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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
the tested substance is the amine part of the compound
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 401), GLP compliant
Cross-reference
Reason / purpose for cross-reference:
read-across source

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
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
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 or test system 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 weekENVIRONMENTAL 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
Key result
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