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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified

Test material

1
Chemical structure
Reference substance name:
(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide
EC Number:
246-584-2
EC Name:
(Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide
Cas Number:
25054-76-6
Molecular formula:
C25H48N2O3
IUPAC Name:
N-(carboxymethyl)-N,N-dimethyl-3-(oleoylamino)propan-1-aminium hydroxide
2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Dihydrogen oxide
3
Chemical structure
Reference substance name:
Propane-1,2-diol
EC Number:
200-338-0
EC Name:
Propane-1,2-diol
Cas Number:
57-55-6
Molecular formula:
C3H8O2
IUPAC Name:
propylene glycol
4
Chemical structure
Reference substance name:
Sodium chloride
EC Number:
231-598-3
EC Name:
Sodium chloride
Cas Number:
7647-14-5
Molecular formula:
ClNa
IUPAC Name:
sodium chloride
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Initial testing with 5 females and 5 females will be performed at a dose of 5000 mg/kg. If mortality does not exceed 50% at this dose level, no further dose levels will be tested, If mortality os produced, additional dose levels will be performed in order to obtain the LD50 value. All animals will be dosed by oral gavage with the rest material
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
All animals will be individaully housed in stainless stell cages and offered food and water ad libitum. All test animals will be fasted overnight prior to dosing. Following dosing, all test animals will be oserved daily for 14 days following dosing for any toxic or deleterious effects, The weight of each animal will be determined prior to dising, at death, or at the end of the 14 day observation period.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no mortalities observed during the study
Clinical signs:
There were no clinical signs of toxicity observed during the study
Gross pathology:
No gross changes observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Acute oral LD50 was found to be > 2000 mg/kg
Executive summary:

Based on the results of this study, the LD50 of the test material is considered to be greater than 2000 mg/kg and does not meet the GHS classification criteria for acute toxicity.