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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:
24 April 2017 - 16 May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
2001
Deviations:
yes
Remarks:
The 1-hour observation for the animals treated at a dose level of 300 mg/kg bw was performed 8 minutes late due to a fire drill. This deviation was considered to have not affected the integrity or validity of the study.
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
EC Number:
308-415-1
EC Name:
9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized
Cas Number:
97953-16-7
IUPAC Name:
9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized

Test animals

Species:
rat
Strain:
Wistar
Remarks:
RccHan:WIST
Sex:
female
Details on test animals or test system and environmental conditions:
Batch: RL55/17
Purity: 100%
Physical state/Appearance: yellow to brown paste
Expiry Date: 15 March 2018
Storage Conditions: room temperature in the dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
Sighting test: 300 mg/kg bw and 2000 mg/kg bw
Actual test: 2000 mg/kg bw
No. of animals per sex per dose:
Five animals at 2000 mg/kg bw
One animal at 300 mg/kg bw
Control animals:
no

Results and discussion

Preliminary study:
At 300 mg/kg bw there was no mortality and hunched posture was noted 4 hours after dosing. No other signs of systemic toxicity were noted during the observation period. The animal showed expected gains in body weight over the observation period and no abnormalities were noted during necropsy.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal (of 5) was found dead 2 days after dosing.
Clinical signs:
Hunched posture and noisy respiration were noted during the day of dosing, in the initial treated animal. No signs of systemic toxicity were noted during the observation period in the surviving animals.
Body weight:
Surviving animals showed expected gains in body weight , except for two animals which showed either no gain in body weight or body weight loss during the first week, but expected gain in body weight during the second week.
Gross pathology:
Abnormalities noted at necropsy of the animal that died during the study were dark and patchy pallor of the liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the substance in the female Wistar strain rat was estimnated to be greater than 2000 mg/kg bw.
Executive summary:

In an acute toxicity study the substance was administered to Wistar rats (5 female animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration) following a sighting test with one animal at a dose of 300 mg/kg bw. There was one death 2 days after dosing and hunched posture and noisy respiration were noted during the day of dosing in the initial treated animal. Surviving animals showed expected gains in body weight , except for two animals which showed either no gain in body weight or body weight loss during the first week, but expected gain in body weight during the second week. Abnormalities noted at necropsy of the animal that died during the study were dark and patchy pallor of the liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study. The acute oral median lethal dose (LD50) of the substance in the female Wistar strain rat was estimnated to be greater than 2000 mg/kg bw.

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