Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: rvaious
Type of information:
other: hazard assessment report
Adequacy of study:
supporting study
Study period:
-2004
Reliability:
other: reliable hazard assessment
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The literature search for the CERI hazard assessment was conducted in April 2002 with the databases including CAS online, HSDB, IRIS, RTECS ,TOXLINE etc. The references were updated when additional information on data source and others were obtained. In April 2004, the status of the risk assessment of acetaldehyde by international organizations was confirmed and any new studies that were critical to determine NOAEL/LOAEL were included in the references.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
other: hazard assessment
Title:
Hazard Assessment Report Acetaldehyde
Author:
Chemicals Evaluation and Research Institute (CERI), Japan
Year:
2007
Bibliographic source:
http://www.cerij.or.jp/ceri_en/hazard_assessment_report/yugai_indx_en.htm

Materials and methods

GLP compliance:
not specified
Type of assay:
other: various

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: various
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: various
Duration of treatment / exposure:
see Table 1
Frequency of treatment:
see Table 1
Post exposure period:
see Table 1
No. of animals per sex per dose:
see Table 1

Results and discussion

Any other information on results incl. tables

Table 1: Genotoxic potential of Acetaldehyde in in vivo genetoxicity assays

 

Test

Species (route)

Concentrationa

Results

Reference

Sex-linked

recessive lethal

Drosophila

melanogaster

(oral)

25,000 ppm

-

Woodruff et al., 1985

Sex-linked

recessive lethal

Drosophila melanogaster

(i.p.)

22,500 ppm

+

Woodruff et al., 1985

Micronucleus

Rat bone marrow cells (i.p.)

250 mg/kg

+

Wakata et al., 1998

Micronucleus

Rat peripheral blood

cells (i.p.)

250 mg/kg

+

Wakata et al., 1998

Micronucleus

CD-1 male mouse bone marrow cells (i.p.)

400 mg/kg

+

Morita et al., 1997

Micronucleus

C57BL/6J×C3H/He

mouse early spermatid (i.p.)

375 mg/kg

-

Lahdetie, 1988

Chromosomal

aberration

Rat embryo cells (Administration

through the amnion

(On gestation day 13)

7,800 mg/kg

+

Barilak &

Kozachuk,

1983

Sister chromatid

exchange

Male C3A mouse bone marrow cells (i.p.)

0.4 µg/animal

+

Obe et al.,

1979

Sister chromatid

exchange

Chinese hamster bone

marrow cells (i.p.)

0.5 mg/kg

+

Korte et al., 1981

Comet

Human lymphocyte (37°C,

1 hourtreatment)

3-100 mM

+

Blasiak

et al., 1999

DNA-protein

cross-links

Fischer 344 rat nasal mucosa (Inhalation

exposure,

6 hours/day,

5 days)

1,000 ppm

+

Lam et al.,

1986

Sperm

abnormality

C57BL/6J×C3H/He

mouse early spermatid (Intraperitoneal 5 times)

250 mg/kg

-

Lahdetie,

1988

a) When a single dose is described, it indicates the lowest positive concentration in the positive result and the highest negative concentration in the negative result.

 

Applicant's summary and conclusion

Conclusions:
Acetaldehyde showed genotoxic activity in vivo.
Executive summary:

Several in vivo experiments are reported for acetaldehyde. All experiments except those with spermatides and Drosophila melangogaster showed genotoxic activity.