Carbonic acid, diphenyl ester, reaction products with bisphenol A

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary literature: EU Risk Assessment Report Bisphenol A (review)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

4,4'-Isopropylidenediphenol (Bisphenol A) (CAS-No. 108-95-2)

Author:

European Chemicals Bureau (ECB)

Year:

2003

Bibliographic source:

EU Risk Assessment Report, 3rd Priority List, Volume 37

Reference 2

Reference Type:

publication

Title:

4,4´-Isopropylidenediphenol (bisphenol-A)

Author:

European Chemicals Bureau (ECB)

Year:

2008

Bibliographic source:

EU Risk Assessment Report, Human Health Addendum of April 2008 (to be read in conjunction with published EU RAR of BPA, 2003)

Reference 3

Reference Type:

other company data

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-isopropylidenediphenol

EC Number:

201-245-8

EC Name:

4,4'-isopropylidenediphenol

Cas Number:

80-05-7

Molecular formula:

C15H16O2

IUPAC Name:

2,2-bis(4-hydroxyphenyl)propane

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Executive summary:

The 2003 EU RAR concluded:

"No useful information on the effects of repeated exposure to BPA in humans is available, but experimental studies in rats, mice, and dogs are available. In rat inhalation studies, the principal effect of repeated exposure was the same as observed following a single exposure: slight upper respiratory tract epithelium inflammation, with a NOAEC of 10 mg/m³and a LOAEC of 50 mg/m³. Dietary studies in rats have reported reductions in reproductive organ weights and testicular toxicity at 235 mg/kg and a NOAEL of 74 mg/kg was established in a two-year study based on marginal effects on body weight gain at the next dose level of 148 mg/kg. In mice, the LOAELs of 120 mg/kg in males for multinuclear giant hepatocytes and 650 mg/kg in females for a reduction in body weight gain of unknown magnitude were identifed in a two-year study. There are no animal data available for repeated dermal exposure."

The 2008 updated EU RAR concluded:

"Oral studies in rats and mice have shown that the repeated dose toxicity of BPA involve[s] effects on bodyweight gain, liver and kidney. A NOAEL of 50 mg/kg/day has been identified in a recent 2-generation study in mice for these effects. This NOAEL rather than the original NOAEL of 120 mg/kg/day for liver effects from the published report is taken forward to the risk characterisation."

There is no reliable and significant new information on repeated dose toxicity of Bisphenol A.

Bisphenol A is included in Annex 1 of Regulation 67/548/EEC and Annex VI of Regulation (EC) No 1272/2008. No classification regarding repeated dose toxicity is required.