Benzyldimethylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No OECD guideline or GLP defined; all essential data reported.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

The acute toxicity and primary irritancy of N-Benzyl-N,N-Dimethylamine

Author:

Ballantyne B, Dodd DE, Nachreiner Dj, Myers RC

Year:

1985

Bibliographic source:

Drug and Chemical Toxicology, 8; 43-56 (1985)

Reference 2

Reference Type:

other: Microfiche

Title:

Unnamed

Year:

1980

Report date:

1980

Reference 3

Reference Type:

publication

Title:

Comparative acute toxicity and primary irritancy of various classes of amines

Author:

Myers R.C. et al.

Year:

1997

Bibliographic source:

Toxic Substance Mechanisms, 16: 151-193 (1997)

Materials and methods

Principles of method if other than guideline:

Undiluted test material was administered by gavage, using a ball-ended stainless steel needle attached to a syringe, to groups of 5 male Wistar-derived rats of 90-120 g and 3-4 weeks of age. Animals were observed daily for signs of toxicity over a 14-day postdosing period, at the end they were subjected to gross pathological examination.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzyldimethylamine

EC Number:

203-149-1

EC Name:

Benzyldimethylamine

Cas Number:

103-83-3

Molecular formula:

C9H13N

IUPAC Name:

benzyldimethylamine

Details on test material:

Purity: 99.2 %
Density: 890 mg/ml at 25 C
Molecular Weight: 135.23
Boiling Point: 179.6°C
Vapor Pressure: 1.31 Torr at 20°C
1.82 Torr at 25°C
10.00 Torr at 55°C
50.00 Torr at 91°C
Flash Point: 57°C (Cleveland Open Cup)
Solubility: Readily soluble in aqueous acids, methanol, acetone and benzene. Water solubility, 0.12 g/dl.
Specific Gravity: 0.89 (25°C)
Saturated Vapor Concentration: 14430 mg/m³ (25°C)
Conversion Factors: 1 ppm= 5.53 mg/m³ (25°C, 760 Torr)
1 mg/m³= 0.181 ppm (25°C, 760 Torr)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90-120 g

ENVIRONMENTAL CONDITIONS
- Temperature (°F) 68-80:
- Humidity (%):39-65
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Undiluted Tets material was administered by gavage, using a ball-ended stainless steel needle attached to a syringe

Doses:

0.5 , 1.0, 2.0 ml/kg bw = 445, 890, 1780 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Undiluted test material was administered by gavage, using a ball-ended stainless steel needle attached to a syringe, to groups of 5 male Wistar-derived rats of 90-120 g and 3-4 weeks of age. Animals were observed daily for signs of toxicity over a 14-day postdosing period, at the end they were subjected to gross pathological examination.

Statistics:

moving average method

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

0.65 mL/kg bw

95% CL:

0.48 - 0.88

Remarks on result:

other: (approx. 579 mg/kg bw) Signs of toxicity within a few min after dosing. tremor and salivation; deaths occurred within 10 to 90 min after dosing; necropsy: Dead rats: congestion in stomach and intestines, hemorrhages in stomach, Survivors: no findings

Mortality:

0.5 ml/kg bw: 1/5 rat 1.5 h post dosing
1.0 ml/kg bw 5/5 rats 7-20 min post dosing
2.0 ml/kg bw: 5/5 rats 10-20 mi post dosing

Clinical signs:

other: other: salivation and tremor

Gross pathology:

Gross necropsy findings:
Dead animals: congestion in stomach and intestines,hemorrhages in stomach
Survivors: no abnormal findings

Other findings:

no data

Any other information on results incl. tables

RS-Freetext:
Mortality:
Dose       %       Time after appl.
low        20          1.5 h
medium    100         7-20 min
high      100        10-20 min

LD50 = 0.65 ml/kg bw  (0.48-0.88 ml/kg bw)
= 579 mg/kg bw 
Signs of toxicity: Tremors, salivation, death within few minutes to 1.5 h.

Gross necropsy findings:
Dead animals: congestion in stomach and intestines,hemorrhages in stomach
Survivors:    no abnormal findings

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Executive summary:

In an acute oral toxicity study undiluted test material was administered by gavage to groups of 5 male Wistar-derived rats of 90-120 g and 3-4 weeks of age. Following doses were tested: 0.5 , 1.0, 2.0 ml/kg bw (445, 890, 1780 mg/kg bw) Animals were observed daily for signs of toxicity over a 14-day postdosing period, at the end they were subjected to gross pathological examination. All animals died at a dose of 2.0 and 1.0 ml/kg bw, but only 1 of 5 at 0.5 ml/kg, indicating a steep slope to the response. Deaths occurred within 10 to 90 minutes after dosing, with the latency increasing as dosage decreased. Signs of toxicity included tremors and salivation which were seen within a few minutes after dosing. Autopsy examination of dead animals showed congestion and hemorrhages of the stomach, and intestinal congestion. Survivors of the 0.5 ml/kg bw group, sacrificed at the end of the 14 -day postdosing observation period, showed no gross abnormalities at autopsy. The LD50 was 0.65 ml/kg bw (resp. 579 mg/kg bw, Ballantyne1985).