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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[[3-(dimethylamino)propyl]amino]propiononitrile
EC Number:
274-159-1
EC Name:
3-[[3-(dimethylamino)propyl]amino]propiononitrile
Cas Number:
69852-45-5
Molecular formula:
C8H17N3
IUPAC Name:
3-{[3-(dimethylamino)propyl]amino}propanenitrile
impurity 1
Chemical structure
Reference substance name:
3,3'-[[3-(dimethylamino)propyl]imino]bispropiononitrile
EC Number:
275-331-9
EC Name:
3,3'-[[3-(dimethylamino)propyl]imino]bispropiononitrile
Cas Number:
71326-27-7
Molecular formula:
C11H20N4
IUPAC Name:
3,3'-{[3-(dimethylamino)propyl]imino}dipropanenitrile
Test material form:
liquid
Remarks:
colorless

Test animals

Species:
rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
Healthy random bred rats of the Tif: RAIf (SPF) strain raised on our premises were used for these experiments. They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a minimum of 4 days and the initial body weight ranged from 160 to 180 grams.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10, 20, 30, 50% of formulation

Doses:
1000, 2150, 2780, 3170, 3590 and 4640 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 284 mg/kg bw
95% CL:
>= 2 026 - <= 2 576
Mortality:
Deaths occured after 24 hours at 2150 mg/kg dosage. 100% mortality was seen at 4649 mg/kg after 24 hours
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position and ruffled fur. Sedation became more accentuated as the dose was increased. The surviving animals recovered within 8 to 9 days.
Body weight:
Not recorded
Gross pathology:
No substance related gross organ changes were seen

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral LD50 of TK 12271 in rats of both sexes observed over a period of 14 days is 2284 (2026-2576) mg/kg. The test material has therefore a slight acute toxicity to the rat by this route of administration.