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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 September 1993 and 27 October 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the OECD guideline 401 and in compliance with GLP.

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:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropane-1,2-diol
EC Number:
210-475-8
EC Name:
3-aminopropane-1,2-diol
Cas Number:
616-30-8
Molecular formula:
C3H9NO2
IUPAC Name:
3-aminopropane-1,2-diol
Details on test material:
- Name of test material (as cited in study report): Aminopropandiol
- Physical state: a yellow, viscous, transparent liquid
- Lot/batch No.: 1201-362-93
- Storage condition of test material: refrigerator at 5 °C

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Mollegaard Breeding Centre, Denmark
- Age at study initiation: 6- 7 weeks old
- Weight at study initiation: 135 - 156 g
- Housing: Macrolone cages Type III (2 or 3 to a cage)
- Diet (e.g. ad libitum): A complete rodent diet, "Altromin 1314" from Chr. Petersen A/S, DK-4100, Ringsted, ad libitum
- Water (e.g. ad libitum): yes, acidified with hydrochloric acid to pH 2.5
- Acclimation period: six days
- fasting period before study - 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 55 plus or minus 15
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
Doses:
2000 mg/kg body weight, volume was 10mL/kg body weight.
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1,3 and 6 hours after administration and thereafter daily for a period of 14 consecutive days. Bodyweights were recorded onday 0, 7 and 14. All rats were killed on day 14 and subjected to a gross autopsy examination.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None.
Clinical signs:
other: On day of dosing, one rat had piloerection. From day 1 and throughout the 14 day observation period all rats showed normal behaviour and appearance.
Gross pathology:
No gross pathological findings.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information: or not classifed (CLP)
Conclusions:
Since no rats died from the treatment, the oral LD50 must be above 2000 mg Aminopropandiol/kg body weight.