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Registration Dossier
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EC number: 931-252-8 | CAS number: 35238-34-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Subchronic inhalation toxicity study for Bisphenol A
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Dose descriptor starting point:
- NOAEC
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Rationale for DNEL derivation Bisphenol A (see also REACH registration for Bisphenol A):
Inhalation (systemic and local, long-term) – based on SCOEL assessment for Bisphenol A (13 week inhalation study)
SCOEL/SUM/113 (June 2014: "The inhalation NOAEC of 10 mg/m3 is taken as the starting point for recommending an OEL. The critical effect in this study was respiratory tract irritation. This value of 10 is divided by an assessment factor of 3 to cover the uncertainties related to the inter-species extrapolation in these local effects resulting in a recommended OEL of 3 mg/m3. Using the preferred value approach, 3 mg/m3 is rounded to 2 mg/m3. There are also some concerns about long-term systemic effects (liver and kidney effects), which may not have been fully addressed in this subchronic inhalation study. There is a 17–25-fold safety margin to the inhalation exposure levels of 34 and 49 mg/m3, which correspond to the BMDL10 of ~ 3.5 mg/kg bw (EFSA 2014) and to the NOAEL of 5 mg/kg bw observed for kidney and liver effects in oral studies. Because liver and kidney effects observed in oral long-term rodent studies were very mild even at the highest dose levels (50 mg/kg bw and 500/600 mg/kg bw, Tyl et al 2002 and 2008), this margin of safety is considered sufficient to cover extrapolation to long-term exposure, and also to cover possible remaining inter- and intra-species differences in toxicokinetics and toxicodynamics."
Inhalation (systemic and local, acute) – based on SCOEL assessment for Bisphenol A (13 week inhalation study)
SCOEL/SUM/113 (June 2014: "The inhalation NOAEC of 10 mg/m3 is taken as the starting point for recommending an OEL. The critical effect in this study was respiratory tract irritation. This value of 10 is divided by an assessment factor of 3 to cover the uncertainties related to the inter-species extrapolation in these local effects resulting in a recommended OEL of 3 mg/m3. Using the preferred value approach, 3 mg/m3 is rounded to 2 mg/m3. ....There is no toxicological basis for recommending an additional specific short-term exposure limit (STEL).” As a conservative approach short-term and long-term DNEL will be set at the same value; 2 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Subchronic inhalation toxicity study
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: following SCOEL Recommendation of 2014 for the main constituent Bisphenol A
- Dose descriptor starting point:
- NOAEC
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.008 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: following EFSA 2015 t-TDI (temporary-tolerable daily intake) definition for the main constituent Bisphenol A
- Modified dose descriptor starting point:
- other: human equivalent dose (HED)
- Explanation for the modification of the dose descriptor starting point:
t-TDI defined by EFSA in 2015
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.008 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ollowing EFSA 2015 t-TDI (temporary-tolerable daily intake) definition for the main constituent Bisphenol A
- Explanation for the modification of the dose descriptor starting point:
t-TDI defined by EFSA in 2015
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Rationale for DNEL derivation Bisphenol A (see also REACH registration for Bisphenol A, CAS-No. 80 -05 -7):
For explanation to inhalation and dermal exposure DNEL derivation Bisphenol A please see 'Additional Information - Workers'.
General Population oral (long-term and acute systemic) – based on EFSA Scientific Opinion of 2015 for Bisphenol A (multi-generation reproduction toxiciy studies in rats and mice)
EFSA reevaluated Bisphenol A and published a Scientific Opinion in 2015: “Bisphenol A was found to affect kidney and liver weight in parental animals and in all the generations of rats and mice examined in multi-generation studies. These effects were considered by EFSA (2006, 2010) as relevant systemic effects for the identification of a NOAEL. In mice the increased kidney weight was associated with nephropathy at the highest Bisphenol A dose. Liver weight was increased in rats (relative weight) and mice (both absolute and relative weight). The latter species also showed hepatocellular hypertrophy. The CEF Panel considered the endpoint “general toxicity” for hazard characterisation, using a reference point from the two-generation study in mice, which provided a BMDL10 for mean relative kidney weight of 8 960 μg/kg bw per day in male mice of the F0 generation.
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