Registration Dossier

Toxicological information

Specific investigations: other studies

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Administrative data

Endpoint:
biochemical or cellular interactions
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988
Reference Type:
publication
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Study of DNA adduct formation in vivo
GLP compliance:
no
Type of method:
in vivo
Endpoint addressed:
carcinogenicity

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Acrylic acid was 2,3-14C labelled. No further data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.1 M Na2HPO4
Details on exposure:
130 µl [2,3-14CJacrylic acid was dissolved in 1.9 ml 0.1 M Na2HP04 and the pH was adjusted about 5.5 with 0.2 ml 27% NaOH.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
once
Frequency of treatment:
single
Post exposure period:
24 h
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
233/ 257 mg/kg bw
Basis:
actual ingested
Remarks:
Doses / Concentrations:
7.9-8.7*10e9 dpm/kg bw
Basis:
actual ingested
No. of animals per sex per dose:
2
Control animals:
yes, concurrent vehicle

Results and discussion

Details on results:
No DNA adducts were detectable neither in the liver nor in the stomach.

Any other information on results incl. tables

Based on the limit of detection, a maximum possible DNA binding of AA will be at least 100,000 times below the DNA binding potency of the standard carcinogen aflatoxin B1.

Applicant's summary and conclusion