1-aminopropan-2-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06. Oct 1965 - 25. Oct 1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1965

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

conducted according to an internal BASF method

Deviations:

not applicable

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 type:

other: BASF-test

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-aminopropan-2-ol

EC Number:

201-162-7

EC Name:

1-aminopropan-2-ol

Cas Number:

78-96-6

Molecular formula:

C3H9NO

IUPAC Name:

1-aminopropan-2-ol

Specific details on test material used for the study:

- purity: 98%

Test animals

Species:

rat

Strain:

other: US-rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 142-220 g (mean); female: 136-194 g (mean)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

0.2, 1.6, 2.0, 2.5, 3.2, 6.4 mL/kg bw (194, 1552, 1940, 2425, 3104, 6208 mg/kg bw ; conversion in mg/kg bw was calculated from the original ml/kg values by using the density of 0.97g/cm3 (according to the BASF MSDS).

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: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 813 mg/kg bw

Remarks on result:

other: The LD50 was calculated from the original mL/kg values by using the density of 0.97g/cm3

Mortality:

See details in table 1 on any other information.

Clinical signs:

other: After the application the high dose animals showed restlessness, stagger, creep, slight abdominal position, anemia and mouth discharge. At all dose groups compulsive chewing, dyspnoea and apathy were observed. In the middle groups also tonic-clonic convul

Gross pathology:

6208 mg/kg: red discoloration of abdominal viscus.
3104 mg/kg: 2 animals showed reddish livid discoloration of the abdominal viscus.
2425 mg/kg: 2 animals showed irritation of the bowel and 1 animal dilatation of the stomach.
1940 mg/kg: 1 animal showed bronchitis and bronchiectasia.
1557 mg/kg: no abnormalities.
194 mg/kg: 2 animals showed bronchitis and bronchiectasia.

Other findings:

The test substance caused systemic toxicity, including mortality, after a single ingestion.

Any other information on results incl. tables

Table 1: Mortality observed in animals during the study.

Dose (mg/kg bw)

Conc.(%)

1h

24 h

48 h

7 days

14 days

6208

30

0/10

10/10

10/10

10/10

10/10

3104

30

1/10

7/10

7/10

7/10

-

2425

20

0/10

2/10

2/10

2/10

2/10

1940

20

0/10

1/10

1/10

1/10

1/10

1557

20

0/10

0/10

0/10

0/10

0/10

194

2

0/10

0/10

0/10

0/10

0/10

The 3 surviving animals of the 3104 mg/kg bw group were sacrificed on day 7.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance caused deaths from doses of 1,940 mg/kg bw to 6,208 mg/kg bw. More than half of the animals dies at doses of 3,04 mg/kg bw and 6,208 mg/kg bw.
Based on the LD50 = 2,813 mg/kg bw a classification according to GHS within REACH is not met. However, based on the GHS UN, a classification for Cat. 5 for acute toxicity is reasonable.