Registration Dossier
Registration Dossier
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EC number: 914-309-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 3
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 59 µg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
- long-term DNELs:
- Skin sensitization:
- Carcinogenicity:
- Reproductive (developmental) toxicity:
DNELS for workers
No acute DNELs were calculated. Although the substance is classified for acute oral and inhalation toxicity, no high peak of exposure was expected.
DNEL derivation was performed following the method proposed in the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
Although physico-chemical data tend to indicate that PBN1 mixture is a non reactive inert substance and that its size and structure can not allow its absorption by skin or airway, a worst case approach has been chosen by considering the data for nickel chloride and nickel fluoride contained at a content of 4.5 and 9.5% respectively in PBN1 mixture.
Inhalation route:
The SCOEL has derived an 8 hour TWA for nickel and nickel compounds (SCOEL/SUM/85, May 2009 for public consultation) of 0.01 mg/m3. This value is based on protection from inflammatory effects in the lung but according to available evidence should also protect against carcinogenic effects.
As Ni is contains up to 7% in PBN1 mixture the long-term toxicity DNEL for inhalation of the substance is 0.14 mg/m3.
Oral route:No long-term toxicity DNEL will be derived as it is not a relevant route for workers.
Dermal route:
The 2-year oral carcinogenicity study in rats (CRL, 2007, Klimisch 1), where the dose of 2.2 mg/kg/day (expressed as Ni) was a NOAEL, was selected for DNEL derivation, using a route-to-route extrapolation. The relevant systemic effect considered is the reduction in body weight. This effect was considered to bear a threshold mode of action.
- Modification of the starting point:
An oral-to-dermal route extrapolation was applied, considering 100% absorption by both routes of exposure as the worst case in the absence of specific data.
Corrected NOAEL (dermal) for workers (over 5 working days per week) = 2.2 x 7/5 = 3.1 mg/kg/day
- Assessment factors:
The following assessment factors were applied:
• Interspecies differences (mainly toxicokinetic): 4 (default value for rats)
• Remaining interspecies differences (mainly toxicodynamic): 2.5 (default value)
• Intraspecies differences: 5 (default value for workers)
• Differences in duration of exposure: 1 (chronic animal data)
• Issues related to severity and dose-response: 1 (because of the use of NOAEL as a starting point)
• Quality of whole database: 1 (reliability 1 study)
Global assessment factor (workers) = 4 x 2.5 x 5 x 1 x 1 x 1 = 50
- DNEL calculation:
DNEL (workers, dermal, long-term, systemic effects) = 3.1 / 50 = 62 µg Ni/kg/day = 886 µg PBN1/kg/day
This value being higher than the dermal DNEL for skin sensitization, the latter is reported above.
It is not possible to set a scientifically based threshold for skin elicitation and sensitisation caused by nickel salts after direct and prolonged exposure. For use in the risk characterisation of occupational exposure, the empirical elicitation threshold of 0.3μg nickel/cm2is suggested to be used as the best estimate of a threshold for sensitisation by the Danish legislation. (Danish Environmental Protection Agency is the Rapporteur for the EU risk assessment reports of metallic nickel, nickel sulphate, nickel chloride, nickel nitrate and nickel carbonate prepared in relation to EEC Council Regulation 793/93, see final version of the Background Document, dated March 2008).
As sensitisation is assumed to require higher doses than elicitation this estimate for sensitisation is more conservative than the estimate for elicitation.
DNEL (skin sensitisation) = 0.3 µg Ni/cm² = 4.29 µg PBN1/cm² .Reported to a surface of hand of 960 cm2and a body weight of 70 kg., the DNEL expressed in µg/bg bw is 58.8.
The SCOEL has derived an 8 hour TWA for nickel and nickel compounds (SCOEL/SUM/85, May 2009 for public consultation) of 0.01 mg/m3. This value is based on protection from inflammatory effects in the lung but according to available evidence should also protect against carcinogenic effects.
As Ni is contained up to 7% in PBN1 mixture, carcinogenicity DNEL for inhalation of the substance is 0.14 mg/m3.
The 3-generation oral study in rats (Ambrose, 1976, Klimisch 2), where the dose of 22.5 mg/kg/day (expressed as Ni) was a serious LOAEL resulting in decreased pup survival, was selected for DNEL derivation, using a route-to-route extrapolation. The relevant systemic effect considered is the pup lethality. This effect was considered to bear a threshold mode of action.
- Modification of the starting point:
An oral-to-inhalation route extrapolation was applied, considering 100% absorption by inhalation and 50% absorption by oral route as recommended by the ECHA R.8 Guidance.
Corrected NOAEL (inhalation) for workers = 22.5 x (1/0.38) x 1/2 x 6.7/10 = 19.8 mg/m3/day
- Assessment factors:
The following assessment factors were applied:
• Interspecies differences (mainly toxicokinetic): 1 (route-to-route extrapolation)
• Remaining interspecies differences (mainly toxicodynamic): 2.5 (default value)
• Intraspecies differences: 5 (default value for workers)
• Differences in duration of exposure: 1 (chronic animal data)
• Issues related to severity and dose-response: 10 (because of the use of a LOAEL as a starting point and the severity of the toxic effects)
• Quality of whole database: 3 (study with limited investigations and reporting of data)
Global assessment factor (workers) = 1 x 2.5 x 5 x 1 x 10 x 3 = 375
- DNEL calculation:
DNEL (workers, inhalation, long-term, developmental effects) = 19.8 / 375 = 53 µg Ni/m3/day = 0.75 mg PBN1/m3/day
This value being higher than the long-term inhalation DNEL for systemic effects, the latter is considered for risk assessment.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
There are only industrial uses for the mixture. The rejects of the substance in the environment (water, air) is not expected. General population is not exposed to the substance by inhalation, dermal exposure or oral exposure.Therefore no DNEL is calculated for general population.
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