3-(methylamino)propane-1,2-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1989

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:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

The study was performed as a limit test with only one dose level of 2000 mg/kg bw

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methylaminopropanediol

IUPAC Name:

Methylaminopropanediol

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Methylaminopropandiol
- Physical state: viscous, transparent liquid
- Sample No.: 204-027-88

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: 142 - 153 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: no, as the rats were born next door to the laboratory and had been kept in the same environment as during the experiment
- fasting period before study - 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 6 per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Doses:

2000 mg/kg body weight, volume was 1.0mL/g 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.

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: 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

Conclusions:

Since no rats died from the treatment, the oral LD50 must be above 2000 mg Aminopropandiol/kg body weight.