Crotonaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: glp status not included

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Principles of method if other than guideline:

none

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Crotonaldehyde

EC Number:

224-030-0

EC Name:

Crotonaldehyde

Cas Number:

4170-30-3

Molecular formula:

C4H6O

IUPAC Name:

but-2-enal

Details on test material:

yellow liquid
recieved from sponsor on December 12, 1979
Stored refrigerator

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

purchased from GIBCO Animal Resources laboratorues (Madison, Wisconsin).

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

1.0 ml per 100 grams body weight

Doses:

64.5, 107.5, 180, 300 and 500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

none

Statistics:

none

Results and discussion

Preliminary study:

All animals were fasted overnight prior to and for one hour after dosing. Water was freely available at all times. The test article was administered as a single oral dose by gavage to five groups of two male and two female rats at dose levels of 5000, 1600, 500, 160 and 50 mg/kg. The range of intital weights was 180-203 g for males and 189-204 g for females. All animals were observed for 3 days for mortality. No deaths were observed in males dosed with 50 or 160 mg/kg. All males dosed with 500, 1600 or 5000 mg/kg died within 30 min of dosing. No females died at 50 mg/kg; one female died at 160 mg/kg and all females died at higher doses within one hour.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

174 mg/kg bw

95% CL:

131 - 231

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

165 mg/kg bw

95% CL:

131 - 231

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

175 mg/kg bw

95% CL:

107 - 254

Mortality:

14 / 20 at 180 mg/kg
all animals in the 300 and 500 mg/kg dose groups
All deaths occurred within 24 hours post-treatment.

Clinical signs:

other: lethargy, salivation, ataxia, lacrimation, soft feces and squinted eyes. No significant clinical observations were seen in animals living past day one (one female exhibited extended salivation, rhinorrhea and wheezing).

Gross pathology:

of animals found dead:
LUNGS: dark areas (8/27), discoloration (13/27), mottling (10/27), congestion (5/27)
SPLEEN: dark areas (3/27)
STOMACH: distention with compound colored fluid (14/27), distention with fluid (10/27), distention with gas (15/27)
INTESTINES: distention with gas (2/27) and fluid (14/27)

In animals sacrificed on Day 14:
discoloration of, dark red areas and white foci on the lungs, a dark red and slightly enlarged uterus in a female in the 64.5 mg/kg dose group adn a cyst and fluid in the uterus of a female in the 107.5 mg/kg dose group.

Other findings:

none

Any other information on results incl. tables

 

Cumulative Mortality

Oral LD50 Determination in Rats with Crotonaldehyde

Dose	Number and sex	Cumulative mortality
		Day
		1	2	3	4	5	6	7-14
64.5	5M	0	0	0	0	0	0	0
64.5	5F	0	0	0	0	0	0	0
107.5	5M	0	0	0	0	0	0	0
107.5	5F	0	0	0	0	0	0	0
180	5M	4	4	4	4	4	4	4
180	5F	3	3	3	3	3	3	3
300	5M	5	5	5	5	5	5	5
300	5F	5	5	5	5	5	5	5
500	5M	5	5	5	5	5	5	5
500	5F	5	5	5	5	5	5	5

Individual and Mean Body Weights (g)

Oral LD50 Determination in rats with crotonaldehyde

Dose Level (mg/kg)	Animal No	sex	Pre-fast	Pre-dose	Day 14^a
64.5	8959	M	210	185	261
	8960	M	220	191	273
	8961	M	207	175	274
	8962	M	214	186	272
	8963	M	212	185	290
	MEAN	M	213	184	274
	8964	F	214	189	222
	8965	F	201	181	229
	8966	F	196	181	201
	8967	F	197	180	218
	8968	F	190	179	209
	MEAN	F	200	181	216
107.5	8969	M	214	191	245
	8970	M	222	197	280
	8971	M	226	197	289
	8972	M	207	180	269
	8973	M	222	198	263
	MEAN	M	218	193	269
	8974	F	203	184	230
	8975	F	194	177	223
	8976	F	196	174	211
	8977	F	196	180	220
	8978	F	200	181	214
	MEAN	F	198	179	220
180	8979	M	191	170	(170)
	8980	M	192	170	(166)
	8981	M	226	194	278
	8982	M	222	200	(201)
	8983	M	190	171	(168)
	MEAN	M	204	181
	8984	F	202	182	(182)
	8985	F	190	163	231
	8986	F	201	182	(189)
	8987	F	206	187	(187)
	8988	F	208	192	229
	MEAN	F	201	181	230
300	8989	M	225	206	(204)
	8990	M	214	183	(182)
	8991	M	224	200	(198)
	8992	M	229	201	(199)
	8993	M	198	173	(172)
	MEAN	M	218	193
	8994	F	202	180	(177)
	8995	F	198	180	(177)
	8996	F	205	185	(184)
	8997	F	209	186	(187)
	8998	F	218	194	(194)
	MEAN	F	206	185
500	8999	M	225	196	(195)
	9000	M	232	206	(208)
	9001	M	194	172	(171)
	9002	M	200	185	(184)
	9003	M	220	194	(194)
	MEAN	M	214	191
	9004	F	198	180	(177)
	9005	F	204	185	(185)
	9006	F	191	172	(170)
	9007	F	214	173	(173)
	9008	F	221	196	(197)
	MEAN	F	206	181

a         Body weight calculations in paranthesis were measured at the time of death and were excluded from the mean calculations

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: US CPSC / US OSHA

Conclusions:

oral LD50 rats =174 mg/kg

Executive summary:

Crotonaldehyde was testing in sprague dawley male and females rats for acute oral toxicity by gavage. The test stubstance was administered in corn oil. Body weights and pathology were conducted on all animals as well as clinical signs observations. The result of the study was that the oral LD50 in rats (male and female combined) is 174 mg/kg.