Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
DNEL value:
220 mg/m³
Explanation for the modification of the dose descriptor starting point:
250 mg/kg bw/d * (1/0.38 * 50%/100% * 6.7/10) = 220 mg/m3
AF for dose response relationship:
1
Justification:
A clear NOAEL was derived from the study. No correction is required for dose reponse.
AF for differences in duration of exposure:
1
Justification:
A chronic study is used to set a chronic DNEL. No correction required.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required when correcting for inhalation starting point.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences.
AF for intraspecies differences:
5
Justification:
Default factor for workers.
AF for the quality of the whole database:
1
Justification:
Data is complete and of acceptable quality.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
250 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
DNEL value:
1 250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
250 mg/kg bw/d * (50/1) =12500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
A clear NOAEL was derived from the study. No correction is required for dose reponse.
AF for differences in duration of exposure:
1
Justification:
A chronic study is used to set a chronic DNEL. No correction required.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor extrapolating from rat to man.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences.
AF for intraspecies differences:
5
Justification:
Default factor for workers.
AF for the quality of the whole database:
1
Justification:
Data is complete and of acceptable quality.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

TBBPA is not acutely toxic via the oral, inhalation or dermal routes; neither is TBBPA an irritant to the skin or eye, or a skin sensitiser, and in the absence of relevant local effects in chronic toxicity studies derivation of acute DNEL values for toxicity or long-term local effects is not appropriate.

TBBPA’s NOAEL in a 2 year oral rat chronic toxicity and carcinogenicity study was 250 mg/kg/d and was used to derive long-term systemic DNEL values. Mechanistic considerations, and the absence of any genotoxic response, showed the tumours observed in the study were not threshold related and DNELs rather than DMELs could be set.

The material was not toxic to reproduction or a developmental toxin.

Correction factors for inhalation and dermal NOAEL values derived from the oral NOAEL were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose[concentration]-response for human health", and used the methods and equations therein.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.3 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
DNEL value:
109 mg/m³
Explanation for the modification of the dose descriptor starting point:
250 mg/kg bw/d * (1/1.15 * 50%/100% ) = 109 mg/m3
AF for dose response relationship:
1
Justification:
A clear NOAEL was derived from the study. No correction is required for dose reponse.
AF for differences in duration of exposure:
1
Justification:
A chronic study is used to set a chronic DNEL. No correction required.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required when correcting for inhalation starting point.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
Default factor for general population.
AF for the quality of the whole database:
1
Justification:
Data is complete and of acceptable quality.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
DNEL value:
12 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
250 mg/kg bw/d * (50/1) =12500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
A clear NOAEL was derived from the study. No correction is required for dose reponse.
AF for differences in duration of exposure:
1
Justification:
A chronic study is used to set a chronic DNEL. No correction required.
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric factor when extrapolating from rat to man.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
Default factor for the general population.
AF for the quality of the whole database:
1
Justification:
Data is complete and of acceptable quality.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
DNEL value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
None required
AF for dose response relationship:
1
Justification:
A clear NOAEL was derived from the study. No correction is required for dose reponse.
AF for differences in duration of exposure:
1
Justification:
A chronic study is used to set a chronic DNEL. No correction required.
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric factor when extrapolating from rat to man.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
Default factor for workers.
AF for the quality of the whole database:
1
Justification:
Data is complete and of acceptable quality.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

TBBPA is not sold to the general population.

TBBPA is not acutely toxic via the oral, inhalation or dermal routes; neither is TBBPA an irritant to the skin or eye, or a skin sensitiser, and in the absence of relevant local effects in chronic toxicity studies, derivation of acute DNEL values for toxicity or long-term local effects is not appropriate.

TBBPA’s NOAEL in a 2 yearoral ratchronic toxicity and carcinogenicity study was 250 mg/kg/d and was used to derive long-term systemic DNEL values. Mechanistic considerations, and the absence of any genotoxic response, showed the tumours observed in the study were not threshold related and DNELs rather than DMELs could be set.

The material was not toxic to reproduction or a developmental toxin.

Correction factors for inhalation and dermal NOAEL values derived from the oral NOAEL were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose[concentration]-response for human health", and used the methods and equations therein.