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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
294 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC technical report No. 86
Overall assessment factor (AF):
6
Explanation for the modification of the dose descriptor starting point:
NOAEL from rat subacute developmental toxicity study for Exxal 8 is used to derive this DNEL since no inhalation study is available from the substance or from the degradation product.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Since the substance reacts during the use applications, hazard assessment of the substance is based on the most hazardous degradation product. No reliable study is available from the substance itself, so NOAEL from rat developmental study of the hazardous degradation product, Exxal 8; alcohols, C7 -9 -iso, C8 -rich, is used as starting point to derive following DNELs.

  

The assessment factors proposed by ECETOC (2003) were adopted when developing DNELs.

 

WORKERS

inhalation - systemic effects - long-term exposure

Relevant dose descriptor for the endpoint

NOAEL = 1 000 mg/kg bw/day for Exxal 8; developmental toxicity study, oral gavage, rat by ExxonMobil, 1995.

Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 3.

100% oral absorption regardless of species

100% inhalation absorption regardless of species

 

Corrected inhalatory NOAEC = oral NOAEL * (1/ sRV rat 8h) * (ABS oral-rat / ABS inh-human) * (sRV human / wRV)

ABS - absorption

sRVhuman - respiratory volume under standard conditions

wRV - respiratory volume light activity for worker

 

Corrected inhalatory NOAEC= 1000 * (1/0.38) * (100/100) * (6.7 / 10)

Corrected inhalatory NOAEC = 1763 mg/m3

Assessment factors – Based on ECETOC technical report No. 86

Intraspecies differences for workers                3

exposure duration - subchronic to chronic  2

Overall AF 3 * 2 = 6

 

DNEL chronic systemic inhalation= 1763 mg/m3 / 6 = 294 mg/m3

 

 

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

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