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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian germ cell study: gene mutation
Remarks:
Type of genotoxicity: gene mutation
Type of information:
other: Experimental study with acrylic acid (structural analogue) which is used for read-across (see attached read across justification document in IUCLID section 13)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Sufficiently documented and scientifically acceptable study. Justification for read-across: similar chemical structure (see Cemical Safety Report)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster)
Deviations:
yes
Remarks:
no data on quality assurance
GLP compliance:
not specified
Type of assay:
Drosophila SLRL assay

Test material

Constituent 1
Reference substance name:
acrylic acid
EC Number:
201-177-9
Cas Number:
79-10-7
IUPAC Name:
acrylic acid
Test material form:
other: liqid
Details on test material:
- Name of test material: Acrylic acid
- Physical state: liquid
- Analytical purity: >99.8%
obtained from Hoechst Celanese Company (Sommerville, NJ, USA)

Test animals

Species:
Drosophila melanogaster
Strain:
other: males: Canton-S wild type stock, females: balancer stock "Basc"
Sex:
male

Administration / exposure

Route of administration:
oral: feed
Vehicle:
5% sucrose solution at pH6
Details on exposure:
1-day-old males, previously starved for 4 hr, were treated in groups of 15 in shell vials (23 x 90 mm) plugged with rayon-fibre balls. The base of each vial was covered with two discs of glass-fibre filter material (SP141) on which was pipetted approximately 1.0 ml of feeding solution containing 2% acrylic acid. Daily for 3 days, the males were transferred to new treatment vials with freshly prepared feeding solution.
Duration of treatment / exposure:
3 days
Frequency of treatment:
continously
Doses / concentrations
Remarks:
Doses / Concentrations:
2 %
Basis:
other: nominal in 5% sucrose solution at pH 6
Positive control(s):
100 ppm NDMA in 5% sucrose for 24 hr.

Examinations

Evaluation criteria:
lethality

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The Drosophila sex-linked recessive lethal assay is an in vivo mutation assay. In this assay acrylic acid was not mutagenic after oral exposition over 3 days.
Executive summary:

Acrylic acid was tested for induction of sex-linked recessive lethals in Drosophila melanogaster by feeding route. A primary study had established 2% acrylic acid in a 5% sucrose solution at pH 6 as the maximal ingestion level. After 3 days of ingestion of acrylic acid, one lethal was observed in 9070 progeny, in comparison with 5 lethals in 10501 progeny of control males. The mutation frequency after ingestion of acrylic acid was less than concurrent controls in the feeding study.

Therefore it can be concluded with a high degree of confidence that acrylic acid is not mutagenic in this in vivo mutation assay.

This result can be extrapolated to magnesium acrylate.

Please refer to the justification for read across in the Chemical Safety Report.