Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 500-303-2 | CAS number: 115340-85-7 1 - 4.5 moles ethoxylated
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.51 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point was corrected according to Figure R.8-3 in chapter R.8 in the ECHA guidance document (version 2.1, November 2012). NOAEL (oral, rat) = 1000 mg/kg bw/day => NOAEC (corrected, inhalation) = NOAEL(oral, rat) x 1/(0.38 m3/kg bw/day) x 6.7 m3/10 m3 x 0.5 = 1763.16 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default value (ECHA)
- AF for differences in duration of exposure:
- 6
- Justification:
- An oral Repeated Dose Toxicity Study (OECD 407) was carried out with an administration period of 28 days. Therefore, an AF of 6 (subacute to chronic) should be used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 5
- Justification:
- Default value (ECHA)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value (ECHA)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
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:
- 33.3 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:
- 1 000 mg/kg bw/day
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In an acute dermal toxicity study with Sprague-Dawley rats the LD50 of 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco was determined to be > 2000 mg/kg. No signs of systemic toxicity were observed, indicating primarily a low dermal toxicity. Overall, due to the experimental low dermal toxicity, the water insolubility, the high molecular weight (>538) and the log Pow value implies that dermal uptake of 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco in humans is considered as very low. The potential risk of any uptake would be low as the substance is not irritating to the skin.
According to QSAR DERMWIN the calculated dermal absorption is 10 %. Therefore, the starting point was corrected according to the low absorption through skin.
- AF for dose response relationship:
- 1
- Justification:
- Default value (ECHA)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value (ECHA): an AF of 6 (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 5
- Justification:
- Default value (ECHA)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value (ECHA)
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting point was corrected according to Figure R.8-3 in chapter R.8 in the ECHA guidance document (version 2.1, November 2012). NOAEL (oral, rat) = 1000 mg/kg bw/day => NOAEC (corrected, inhalation) = NOAEL (oral, rat) x 1/(1.15 m3/kg bw/day) = 870 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default value (ECHA)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value (ECHA)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 10
- Justification:
- Default value (ECHA)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value (ECHA)
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:
- 16.7 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In an acute dermal toxicity study with Sprague-Dawley rats the LD50 of 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco was determined to be > 2000 mg/kg. No signs of systemic toxicity were observed, indicating primarily a low dermal toxicity. Overall, due to the experimental low dermal toxicity, the water insolubility, the high molecular weight (>538) and the log Pow value implies that dermal uptake of 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco in humans is considered as very low. The potential risk of any uptake would be low as the substance is not irritating to the skin.
According to QSAR DERMWIN the calculated dermal absorption is 10 %. Therefore, the starting point was corrected according to the low absorption through skin.
- AF for dose response relationship:
- 1
- Justification:
- Default value (ECHA)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value (ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 10
- Justification:
- Default value (ECHA)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value (ECHA)
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default value (ECHA)
- AF for dose response relationship:
- 1
- Justification:
- Default value (ECHA)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value (ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value (ECHA)
- AF for intraspecies differences:
- 10
- Justification:
- Default value (ECHA)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value (ECHA)
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
