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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
71.1 mg/m³
Most sensitive endpoint:
neurotoxicity
DNEL related information
Overall assessment factor (AF):
12.5
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:
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

1. Introduction:

In this chapter, all the endpoints from Aluminium ammonium (bis) sulfate are re-examined and analyzed in order to establish a DNEL (s)/DMEL (s) for each one of them if possible. The followed method is that proposed in the guidance for the implementation of Reach (Chapter R.8: Characterisation of dose (concentration)-response for human health, May 2008)

2. Classification in the Annex VI of CLP Regulation (Regulation (EC) N°1272/2008)

Aluminium ammonium (bis) sulfate is not classified according to the Directive 67/548/EC and the CLP Regulation..

 

3. DNELs/DMELs derivation according to the toxicological profile of Aluminium ammonium (bis) sulfate

Inhalation exposure was the most appropriate route for assessing occupational risk in workers. Dermal exposure is not considered as a relevant route of exposure since Aluminium ammonium (bis) sulfate is not likely to be systematically absorbed by dermal route (see §7.1).

Neither indications of carcinogenic nor reprotoxic potential were observed or expected. Tests assessing the mutagenic potential of Aluminium ammonium (bis)sulfatein vitroandin vivoprovided no evidence of mutagenic or genotoxic activity.

No acute toxicity hazard has been identified and no peak exposure has been predicted for Aluminium ammonium (bis)sulfate, therefore the long-term DNEL by inhalation route ensure a sufficient level of protection. No DNELacutefor inhalation route has been derived.

Calculation of long-term DNEL by inhalation for systemic effects for Aluminium / Worker

 

The concentration descriptor has been obtained from the combined toxicity study (OECD 426/452) by oral route (see § 7.9.1). Granulometry on the powder of Aluminium ammonium (bis)sulfate showed no detectable particles in the alveolar fraction and a very low percentage of total particulates in the inhalable fraction (<100 µm). These particles are expected to be dissolved by the mucus from the respiratory tract in order to be swalled. Consequently the toxicity by inhalation is warranted due to the potential for oral toxicity and no uncertainty factor is considered for the absorption between the oral route and the inhalation.

 

Under the test conditions of the chronic neurotoxicity study using Aluminium citrate (considered as a worst-case relevant aluminium salt), neuromuscular effects were observed on male and female rats. The NOAEL in this study is 30 mg Aluminium/kg bw/d.

 

The following Table 3.1 indicates the inhalation DNEL-long term for systemic effects calculation.

 

Table 3.1:Calculation of long-term DNEL by inhalation route for systemic effects

Worker

Long-term DNEL / inhalation / systemic effects

Step a : determination of the critical dose

Key study

Combined study OECD 426/452, K2 (read-across)

Relevant dose descriptor

NOAEL = 30 mg Al/kg bw/d (rat, oral) for neuromuscular effects (females and males)

Step b : Correct starting point – factor for uncertainties

Differences in absorption depending on route of exposure (route-route extrapolation, human/animal)

1

(oral absorption for aluminium sulfate /absorption by inhalation)

Modification for exposure

(experiment in animal and human)

1/0.38

(standard respiratory volume animal/human)

Modification for the respiratory volume

6.7/10

(respiratory rate difference under standard conditions and under conditions of light activity for 8 hours)

Correct starting point = relevant dose descriptor / overall factor for uncertainties

52.9 mg Al/m3

Step c : assessment factors

Interspecies differences

-      Differences in metabolic rate per b.w. (allometric scaling)

 

-      Remaining differences

 

 

 

-

(Not applicable)

 

2.5

Intraspecies differences

5

(worker)

Duration extrapolation

(sub-acute/sub-chronic/chronic)

1

(one-year repeated dose toxicity study)

Issues related to dose-response

1

Quality of the whole database

1

Overall assessment factor

12.5

DNEL calculation

4.23 mg Al/m3

71.1 mg salt/m3*

*Molecular Weightsalt=906.6 at 20°C

 

The inhalation DNEL long-term for systemic effects is 71.1 mg salt/m3in the worker. This value corresponds to an exposure of 4.23 mgAl/m3 which is already covered by the indicative occupationnal exposure level (IOEL) of 2 mg Al/m3used in many European countries.

1. Introduction:

In this chapter, all the endpoints from Aluminium ammonium (bis) sulfate are re-examined and analyzed in order to establish a DNEL (s)/DMEL (s) for each one of them if possible. The followed method is that proposed in the guidance for the implementation of Reach (Chapter R.8: Characterisation of dose (concentration)-response for human health, May 2008)

2. Classification in the Annex VI of CLP Regulation (Regulation (EC) N°1272/2008)

Aluminium ammonium (bis) sulfate is not classified according to the Directive 67/548/EC and the CLP Regulation..

 

3. DNELs/DMELs derivation according to the toxicological profile of Aluminium ammonium (bis) sulfate

Inhalation exposure was the most appropriate route for assessing occupational risk in workers. Dermal exposure is not considered as a relevant route of exposure since Aluminium ammonium (bis) sulfate is not likely to be systematically absorbed by dermal route (see §7.1).

Neither indications of carcinogenic nor reprotoxic potential were observed or expected. Tests assessing the mutagenic potential of Aluminium ammonium (bis)sulfatein vitroandin vivoprovided no evidence of mutagenic or genotoxic activity.

No acute toxicity hazard has been identified and no peak exposure has been predicted for Aluminium ammonium (bis)sulfate, therefore the long-term DNEL by inhalation route ensure a sufficient level of protection. No DNELacutefor inhalation route has been derived.

Calculation of long-term DNEL by inhalation for systemic effects for Aluminium / Worker

 

The concentration descriptor has been obtained from the combined toxicity study (OECD 426/452) by oral route (see § 7.9.1). Granulometry on the powder of Aluminium ammonium (bis)sulfate showed no detectable particles in the alveolar fraction and a very low percentage of total particulates in the inhalable fraction (<100 µm). These particles are expected to be dissolved by the mucus from the respiratory tract in order to be swalled. Consequently the toxicity by inhalation is warranted due to the potential for oral toxicity and no uncertainty factor is considered for the absorption between the oral route and the inhalation.

 

Under the test conditions of the chronic neurotoxicity study using Aluminium citrate (considered as a worst-case relevant aluminium salt), neuromuscular effects were observed on male and female rats. The NOAEL in this study is 30 mg Aluminium/kg bw/d.

 

The following Table 3.1 indicates the inhalation DNEL-long term for systemic effects calculation.

 

Table 3.1:Calculation of long-term DNEL by inhalation route for systemic effects

Worker

Long-term DNEL / inhalation / systemic effects

Step a : determination of the critical dose

Key study

Combined study OECD 426/452, K2 (read-across)

Relevant dose descriptor

NOAEL = 30 mg Al/kg bw/d (rat, oral) for neuromuscular effects (females and males)

Step b : Correct starting point – factor for uncertainties

Differences in absorption depending on route of exposure (route-route extrapolation, human/animal)

1

(oral absorption for aluminium sulfate /absorption by inhalation)

Modification for exposure

(experiment in animal and human)

1/0.38

(standard respiratory volume animal/human)

Modification for the respiratory volume

6.7/10

(respiratory rate difference under standard conditions and under conditions of light activity for 8 hours)

Correct starting point = relevant dose descriptor / overall factor for uncertainties

52.9 mg/m3

Step c : assessment factors

Interspecies differences

-      Differences in metabolic rate per b.w. (allometric scaling)

 

-      Remaining differences

 

 

 

-

(Not applicable)

 

2.5

(remaining differences)

Intraspecies differences

5

(worker)

Duration extrapolation

(sub-acute/sub-chronic/chronic)

1

(one-year repeated dose toxicity study)

Issues related to dose-response

1

Quality of the whole database

1

Overall assessment factor

12.5

DNEL calculation

4.23 mg Al/m3

71.1 mg salt/m3*

*Molecular Weightsalt=906.6 at 20°C

 

The inhalation DNEL long-term for systemic effects is 71.1 mg salt/m3in the worker. This value corresponds to an exposure of 4.23 mgAl/m3 which is already covered by the indicative occupationnal exposure level (IOEL) of 2 mg Al/m3used in many European countries.

(see GESTIS International Limit values: http://bgia-online.hvbg.de/LIMITVALUE/WebForm_ueliste.aspx)

 

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:
DNEL (Derived No Effect Level)
Value:
5.04 mg/kg bw/day
Most sensitive endpoint:
neurotoxicity
DNEL related information
Overall assessment factor (AF):
100
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

1. Introduction:

In this chapter, all the endpoints from Aluminium ammonium (bis)sulfate are re-examined and analyzed in order to establish a DNEL (s)/DMEL (s) for each one of them if possible. The followed method is that proposed in the guidance for the implementation of Reach (Chapter R.8: Characterisation of dose (concentration)-response for human health, May 2008)

2. Classification in the Annex VI of CLP Regulation (Regulation (EC) N°1272/2008)

Aluminium ammonium (bis)sulfate is not classified according to the Directive 67/548/EC and the CLP Regulation 1272/2008.

 

3. DNELs/DMELs derivation according to the toxicological profile of Aluminium ammonium (bis) sulfate

Oral exposure was the most appropriate route for assessing occupational risk for humans exposed via the environment. Inhalation exposure is warranted by the DNEL for oral exposure. Dermal exposure is not considered as a relevant route of exposure since Aluminium ammonium (bis)sulfate is not likely to be systematically absorbed by dermal route (see §7.1).

Neither indications of carcinogenic nor reprotoxic potential were observed or expected. Tests assessing the mutagenic potential of Aluminium ammonium (bis)sulfatein vitroandin vivoprovided no evidence of mutagenic or genotoxic activity.

No acute toxicity hazard has been identified and no peak exposure has been predicted for Aluminium ammonium (bis)sulfate, therefore the long-term DNEL by oral route ensure a sufficient level of protection. No DNELacutefor oral route has been derived.

Calculation of long-term DNEL by oral route for systemic effects for Aluminium /Humans exposed via the environment

The concentration descriptor has been obtained from the combined toxicity study (OECD 426/452) by oral route (see § 7.9.1).

 

Under the test conditions of the chronic neurotoxicity study of Aluminium citrate (considered as a worst-case relevant aluminium salt), neuromuscular effects were observed on male and female rats. The NOAEL in this study is 30 mg Aluminium/kg bw/d.

 

The following Table 3.1 indicates the oral DNEL-long term for systemic effects calculation.

 

Table 3.1:Calculation of long-term DNEL by oral route for systemic effects

Humans exposed via the environment

Long-term DNEL / oral / systemic effects

Step a :determination of the critical dose

Key study

Combined study OECD 426/452, K2 (read-across)

Relevant dose descriptor

NOAEL = 30 mg Al/kg bw/d (rat, oral) for neuromuscular effects (females and males)

Step b : Correct starting point – factor for uncertainties

Differences in absorption depending on route of exposure (route-route extrapolation, human/animal)

1

(same route of exposure ; same absorption between human and animal)

Modification for exposure

(experiment in animal and human)

-

Modification for the respiratory volume

Not applicable

Correct starting point = relevant dose descriptor / overall factor for uncertainties

30 mg Al/kg bw/d

Step c : assessment factors

Interspecies differences

-      Differences in metabolic rate per b.w. (allometric scaling)

 

-      Remaining differences

 

 

4

 

 

2.5

Intraspecies differences

10

(general population)

Duration extrapolation

(sub-acute/sub-chronic/chronic)

1

(one-year repeated dose toxicity study)

Issues related to dose-response

1

Quality of the whole database

1

Overall assessment factor

100

DNEL calculation

0.3 mg Al/kg bw/d

5.04 mg salt/kg bw/d*

*Molecular mass salt = 906.6 g/mol

The oral DNEL long-term for systemic effects is 5.04 mg Salt/kg bw/d for humans exposedviathe environment.