Propan-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(prior to GLP, only two doses tested, post exposure period 7 days)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(only two doses tested, study period only 7 days)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propan-1-ol

EC Number:

200-746-9

EC Name:

Propan-1-ol

Cas Number:

71-23-8

Molecular formula:

C3H8O

IUPAC Name:

propan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

- Analytical purity: 99.5%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Gassner
- Mean body weight range at study initiation: 259-262g (male), 174-178g (female)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 35%

MAXIMUM DOSE VOLUME APPLIED:

Doses:

8250 and 10000 µl/kg bw (approx 6,600 and 8000 mg/kg; conversion with density 0.8 g/cm3 (20°C))

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: animals were checked for mortality 1h after application (day 1), then on day 2, day 3 and day 7 of the study. Weighing was performed on day of application (day 1) then on day 4 and day 7. Clinical signs of toxicity were observed several times on day of application then on days 4, 5, 6 and 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 8 000 mg/kg bw

Mortality:

see table 1 below

Clinical signs:

other: DAY 1 (similar symptoms in both dose groups) - Immediately after application: irregular and intermittent breathing, apathy, abdominal and lateral position, atony, exsicosis - 1h after application: irregular and intermittent breathing, apathy, abdominal an

Gross pathology:

Animals that died (8250 and 10000 µl/kg bw)
- Heart (acute dilation, acute congestion), Stomach (redness), Intestine (hemorrhagic and diarrhetic contents)

Survivors (till day 7)
- No adverse gross pathological finding observed

Any other information on results incl. tables

Table 1: Mortality of Spraque-Dawley Rats after Single Oral Dosage (gavage) with Propan-1-ol

	No. of animals	Death within
		1h	24h	48h	7 days
6600 mg/kg bw	5 males	0/5	0/5	0/5	0/5
	5 females	0/5	1/5	2/5	2/5
8000 mg/kg bw	5 males	0/5	3/5	3/5	3/5
	5 females	0/5	1/5	1/5	1/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met