Hydrocarbons, C4

Toxicity to reproduction

Administrative data

Endpoint:

fertility, other

Remarks:

based on test type (migrated information)

Type of information:

other: EU Risk Assessment

Adequacy of study:

other information

Reliability:

other:

Data source

Reference

Reference 1

Reference Type:

other: EU Risk Assessment

Title:

European Union Risk Assessment Report 1,3-BUTADIENE, CAS No: 106-99-0, EINECS No:203-450-8

Author:

[ECB] European Chemicals Bureau

Year:

2002

Reference 2

Reference Type:

publication

Title:

Studies on the inhalation of 1,3-butadiene.

Author:

Carpenter, C.P. et al.

Year:

1944

Bibliographic source:

J Ind Hyg Toxicol 26; 69-78.

Reference 3

Reference Type:

study report

Title:

Unnamed

Year:

1988

Reference 4

Reference Type:

review article or handbook

Title:

Overview of reproductive and developmental toxicity studies of 1,3-butadiene in rodents.

Author:

Morrissey, R.E. et al.

Year:

1990

Bibliographic source:

Environ Health Persp. 86; 79-84.

Reference 5

Reference Type:

publication

Title:

Male-mediated F1 effects in mice exposed to 1,3-butadiene.

Author:

Anderson, D. et al.

Year:

1993

Bibliographic source:

In: Sorsa et al. (eds). Butadiene and styrene: Assessment of health hazards. IARC Scientific Publications. IARC: Lyon, France. pp 171-181.

Reference 6

Reference Type:

publication

Title:

Mutagenicity of 1,3-butadiene inhalation in somatic and germinal cells of mice.

Author:

Adler, I-D. et al.

Year:

1994

Bibliographic source:

Mutat Res. 309; 307-314.

Materials and methods

Principles of method if other than guideline:

EU Risk Assessment on the major component of C4 Hydrocarbons: 1,3-Butadiene

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Buta-1,3-diene

EC Number:

203-450-8

EC Name:

Buta-1,3-diene

Cas Number:

106-99-0

Molecular formula:

C4H6

IUPAC Name:

buta-1,3-diene

Details on test material:

- Name of test material (as cited in study report): 1,3-butadiene
- CAS number: 106-99-0
- EINECS number: 203-450-8

Test animals

Species:

other: rat, guinea pig, rabbit, mouse

Administration / exposure

Route of administration:

inhalation: gas

Details on mating procedure:

EU Risk Assessment on the major component of C4 Hydrocarbons: 1,3 -Butadiene

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

Rats, guinea pig, rabbits (Carpenter 1944): No conclusions can be drawn from these data.
Mice: There was no evidence to indicate an effect of exposure on fertility.

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

There are no adequate studies which assess the effect of butadiene on fertility. An early study is available but was poorly reported and used small numbers of animals (Carpenter et al., 1944). Rats, guinea pigs and rabbits were exposed to 0, 600, 2,300 or 6,700 ppm butadiene, 7.5 hours/day, 6 days/weeks for 8 months. In rats, the number of litters per female was reported to be slightly reduced in the exposed groups but because of inadequacies in the study, no conclusions can be drawn from these data. No effect on fertility has been seen in three dominant lethal studies in mice, reported in the section on mutagenicity. In the first of these studies, groups of 20 males were exposed to 0, 200, 1,000 or 5,000 ppm butadiene 6 hours/day for 5 days and then mated with unexposed females (Hackett et al., 1988b, summarised by Morissey et al., 1990). There was an indication from effects seen in the first 2 weeks post-exposure that butadiene may result in damage to the more mature sperm cells, spermatozoa and spermatids. However, the results were not conclusive. Similarly, no evidence for an effect on fertility was seen in a second dominant lethal study in mice, in which animals were exposed to butadiene either as a single exposure or in a repeated exposure regime (Anderson et al., 1993). In the single exposure protocol, groups of 25 male mice were exposed to 0 or 1,250 ppm while 50 male mice were exposed to 6,250 ppm butadiene for 6 hours. Animals were mated with unexposed females 5 days post-exposure. In the repeated exposure method, 25 males were exposed to 0 or 12.5 ppm while 50 mice were exposed to 1,250 ppm butadiene, 6 hours/day, 5 days/week for 10 weeks and then mated immediately with unexposed females. In the third study, conducted in (102/E1xC3H/E1)F1 mice, groups of 20 males were exposed to 0 or 1,300 ppm butadiene 6 hours/day for 5 days (Adler et al., 1994). At 4 hours after the last exposure each male was mated with pairs of unexposed females for a period of 4 weeks. There was no evidence to indicate an effect of exposure on fertility.

Applicant's summary and conclusion

Conclusions:

There was no evidence to indicate an effect of exposure on fertility.