Registration Dossier
Registration Dossier
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EC number: 239-888-1 | CAS number: 15790-07-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15985:1.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.469 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 88.158 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.833 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - workers
Toxico-kinetics
A weight of evidence has been adopted in predicting the bio-accumulation potential of the target chemicalaluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex. In-vivo studies in Rat and Rabbit with the read-across chemicaldisodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate have shown that the chemical is rapidly metabolized and excreted out of the living system through urine and fecal route.Therefore, it has been concluded that the target chemical is also unlikely to bio-accumulate in-vivo.
Acute toxicity
Acute toxicity of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex to rat by the oral route indicates that the substance does not exhibits acute toxicity by the oral route. Similarly the acute values of inhalation also indicates that the substance does not exhibits acute toxicity by the inhalative route. Thus, it can be inferred that the target substance is non toxic to oral and inhalation route of exposure.
Irritation / corrosion
In vivo studies of the substance show that the substance is not irritating to skin and eyes, and so the substance is not classified in any of the category as per the C&L regulation.
Sensitisation
According to the quantitative structure activity relationship model prediction, aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex was predicted as not being sensitizing to guinea pig skin by Guinea pig maximisation test.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.362 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 43.478 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL extrapolated from long term DNEL
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.417 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.208 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
DNEL derivation
Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is non acute toxic to oral, dermal and inhalation route, shows no irritation effect to skin and eye, is not genotoxic and is not developmental and reproductive toxic.
In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.
In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.
A standard approach to deriving DNEL values would be to use the develpomental toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 100 mg/kg bw/d in oral category.
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