Registration Dossier
Registration Dossier
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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- 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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.47 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
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
Workers - Hazard for the eyes
Additional information - workers
DNELs are derived from systemic NOAELs.
Systemic effect DNELs: Based on a comparison of the different available studies the most reliable and relevant NOAEL for the derivations of a DNEL can be obtained from the studies collected in Table 21.
Local effect DNELs: In general systemic effects are more detrimental to the test organisms than local dermal reaction. Slight dermal reactions may be also reversible and therefore not adverse. As it is not possible to define clear thresholds for critical local (dermal) effects risk assessment was performed with the major focus based on adverse systemic effects.
Local effects as consequence of oral acute exposition are not considered.
Sensitisation / Irritiation DNELs: Based on the test results the substance is not classified as sensitising and not classified as irritant. Therefore there is no valid figure to derive a DNEL for these effects.
Comments about available DNELs: The derived DNELs are obtained from systemic effects, representing the most critical effect. These DNELs have been used for risk assessment. No further DNELs have been derived due to uncertainties during derivation.
Only tests for repeated dose toxicity oral route are available. The DNELs for inhalation and dermal routes have been derived following the approach described in the Guidance R8.
Derivation of DNELs (workers)
Assessment factor where derived as follows following ECETOC Technical Report no. 110) guidance
(1) Long-term, systemic effect, dermal (calculations)
Starting point: oral repeated dose NOAEL, systemic effects = 250 mg/kg bw/day
Assessment Factors:
Route-to-route extrapolation oral to dermal = 1
Interspecies (rat to humans) = 4
Intraspecies (worker) = 3
Exposure duration sub-acute to chronic = 6
Dose response = 1( not considered 3 as ECETOC guide based on irritation and sensitisation results)
Total AF = 72
DNEL (long-term, systemic effect, dermal) = 250 / 72 = 3.47 mg/kg bw/day
(2) Long-term, systemic effect, inhalation (calculations)
Starting point: oral repeated dose NOAEL, systemic effects = 250 mg/kg bw/day
Corrected NOAEC (8h worker) =oral NOAEL rat 250 / AS rat 4 x bw human 70 / 8h Volume 10 = 437.5 mg / m3 / 24h
Assessment Factors:
Route-to-route extrapolation oral to inhalation = 1 (already considered)
Interspecies (rat to humans) = 1 (already considered)
Intraspecies (worker) = 3
Exposure duration sub-acute to chronic = 6
Dose response = 1 (not considered 3 as ECETOC guide based on low volatility of the substance)
Total AF = 18
DNEL (long-term, systemic effect, inhalation) = 437.5 / 18 = 24 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 360
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
DNELs are derived from systemic NOAELs.
Systemic effect DNELs: Based on a comparison of the different available studies the most reliable and relevant NOAEL for the derivations of a DNEL can be obtained from the studies collected in Table 21.
Local effect DNELs: In general systemic effects are more detrimental to the test organisms than local dermal reaction. Slight dermal reactions may be also reversible and therefore not adverse. As it is not possible to define clear thresholds for critical local (dermal) effects risk assessment was performed with the major focus based on adverse systemic effects. Local effects as consequence of oral acute exposition are not considered.
Sensitisation / Irritiation DNELs: Based on the test results the substance is not classified as sensitising and not classified as irritant. Therefore there is no valid figure to derive a DNEL for these effects.
Comments about available DNELs: The derived DNELs are obtained from systemic effects, representing the most critical effect. These DNELs have been used for risk assessment. No further DNELs have been derived due to uncertainties during derivation.
Only tests for repeated dose toxicity oral route are available. The DNELs for inhalation and dermal routes have been derived following the approach described in the Guidance R8.
Derivation of DNELs (population)
Assessment factor where chosen following ECETOC Technical Report no. 110) guidance
(1) Long-term, systemic effect, dermal (calculations)
Starting point: oral repeated dose NOAEL, systemic effects = 250 mg/kg bw/day
Assessment Factors:
Route-to-route extrapolation oral to dermal = 1
Interspecies (rat to humans) = 4
Intraspecies (general population) = 5
Exposure duration sub-acute to chronic = 6
Dose response = 1(not considered 3 as ECETOC guide based on negative irritation and sensitisation results)
Total AF = 120
DNEL (long-term, systemic effect, dermal) = 250 / 72 = 2.1 mg/kg bw/day
(2) Long-term, systemic effect, inhalation (calculations)
Starting point: oral repeated dose NOAEL, systemic effects = 250 mg/kg bw/day
Corrected NOAEC (24 general population) =oral NOAEL rat 250 / AS rat 4 x bw human 70 / 24h Volume 20 = 218.75 mg / m3 / 24h
Assessment Factors:
Route-to-route extrapolation oral to inhalation = 1 (already considered)
Interspecies (rat to humans) = 1 (already considered)
Intraspecies (general population) = 5
Exposure duration sub-acute to chronic = 6
Dose response = 1 (not considered 3 as ECETOC guide based on low volatility of the substance)
Total AF = 30
DNEL (long-term, systemic effect, inhalation) = 218.75 /30 = 7.3 mg/m3
(3) Long-term, systemic effect, oral (calculations)
Starting point: oral repeated dose NOAEL, systemic effects = 250 mg/kg bw/day
Assessment Factors:
Interspecies (rat to humans) = 4
Intraspecies (general population) = 5
Exposure duration sub-acute to chronic = 6
Dose response = 3 (it is considered the damage on pregnant rats)
Total AF = 360
DNEL (long-term, systemic effect, inhalation) = 250 / 360 = 0.7 mg/kg bw/day
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