Methanaminium, N,N,N-trimethyl-, 2,2-dimethylpropanoate (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

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.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

800 mg/kg bw

Based on:

act. ingr.

95% CL:

533 - 1 200

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 600 mg/kg bw

Based on:

test mat.

95% CL:

1 067 - 2 400

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

1 900 mg/kg bw

Based on:

test mat.

95% CL:

1 386 - 2 605

Effect levels 4

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

Applicant's summary and conclusion

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.