Acetic anhydride

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP compliant, non-standard study, available as unpublished report, adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Intraperitoneal administration.
Male and female mice
Five animals per dose group
Acetic anhydride emulsion in olive oil

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acetic anhydride

EC Number:

203-564-8

EC Name:

Acetic anhydride

Cas Number:

108-24-7

Molecular formula:

C4H6O3

IUPAC Name:

acetyl acetate

Test animals

Species:

mouse

Strain:

NMRI

Details on test animals or test system and environmental conditions:

SPF-bred, WIGA, Sulzfeld
mean male bodyweight = 38g
mean female bodyweight = 27g .

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

olive oil

Details on exposure:

Emulsion of test material in olive oil.
Single intraperitoneal dose administered

Doses:

46.4, 68.1, 100 and 147 mg/kg bodyweight injected into the abdominal cavity.

No. of animals per sex per dose:

5/sex/dose level

Control animals:

no

Details on study design:

Four dose levels.
Animals monitored over 14 days and symptoms and deaths recorded at 1 hour, 24 hours, 48 hours, 7 days and 14 days post dose.
At the end of the 14 days the animals were killed following exposure to CO2 prior to examination of major internal organs.
Animals that died during the study were autopsied.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

50 mg/kg bw

Based on:

not specified

Mortality:

Most deaths were within 7 days.

Clinical signs:

Signs of toxicity included shivering, apathy, paraesthesia of the hind limbs, tonic/clonic convulsions and general poor condition

Gross pathology:

Animals that died during study: intra-abdominal percipitation
Animals sacrificed at termination: intra-abdominal adhesions

Any other information on results incl. tables

Mortality

Dose mg/kg	Concentration %	Number of Animals	Death within
			1 hour	24 hours	48 hours	7 days	14 days
147	1.47	5 male	0/5	5/5	5/5	5/5	5/5
		5 female	0/5	3/5	5/5	5/5	5/5
100	1.00	5 male	0/5	2/5	4/5	5/5	5/5
		5 female	0/5	0/5	2/5	5/5	5/5
68.1	0.681	5 male	0/5	0/5	1/5	4/5	5/5
		5 female	0/5	0/5	0/5	4/5	4/5
46.4	0.464	5 male	0/5	1/5	2/5	3/5	3/5
		5 female	0/5	0/5	1/5	1/5	1/5

Applicant's summary and conclusion

Conclusions:

The LD50 of acetic anhydride adimistered directly into the abdominal cavity was 50 mg/kg bodyweight.

Executive summary:

Groups of 5 male and 5 female NMRI mice were given a single dose of 46.4, 68.1, 100 or 147 mg acetic anhydride /kg bodyweight injected into the abdominal cavity. Animals were monitored over 14 days and symptoms and deaths recorded at 1 hour, 24 hours, 48 hours, 7 days and 14 days post dose. At the end of the 14 days the animals were killed following exposure to CO2 prior to examination of major internal organs. Animals that died during the study were autopsied.

Signs of toxicity included shivering, apathy, paraesthesia of the hind limbs, tonic/clonic convulsions and general poor condition.

The LD50 of acetic anhydride adimistered directly into the abdominal cavity was 50 mg/kg bodyweight.