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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15. Oct 1987 - 29. Oct 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Principles of method if other than guideline:
BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopentylamine
EC Number:
203-526-0
EC Name:
Isopentylamine
Cas Number:
107-85-7
Molecular formula:
C5H13N
IUPAC Name:
isopentylamine
Details on test material:
- Name of test material (as cited in study report): Isopentylamin

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR. K. THOMAE GMBH, Biberach, Germany
- Weight at study initiation: male: 191 g (mean); female: 189 g (mean).
- Fasting period before study: 16 h
- Housing: 5 animals per cage
- Diet: KLIBA-LABORDIAET 343, Klingentalmuehle AG, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2.15%, 4.64% or 10%
- Amount of vehicle (if gavage): 10 ml



Doses:
215, 464 or 1000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, at least once each workday.
- Frequency of weighing: dasy 0, 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
341 mg/kg bw
95% CL:
251 - 460
Mortality:
1000 mg/kg: 1 female died within 1 h. By 24 h all animals were dead.
464 mg/kg: 4 males and females each died within 24 h.
215 mg/kg: 1 female died within 13 days.
Clinical signs:
1000 mg/kg: After 30 min up to 1 h the animals showed dyspnea, apathy, abnormal position, staggering, piloerection, cyanosis, poor general state (see details in table in remarks on results).
464 mg/kg: dyspnea, apathy, piloerection, poor general state, staggering, abnormal position, spastic gait, exopthalmus, impaired general state (see details in table in remarks on results).
Body weight:
see detailed table in remarks on results.
Gross pathology:
Animals that died:
General congestion. Stomach/small intestine: mucosa reddened.
In one animal which died 13 days after substance administration cachexia and empty intestines were noted.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg )  Conc.  Gender  1 h  24 h  48 h  day 7  day 14  
 1000 10  male  0/5 5/5 5/5 5/5 5/5  
 1000 10  female  1/5 5/5  5/5  5/5 5/5  
 464   4.64  male 0/5  4/5  4/5  4/5  4/5  
464 4.64  female  0/5  4/5 4/5  4/5 4/5  
 215 2.15  male  0/5  0/5  0/5  0/5 0/5  
 215  2.15  female  0/5  0/5  0/5  0/5  1/5  

Weight (g):

 Dose (mg/kg)

 Gender  day 0  day 7  day 13      
1000  male 198 -    
1000  female 197 - -    
464  male 183 163 189    
464  female 182 199 208    
215 male  191 243 278    
215  female 189 211 209      

Clinical signs:

Dose (mg/kg)  1000     464     
 male  female  male  female    

Dyspnea

 30 min - 1 h

 30 min - 1 h

 30 min - 12 d

 30 min - 5 d

 

 

 

Apathy

 30 min - 1 h

 30 min - 1 h

 30 min - 8 d

 30 min - 5 d

 

 

 

Abnormal position

 1 h

 1 h

 1 h - 4 h

 1 h - 5 h

 

 

 

Staggering

 1 h

 1 h

 1 h - 11 d

 1 h - 5 d

 

 

 

Spastic gait

 -

 -

 1 d - 5 d

 1 d - 4 d

 

 

 

Piloerection

 30 min - 1 h

 30 min - 1 h

 30 min - 11 d

 30 min - 5 d

 

 

 

Exopthalmus

 -

 -

 4 h - 5 h

 -

 

 

 

Cyanosis  -  1 h -  -      
Impaired general state  -  -  11 d  -      
Poor general state   30 min - 1 h  30 min - 1 h  30 min - 8 d  30 min - 5 d      

min: minutes

h: hour

d: day

There is indication that the test substance causes local irritation to exposed tissue.

Harmful if swallowed.

Applicant's summary and conclusion