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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
until 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
These data based on the International Programme on Chemical Safety (IPCS) published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organisation (Environmental Health Criteria 167).

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Not indicated.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetaldehyde
EC Number:
200-836-8
EC Name:
Acetaldehyde
Cas Number:
75-07-0
Molecular formula:
C2H4O
IUPAC Name:
acetaldehyde
Constituent 2
Reference substance name:
AB 1925000
IUPAC Name:
AB 1925000
Details on test material:
Purity: ca. 99%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Doses:
25 mg/kg bw,
125mg/kg bw
675 mg/kg bw
No. of animals per sex per dose:
10 males and 10 females per dose
20 males and 20 females control group
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: NOEL
Effect level:
125 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
other: LOEL
Effect level:
675 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Administration of the highest dose in drinking -water of 675 mg acetaldehyde/kg bw to Wistar rats resulted in slight to moderate focal hyperkeratosis of the forestomach in 8/10 males and 8/10 females. No effect were observed at lower dose levels of 25 and 125 mg/kg bw. In the control group, very slight focal hyperkeratosis of the forestomach was noted in 6/20 females and 3/20 males (1/20 slight). At the top dose (675 mg/kg), relative kidney weights were slightly increased in males, urinary production was decreased, and there were variations in serum biochemistry, most of which were attributable to reduced water intake. There were no effects in the liver.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The no-observed-effect level (NOEL) in Wistar rats was 125 mg/kg bw, the lowest-observed-effect level (LOEL) was 675 mg/kg (Til et al., 1988).
Executive summary:

The data based on the International Programme on Chemical Safety (IPCS) published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organisation (Environmental Health Criteria 167). Acetaldehyde was oral administered to Wistar rats in drinking-water, daily for four weeks.

At the top dose (675 mg/kg), relative kidney weights were slightly increased in males, urinary production was decreased, and there were variations in serum biochemistry, most of which were attributable to reduced water intake. There were no effects in the liver.

Therefore, the no-observed-effect level (NOEL) in Wistar rats was 125 mg/kg bw, the lowest-observed-effect level (LOEL) was 675 mg/kg (Til et al., 1988).