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Diss Factsheets

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:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
478-310-4
EC Name:
-
Cas Number:
53803-13-7
Molecular formula:
C9H21NO2
IUPAC Name:
Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid
Test material form:
other: Liquid
Details on test material:
Test was performed using commercial product DABCO TMR-7 which is 50% solution of Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid in 1,2-ethandiol, Batch #19847-85

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Ethane-1,2-diol
Doses:
Animals were dosed orally at the doses 50, 300, 500, 2000 mg/kg b.w.
No. of animals per sex per dose:
Initially three female rats were dosed at 2 000mg/kg b.w. Based on the response following doses were applied
Dose Male/Female treated Mortality
50 mg/kg 0/3 NA/0
300 mg/kg 3/3 1/1
500 mg/kg 0/3 NA/3
2000 mg/kg 0/3 NA/3
Control animals:
no
Details on study design:
Initially three female rats were dosed at 2 000mg/kg b.w. Based on the response additional groups of animals were dosed.
Animals were observed 0.5, 1, 2.3.4 hours postdose and then once daily for 14 days for mortality, toxicity and pharmacological effects.

Results and discussion

Preliminary study:
Initially three female rats were dosed at 2 000mg/kg b.w. All3 animals died within 3 minutes from dosing.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
165 mg/kg bw
Based on:
test mat.
Mortality:

Dose Male/Female treated Mortality
50 mg/kg 0/3 NA/0
300 mg/kg 3/3 1/1
500 mg/kg 0/3 NA/3
2000 mg/kg 0/3 NA/3
Clinical signs:
other: 50 mg/kg - no signs 300 mg/kg - 1 male and 1 female died within 4 h, lethargy was the only sign observed 500 mg/kg - lethargy,sagging eyelids, all 3 animals died within 2 h
Gross pathology:
50 mg/kg - normal
300 mg/kg - dead animals - abnormalities in lungs, liver, spleen, stomach, brown staining in nose/mouth, survivors - 3 animals had normal results, 1 animal had mottled kidneys
500 mg/kg - abnormalities in lungs, kidneys and spleen
2000 mg/kg - 2 animals no findings, 1 animal red areas on the lungs

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of the 50% solution of Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid in 1,2-ethandiol is 330 (235-464) mg/kg bw. The estimated oral LD50 of the Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is therefore 165 mg/kg b.w.
Executive summary:

Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid acute oral toxicity was tested with the result LD50 ca 165 mg/kg b.w.