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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.3 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):
50
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763.2 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 = 1763.2 mg/m3.

AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for differences in duration of exposure:
4
Justification:
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) was carried out with an administration period for Males, 42 days and Females approximately 54 days (from 14 days before mating to day 4 of lactation (Satellite group for the recovery of females, 42 days)) which is between subabcute and subchronic. Therefore, an AF of 4 instead 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
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 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):
200
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 Fatty acids, coco esters with oxybis(propanediol) 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 low water solubility, the high molecular weight (>350) and the log Pow value implies that dermal uptake of Fatty acids, coco esters with oxybis(propanediol) 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:
4
Justification:
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) was carried out with an administration period for Males, 42 days and Females approximately 54 days (from 14 days before mating to day 4 of lactation (Satellite group for the recovery of females, 42 days)) which is between subabcute and subchronic. Therefore, an AF of 4 instead of 6 (subacute to chronic) should be used.
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:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
8.696 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):
100
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
869.6 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) = 869.6 mg/m3.

AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for differences in duration of exposure:
4
Justification:
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) was carried out with an administration period for Males, 42 days and Females approximately 54 days (from 14 days before mating to day 4 of lactation (Satellite group for the recovery of females, 42 days)) which is between subabcute and subchronic. Therefore, an AF of 4 instead 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:
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:
25 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):
400
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 Fatty acids, coco esters with oxybis(propanediol)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 low water solubility, the high molecular weight (>350) and the log Pow value implies that dermal uptake of Fatty acids, coco esters with oxybis(propanediol)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:
4
Justification:
A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) was carried out with an administration period for Males, 42 days and Females approximately 54 days (from 14 days before mating to day 4 of lactation (Satellite group for the recovery of females, 42 days)) which is between subabcute and subchronic. Therefore, an AF of 4 instead of 6 (subacute to chronic) should be used.
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:
medium hazard (no threshold derived)
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:
25 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):
400
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:

A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) was carried out with an administration period for Males, 42 days and Females approximately 54 days (from 14 days before mating to day 4 of lactation (Satellite group for the recovery of females, 42 days)) which is between subabcute and subchronic. Therefore, an AF of 4 instead of 6 (subacute to chronic) should be used.

AF for dose response relationship:
1
Justification:
Default value (ECHA)
AF for differences in duration of exposure:
4
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

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