Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Referenceopen allclose all

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 Type:
other: Microfiche
Title:
Unnamed
Year:
1980
Report Date:
1980
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
salivation and tremor
Body weight:
no data
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

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).