Registration Dossier
Registration Dossier
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EC number: 701-404-6 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.705 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 60 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The toxicity of 4,4- Isopropylidenediphenol, Oligomeric reaction products with 1-Chloro-2,3-Epoxypropane reaction products with Ethylene Diamine
was investigated with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996). This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 60 mg/kg bw/day.
The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 60 mg/kg bw/day.
Since only a sub-chronic oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation routes. According to Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, it is proposed in the absence of route specific information on the starting route, to include a default factor of 2 in the case of oral-inhalation extrapolation. On the assumption, that in general, dermal absorption will not be higher than oral absorption, no default factor is introduced for the oral to dermal extrapolation. The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation.
This approach will be taken forward to DNEL derivation.
60/2 (absorption rate) / 0.38 m3/kg bw = Inhalation NOAEL Rat of 78.9 mg/m3 (8h)
NOAEC = 78.9 x 0.67 = 52.9 mg/m3
- Justification:
- Assessment factor for dose response is not required
- AF for differences in duration of exposure:
- 6
- Justification:
- Assessment factor of two included due to extrapolation from a sub-acute to chronic endpoint
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- sRV is used for converting the oral dose into respiratory concentration for rat (route-to-route extrapolation), the allometric scaling factor is already taken into account
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill.)
- AF for the quality of the whole database:
- 1
- Justification:
- Study conducted to GLP Standards and international OECD guidelines
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:
- 0.28 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 60 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 84 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The toxicity of BADGE-EDA was
investigated with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996). This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 60 mg/kg bw/day.
The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 60 mg/kg bw/day.
The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation. This approach will be taken forward to DNEL derivation.
- Justification:
- Assessment factor for dose response not required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Assessment factor of two included due to extrapolation from a sub-chronic to chronic endpoint
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default, to correct for differences in metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences, i.e.
toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part). As described in R.8.4.3.1 Assessment factors relating to the extrapolation procedure of the REACH Guidance - AF for other interspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill.
- AF for intraspecies differences:
- 4
- Justification:
- Assuming body weight of rat 0.250 kg an allometric scaling factor of 4 is applied based on the assumed Human weight of 70 kg (as detailed in Table R8-3 of REACH Guidance on information requirements and chemical safety assessment)
- AF for the quality of the whole database:
- 1
- Justification:
- Study conducted to GLP Standards and international OECD guidelines
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The substance is not intended to be marketed for consumer use.
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