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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.08 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
17
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Discussion-workers

DNELs for workers[1]

Exposure pattern

Route

Descriptors[2]

DNEL/DMEL (appropriate unit)

Most sensitive endpoint

Long-term - systemic effects

Oral (mg/kg bw /day)

Not relevant

Not relevant

Not relevant

Dermal (mg/kg bw /day)

DNEL

3.08 mg/kg bw/day (215.6 mg/day)

Thyroids follicular hyperactivity

Inhalation (mg/m3)

DNEL

5.0 mg/m3(50 mg/day)

Thyroids follicular hyperactivity

 

DNEL-inhalation

DNELacute

A Worker-DNEL-acutefor the inhalatory route has not been derived.

 

Chapter R8 of the “guidance on information requirements and chemical safety assessment” states “A DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures, for instance when sampling or connecting/disconnecting vessels.This is most relevant for workers exposed to high peak concentrations of volatile and toxic substances”

 

Sodium chlorate is not classified for acute inhalation toxicity. No effects were observed in an acute inhalation toxicity study.

 

The vapour pressure is extremely low and thus does not present any potential for inhalation exposure due to volatilization. Furthermore the particle size distribution for sodium chlorate as it is produced shows that 96.35% of the sodium chlorate particles has a diameter >150 µm. Inhalable dust that can reach the upper airways (nose, throat) has a particle diameter < 100 µm and inhalable dust that reaches the lower airways (lungs )has a particle diameter between 5-10 µm.

An acute inhalation study shows no toxicity at the maximizing particle size distribution (1.42 mg/L, MMAD 2.2) or chamber concentration (5.59 mg/L, MMAD 3.0).

 

Finally high peak exposures do not occur during the manufacturing or use of sodium chlorate.

DNELlongterm

A Worker-DNEL-longtermfor the inhalatory route has been derived. The critical DNEL is 5.0 mg/m3.

 

DNEL-dermal

DNELacute

A Worker-DNEL-acutefor the dermal route has not been derived.

Chapter R8 of the “guidance on information requirements and chemical safety assessment” states “A DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures, for instance when sampling or connecting/disconnecting vessels.This is most relevant for workers exposed to high peak concentrations of volatile and toxic substances”

 

Sodium chlorate is not classified for acute dermal toxicity. No effects were observed in an acute dermal toxicity study. Furthermore an in vitro dermal penetration study showed that that the dermal adsorption of sodium chlorate is low, 0.51% and 1.85% of a 5 mg/m2and a 150 µg/m2dose, respectively.

 

Finallyhigh peak exposures do not occur during the manufacturing or use of sodium chlorate.

DNELlongterm

A Worker-DNEL-longtermfor the dermal route been derived. The critical DNEL is 3.08 mg/kg bw/day.

 

DNEL-oral

Deriving aDNELfor the oral route is not relevant for workers(R8 p.55).


[1]As the respiration rate is taken into account for the derivation of the DNEL, this table need to be repeated in case different exposure scenarios lead to different respiration rate.

[2]Values inare DNEL/DMEL/ not quantifiable

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Discussion-general population

DN(M)ELs for general population[1]

Exposure pattern

Route

Descriptors[2]

DNEL/DMEL (appropriate unit)

Most sensitive endpoint

Long-term - systemic effects

Oral (mg/kg bw /day)

DNEL

0.05 mg/kg bw/day (3.0 mg/day)

Thyroid follicular cell hypertrophy

DNELacute

 

Chapter R8 of the “guidance on information requirements and chemical safety assessment” states “A DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures, for instance when sampling or connecting/disconnecting vessels.This is most relevant for workers exposed to high peak concentrations of volatile and toxic substances”

 

The substance is not available in consumer available products. However release into the environment is possible. However this will not lead to high peak exposures of the general public. Therefore aDNELacuteis not derived for the general public.

 

DNELlongterm

Considering the exposure pattern of sodium chlorate consumers are not exposed to sodium chlorate via the use described in section 2. The substance is not available in or released from in consumer availableproducts[a1] . However release into theenvironment is possible[a2] . The major route of environmental exposure of humans to chlorate is through drinking-water (WHO, 2005). Therefore a specific oralDNELlongtermis derived for the general population.

[1]As the respiration rate is taken into account for the derivation of the DNEL, this table need to be repeated in case different exposure scenarios lead to different respiration rate.

[2]Values inare DNEL/DMEL/ not quantifiable