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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diisopropanolamin asymmetrisch
- Lot/batch No.: 7752
- Purity: 99.261% (GC)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: DR. K. THOMAE GMBH
- Age at study initiation: young adult animals
- Weight at study initiation: 150 - 300 g
- Fasting period before study: 16 h before administration
- Housing: single housing
- Diet: Kliba-Labordiaet 343, Klingenthalmuehle AG, CH-4303 Kaiseraugust, 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:
olive oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: The test substance is insoluble in aqua bidest
- Concentration in vehicle: 20 or 40 g/100 ml for the 1000 or 2000 mg/kg bw dose, respectively
- Amount of vehicle: 5 ml/kg bw

Doses:
1000 and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Twice each workday and once on weekends
- Frequency of weighing: Individual body weights shortly before application (day 0), weekly thereafter and at the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No statistics needed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured.
Clinical signs:
No symptoms were observed.
Body weight:
The expected body weight gain has been observed in the course of the study.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Any other information on results incl. tables

Mean body weights.

   male     female     
 Dose  1000 mg/kg  2000 mg/kg  1000 mg/kg  2000 mg/kg  
 day 0 (before application)  181  200  189  188  
 day 7  248  264  220  215  
 day 12  273  -  224  
 day 13  -  301  -  226  

Applicant's summary and conclusion