Crotonaldehyde

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: publication

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2006

Materials and methods

Principles of method if other than guideline:

sperm head abnormality assay

GLP compliance:

not specified

Type of method:

in vivo

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:

no data

Test animals

Species:

mouse

Strain:

Swiss

Sex:

male

Details on test animals or test system and environmental conditions:

laboratory bred swiss albino mice were obtained from central Drug Research institute (Lucknow) and maintained in animal house of the laboratory conducing the study.
6 to 8 weeks old

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

olive oil

Details on exposure:

none

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

none

Duration of treatment / exposure:

1 IP dose at 8, 16 or 32 ul/kg bw
animals were sacrificed 1, 3 or 5 weeks after treatment.

Frequency of treatment:

once

Duration of test:

none

Doses / concentrations

Remarks:

Doses / Concentrations:
8, 16, or 32 ul/kg bw
Basis:
nominal conc.

No. of animals per sex per dose:

5 male per dose and time (15 per dose total)

Control animals:

yes, concurrent vehicle

Details on study design:

none

Statistics:

student's t test

Results and discussion

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

8 other: ul/kg bw

Sex:

male

Basis for effect level:

other: no abnormal sperm morphology

2

Dose descriptor:

LOAEL

Effect level:

16 other: ul/kg bw

Sex:

male

Basis for effect level:

other: abnormal sperm head morphology

Observed effects

no data

Any other information on results incl. tables

Effect of crotonaldehyde treatment on the incidence of sperm abnormality in Swiss albine mice at different stages of spermatogenesis

Dose (ul/kg bw)	Sampling Week	Population of treated cells	Number of abnormal sperm	Mean (% +/- SE)
Control	1	Spermatozoa	58	2.32 ± 0.89
8	1		85	3.4 ± 0.78
16	1		125	5.0 ± 0.68*
32	1		186	7.44 ± 0.9*
Control	3	Spermatid	63	2.57 ± 0.25
8	3		99	3.96 ± 0.48
16	3		139	5.56 ± 0.56*
32	3		209	8.36 ± 0.95*
Control	5	Pre-leptotene spermatogonia	56	2.24 ± 0.38
8	5		66	2.62 ± 0.45
16	5		72	2.88 ± 0.48
32	5		141	5.64 ± 0.58*

*         Significantly different from controls at P<0.05 in Student’s t test

Effect of crotonaldehyde treatment on the incidence of sperm abnormality in Swiss albine mice at different stages of spermatogenesis

Dose (ul/kg bw)	Sampling Week	Types and percentage of abnormal sperm heads
		Short hook	Without hook	Giant amorphous	Banana type
Control	1	0.48	0.6	0.24	1.0
8	1	0.88	1.68	0.48	0.36
16	1	1.04	2.16	0.88	0.92
32	1	1.28	1.68	2.2	2.28
Control	3	0.6	0.88	0.56	0.48
8	3	0.92	1.08	0.72	1.24
16	3	1.4	1.92	1.24	1
32	3	1.68	2.6	1.48	2.6
Control	5	0.6	0.8	0.2	0.64
8	5	0.52	0.88	0.4	0.84
16	5	0.48	1.08	0.56	0.76
32	5	1.12	1.6	1.4	1.52

Applicant's summary and conclusion

Conclusions:

Statistically significant increase in the percentage of abnormal sperm heads were recorded at 16 and 32 ul/kg bw at 3 weeks only and only at 32 ul/kg bw at 5 weeks.

Executive summary:

After single IP injection of male swiss albino mice with crotonaldehyde (8, 16 or 32 ul/kg bw) or vehicle (olive oil at 0.2 ml/kg bw) examinations of the number and percentage of abnormal sperm and different types of abnormal sperm heads were made after 1, 3 and 5 weeks. Animals treated with crotonaldehyde at 8, 16 and 32 ul/kg bw demonstrated a dose related increase in the percentage of abnormal sperm heads. Statistically significant increase in the percentage of abnormal sperm heads were recorded at 16 and 32 ul/kg bw at 3 weeks only and only at 32 ul/kg bw at 5 weeks. The common types of sperm head abnormalities recorded were short hooked, without hook, giant amorphous and banana type.