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Toxicological information

Carcinogenicity

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Description of key information

Based on results of the analogue n-butyl acrylate, tert-butyl acrylate is not anticipated to be carcinogenic in Spargue-Dawley rats via inhalation (doses up to 135 ppm (0.773 mg/L/day)). In addition, no evidence of carcinogenicity was found in a lifelong skin painting study with n-butyl acrylate in and in C4H/HeJ mice by dermal exposure at approx. 8 mg/kg bw.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
carcinogenicity, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please find the attached justification.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEC
Remarks:
rat inhalation
Effect level:
>= 0.773 mg/L air (analytical)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
histopathology: neoplastic
Remarks on result:
other: Result read-across source CAS No. 141-32-2.
Remarks:
Correction for molecular weight is not required.
Key result
Dose descriptor:
NOAEL
Remarks:
mice dermal
Effect level:
>= 8 mg/kg bw/day
Based on:
test mat.
Remarks:
applied 3 times a week
Sex:
male
Basis for effect level:
histopathology: neoplastic
Remarks on result:
other: Result read-across source CAS No. 141-32-2.
Remarks:
Correction for molecular weight is not required.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
773 mg/m³
Study duration:
chronic
Species:
rat
Quality of whole database:
Study performed equivalent to OECD 453 and under GLP conditions

Carcinogenicity: via dermal route

Link to relevant study records
Reference
Endpoint:
carcinogenicity, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please find the attached justification.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEC
Remarks:
rat inhalation
Effect level:
>= 0.773 mg/L air (analytical)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
histopathology: neoplastic
Remarks on result:
other: Result read-across source CAS No. 141-32-2.
Remarks:
Correction for molecular weight is not required.
Key result
Dose descriptor:
NOAEL
Remarks:
mice dermal
Effect level:
>= 8 mg/kg bw/day
Based on:
test mat.
Remarks:
applied 3 times a week
Sex:
male
Basis for effect level:
histopathology: neoplastic
Remarks on result:
other: Result read-across source CAS No. 141-32-2.
Remarks:
Correction for molecular weight is not required.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
8 mg/kg bw/day
Study duration:
chronic
Species:
mouse
Quality of whole database:
Acceptable study report which meets basic scientific principles and performed under GLP conditions.

Justification for classification or non-classification

Based on the available data, classification as a carcinogen is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and GHS classification (GHS UN rev.6, 2015).

Additional information

No adequate animal data are available and no epidemiological studies or case reports of tert-butyl acrylate were identified. However, data from the structural analogue n-butyl acrylate are available.

In a 2-year inhalation study, Sprague-Dawley rats were exposed by whole body exposure 6 hours per day, 5 days a week to 0, 15, 45 or 135 ppm (corresponding to approx. 0, 0.086, 0.258, 0.773 mg/L/day) n-butyl acrylate. During the first 13 weeks of the study, the concentrations were lower: 0, 5, 15 or 45 ppm. The post observation period was 6 months. n-Butyl acrylate showed no carcinogenic effect up to the highest concentration tested of 135 ppm (0.773 mg/L/day) (BASF 1985).

In addition, a lifetime dermal carcinogenesis study was conducted in mice. The dermal carcinogenic potential of n-butyl acrylate was assessed by applying 25 µL of a 1% (v/v) dilution in acetone (corresponding to approx. 8 mg/kg bw) to the backs of 40 male C3H/HeJ mice. A negative control group receiving acetone was dosed simultaneously. Both applications were performed three times a week throughout the lifetime of the animals. No biologically significant skin tumours were observed in the group tested with acetone or in the n-butyl acrylate group. No signs of skin irritation were observed in this study. No significant difference in mortality rate was observed between the treated group and the acetone control group. n-Butyl acrylate was not carcinogenic when applied to the skin of C3H/HeJ mice throughout their lifetime.