight/dark-cycle.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Maximum dose volume applied: 2000 mg/kg body weight
Doses:
Dose levels: 2000 mg/kg body weight
Concentrations: 0.2 g/mL
Dosing: one single application by gavage
Dosing volume: 10 mL/kg bw
The test substance was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume).
Afterwards, the test substance preparation was warmed up to 50°C. The formulations were prepared using a suitable homogenizer. The test substance preparation was kept at room temperature for cooling and was administered when a temperature between 20°C and 30°C is reached. The temperature was measured before treatment with a thermometer and reached 24°C and 25.8°C.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. No organs or tissues were retained.
- Frequency of observations and weighing:

- Mortality / Viability and Clinical Signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 and twice daily during days 2-15. All abnormalities were recorded.

- Body Weights: On test days 1 (prior to administration), 8 and 15.
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Remarks:
No animal died
Remarks on result:
other: No animal died
Mortality:
No deaths occurred during the study.
Clinical signs:
other: No clinical signs were observed during the course of the study.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance, 'di-C16-18 and C18-unsatd. AAEMIM-MS', according to OECD Guideline 423 (Acute Toxic Class Method), in compliance with GLP. Three FemaleHanRcc: WIST(SPF)rats were administered the test substance by oral gavage at a dose of 2000 mg/kg bw. Following administration, the animals were observed for 14 d and mortality, clinical signs and body weights were recorded daily. At the end of this period, rats were examined for macroscopic and microscopic abnormalities. There was no mortality in this study. No evidence of systemic toxicity was noted during the study period. No toxicologically significant effects on bodyweight were recorded during the study period and no abnormalities were seen at necropsy of animals killed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be >2000 mg/kg bw (Arcelin, 2010).