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Registration Dossier
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EC number: 478-310-4 | CAS number: 53803-13-7
Endpoint summary
Administrative data
Description of key information
The dermal LD50 for Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid was determined to be 800 mg/kg b.w.
The oral LD50 for Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid was determined to be 165 mg/kg b.w.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- 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
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- 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. - Preliminary study:
- Initially three female rats were dosed at 2 000mg/kg b.w. All3 animals died within 3 minutes from dosing.
- 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 - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 165 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- other: 1,2-ethanediol
- Details on dermal exposure:
- Prior to the day of application the dorsal area of the trunk of each animal was clipped free of hair. The area was approximately 10% of the animal's body surface.
- Duration of exposure:
- 24 hours
- Doses:
- Following dosing level was used - 2000, 1000, 400 mg/kg b.v. (related to DABCO TMR-7)
- No. of animals per sex per dose:
- 3 males and 3 females per dose.
- Control animals:
- no
- Details on study design:
- Animals were observed 1,2, and 4 hours postdose and once daily for 14 days for toxic and pharmacological effects. Body weight was recorded pre-test and at day 7 and 14.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 800 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 533 - 1 200
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 067 - 2 400
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 386 - 2 605
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 360 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 634 - 2 918
- Mortality:
- Initially three animals per sex were dosed at 2,000 mg/kg b.w. Based on the response following doses were applied
Dose Male/Female treated Mortality
400 mg/kg 3/3 0/0
1000 mg/kg 3/3 0/1
2000 mg/kg 3/3 2/2 - Clinical signs:
- other: 2000 mg/kg dose prior to mortality on day 0, cloudy discharge from the eye, instances of lethargy, nose/mouth area wet and convulsion were observed. Instances of diarrhea and few feces were observed in survivors. Dermal effects were absent throughout the
- Gross pathology:
- 2000 mg/kg dose - For animals who died, necropsy results revealed abnormalities of the treated skin.eyes, nose, mouth, pancreas spleen and liver. Necropsy of survivors were normal.
1000 mg/kg dose - animal who died showed abnormalities in anogenital area, nose/mouth area, spleen and liver
400 mg/kg - necropsy results revealed abnormalities of the pancreas and thymus - Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of the 50% solution of Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid in 1,2-ethandiol is 1600 (1067-2400) mg/kg bw. The estimated dermal LD50 for Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid is therefore 800 mg/kg b.w.
- Executive summary:
The dermal LD50 for Methanaminium N,N,N-trimethyl-, salt with 2,2-dimethylpropanoic acid was determined to be 800 mg/kg b.w.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 800 mg/kg bw
Additional information
Justification for classification or non-classification
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