1,4-dioxane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dioxane

EC Number:

204-661-8

EC Name:

1,4-dioxane

Cas Number:

123-91-1

Molecular formula:

C4H8O2

IUPAC Name:

1,4-dioxane

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation (mean): 226 g (males); 197 g (females)


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 %, 16 %, and 2 % (v/v)

MAXIMUM DOSE VOLUME APPLIED: 6 mL/animal

Doses:

200, 1600, 3200, 4000, 5000, and 6400 µL/kg bw (corresponding to approx. 206, 1648, 3296, 4120, 5150, and 6592 mg/kg bw) (recalculation of doses based on relative density of 1.03)

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: Weighing was performed only at the beginning of the study for dose calculation. Observation of clinical signs was performed several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, pathology

Statistics:

No statistics were performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 150 mg/kg bw

Based on:

test mat.

Mortality:

6592 mg/kg bw: 10/10 animals died within 48 hours
5150 mg/kg bw: 5/10 animals died within 7 days
At the lower doses between 4120 and 206 mg/kg bw no mortality was observed.

Clinical signs:

other: 6592 mg/kg bw: immediately after administration accelerated respiration, squatting posture and in some animals abdominal position were observed. After 5 min atony and apathy, after 10 min abdominal and lateral position, back posture, eye discharge and nar

Gross pathology:

Deceased animals:
- heart: acute dilatation; lungs: venous hyperemia, slightly edematous; stomach: bloody ulcerations; intestines: hematinized black contents, diarrheic; liver: pale; kidneys: pale; blood: coagulopathy.
Sacrificed animals:
- without abnormalities.

Any other information on results incl. tables

Mortality:

			Dead animals / treated animals after
Dose (mg/kg bw/d)	Conc. (%)	No of animals	1 h	24 h	48 h	7 d
6592	30	5 males	0/5	1/5	5/5	5/5
		5 females	0/5	3/5	5/5	5/5
5150	30	5 males	0/5	0/5	0/5	0/5
		5 females	0/5	1/5	1/5	5/5
4120	30	5 males	0/5	0/5	0/5	0/5
		5 females	0/5	0/5	0/5	0/5
3296	30	5 males	0/5	0/5	0/5	0/5
		5 females	0/5	0/5	0/5	0/5
1648	16	5 males	0/5	0/5	0/5	0/5
		5 females	0/5	0/5	0/5	0/5
206	2	5 males	0/5	0/5	0/5	0/5
		5 females	0/5	0/5	0/5	0/5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met