Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
410.89 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
data from oral exposure is applicable for potential effects that might occur following exposure by inhalation
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:
76.75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
data from oral exposure is applicable for potential effects that might occur following dermal penetration
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

Workers

Chapter 8 of the reach TGD (Appendix R.8 -8) indicates that acute exposure DNEL values are not normally required. Additionally, the lack of acute oral or dermal toxicity would indicate that SAIB is non-hazardous under acute exposure scenarios. It is assumed also that there will be no acute or long-term oral exposures to SAIB in worker populations. Eye and respiratory irritation thresholds are assumed to exceed thresholds for chronic systemic effects.    

                        

Long-term inhalation, systemic

A 1-year chronic oral toxicity study gave a NOEL of 1000 mg/kg. Extrapolating from oral toxicity inhalation, the NOEL first must be converted to mg/m3by dividing by a factor of 0.38, and then corrected for oral bioavailability (50%) by multiplying by a factor of 2. Further corrections are then necessary to convert from the 6 hour daily exposure to an 8 hour per day exposure (0.75), correction for 7-day experimental exposure to 5-day work week (1.4) and to adjusted for respiration for light work (0.67). ECETOC Assessment factors were applied, which consisted of intraspecies (3) and interspecies (4), for a total of 12.

     

- Converting mg/kg to mg/m3= 1000/0.38 = 2630.16 mg/m3

- Correcting for oral bioavailability = 2630.16*2 = 5260.32 mg/m3

- Correcting for 7-day experimental exposure to 5-day work week, and light work= 526.32 mg/m3* (1.4) *(0.67) = 4930.69 mg/m3

- Application of adjustment factors: 4930.69 mg/m3/12 =410.89 mg/m3

Long-term dermal, systemic

A 1-year chronic oral toxicity study gave a NOEL of 1000 mg/kg. Extrapolating from oral to dermal, the NOEL first must be corrected to convert from the 6 hour daily exposure to an 8 hour per day exposure (0.75), and correction for 7-day experimental exposure to 5-day work week (1.4) and to adjusted for respiration for light work (0.67). ECETOC Assessment factors were applied, which consisted of intraspecies (3) and interspecies (4), for a total of 12.

 

- Correcting for 7-day experimental exposure to 5-day work week, and light work = 1000 mg/kg*(1.4)*(0.67) = 920.96 mg/kg

- Application of adjustment factors: 920.96 mg/kg/12 =76.75 mg/kg

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
86.55 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
data from oral exposure is applicable for potential effects that might occur following exposure by inhalation
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:
50 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Explanation for the modification of the dose descriptor starting point:
data from oral exposure is applicable for potential effects that might occur following dermal penetration
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:
50 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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

General Population

Chapter 8 of the reach TGD (Appendix R.8 -8) indicates that acute exposure DNEL values are not normally required. Additionally, the lack of acute oral or dermal toxicity would indicate that SAIB is non-hazardous under acute exposure scenarios. It is assumed also that there will be no acute oral exposures to SAIB in general populations. Eye and respiratory irritation thresholds are assumed to exceed thresholds for chronic systemic effects.

                          

Long-term inhalation, systemic

A 1-year chronic oral toxicity study gave a NOEL of 1000 mg/kg. Extrapolating from oral to inhalation exposure, the NOEL first must be converted to mg/m3by dividing by a factor of 1.15, and then corrected for oral bioavailability (50%) by multiplying by a factor of 2. ECETOC Assessment factors were applied, which consisted of intraspecies (5), for interspecies (4), for a total of 20.   

 - Converting mg/kg to mg/m3= 1000/1.15 = 860.96 mg/m3

- Correcting for oral bioavailability = 860.96*2 = 1730.91 mg/m3

- Application of adjustment factors – 1730.91 mg/m3/20 =86.55 mg/m3

Long-term dermal, systemic

A 1-year chronic oral toxicity study gave a NOEL of 1000 mg/kg.  ECETOC Assessment factors were applied, which consisted of intraspecies (5) and interspecies (4), for a total of 20.

- Application of adjustment factors: 1000 mg/kg/20 =50.0 mg/kg

Long-term oral, systemic

A 1-year chronic oral toxicity study gave a NOEL of 1000 mg/kg. ECETOC Assessment factors were applied, which consisted of intraspecies (5) and interspecies (4), for a total of 20.

- Application of adjustment factors: 1000 mg/kg/20 =50.0 mg/kg