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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Carcinogenicity

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Administrative data

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.