Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
53.6 mg/m³
Most sensitive endpoint:
acute toxicity
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
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:
medium hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
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:
medium 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:
DNEL (Derived No Effect Level)
Value:
8.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
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:
medium hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal 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
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
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:
medium hazard (no threshold derived)

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
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

There are no dermal toxicity studies available for the aromatic sulfonic acids. The dermal toxicity studies for the chemically similar hydrotropes only local effects were observed. The derivation of systemic DNEL's for all exposure routes will therefore be based on oral exposure with adjustments made per OECD guidelines. The starting point was a 500 mg/kg bw/day NOAEL in a rat 28-day repeat dose study with oral exposure. An overall assessment factor of 200 was derived combining a factor of 10 (interspecies), 10 (intraspecies, general population) and 2 (exposure duration subchronic to chronic). The resulting dermal DNEL for the general population is 2.5 mg/kg bw/day. The same valule is used for the oral DNEL.

The general population inhalation starting point was the same study with a NOAEL of 500 mg/kg bw/day. The corrected NOAEC was calculated according to the RIP documents, considering allometric scaling, standard respiratory volume and exposure duration.

The standard respiratory volume of rats is 0.2 L/min/rat = 0.8L/min/kg assuming a standard rat is 250g.

0.38 m3/kg bw in 8 hours

1.15 m3/kg bw in 24 hours

The standard respiratory volume of humans is 0.2L/min/kg bw

The allometric scaling factor is 4 and the standard bw of a human = 70 kg

6.7 m3/person in 8 hours

20 m3/person in 24 hours

10 m3/worker in 8 hours (light work)

In oral studies, a 24h/d exposure period is assumed. For the route-to-route extrapolation (i.e., oral to inhalation), the oral dose is calculated as concentration in air, considering the standard respiratory volume. It is assumed that both oral absorption and inhalation absorption = 100%.

Corrected NOAEC(24h) = oral NOAEL/standard respiratory volume(24h)

= 500 mg/kg bw/d divided by 1.15 m3/kg bw

= 435 mg/m3

The corrected NOAEC of 435 mg/m3 is divided by an assessment factor of 50 (based on 2.5 for interspecies and remaining differences, 10 for intraspecies, and 2 for exposure duration of subchronic to chronic).

The resulting DNEL inhalation = 8.7 mg/m3