Registration Dossier
Registration Dossier
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EC number: 700-867-1 | 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:
- 0.98 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 73.79 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- As no long-term study via inhalation is available, route-to-route extrapolation has been performed.
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in the route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for further assessment factor
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.395 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 418.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- As no long-term study via dermal route of exposure is available, route-to-route extrapolation has been performed
- AF for dose response relationship:
- 1
- Justification:
- starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- no need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- no need for further assessment factor
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:
- low hazard (no threshold derived)
Additional information - workers
Acute/Short-term exposure (systemic and local effects):
- an acute dermal toxicity study has been performed in rats with T002102 (Damme, 2001). The LD50 is considered to be greater than 2000 mg/kg. No hazard was identified for systemic effects. Therefore, a DNEL for acute dermal toxicity is not quantifiable.
- no reliable acute data were available for the inhalation route of exposure.
- based on the available data and according to the criteria laid down in the CLP regulation (EC) 1272/2008, T002102 is considered as classified eye irritant category 2 (H319), what implies an indication of the low hazard category for eyes. The hazard categories are indicated in the Guidance on Information Requirements and Chemical Safety Assessment - Part E Risk Characterisation.
Systemic effects - Long term exposure
Inhalation
The NOAEL (oral route) observed in the repeated dose toxicity study of Braun et al (2002) was used to derive a DNEL long-term, systemic effects via the inhalation route. This study was performed according to OECD guideline 407 and EU method B.7 in compliance with GLP. The NOAEL level was considered to be 41.85 mg/kg/day. After route-to-route extrapolation from oral to inhalation, the dose descriptor starting point NOAEC is 73.79 mg/m3 = 41.85 mg/kg/day x 1/0.38 m3/kg bw/day x 6.7m3/10m3. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m3/kg for 8 hours exposure of workers). For workers the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhalaed volumes in 8 hours under respective conditions (6.7 m3 for base level, 10m3 for light activity). No correction factor is required as bioavailability via the inhalation route and via the oral route of exposure is assumed to be 50%. With an overall assessment factor of 75 (6 for difference in duration subacute to chronic x 2.5 for other interspecies differences x 5 for intraspecies differences x 1 for quality of the database x 1 for remaining uncertainties), the long term DNEL, inhalation for systemic effects of 73.79 mg/m3/75 = 0.98mg/m3 is derived.
Dermal
The NOAEL (oral route) observed in the repeated dose toxicity study of Braun et al (2002) was used to derive a DNEL long-term systemic effects via the dermal route. The NOAEL was considered to be 41.85 mg/kg/day. After route-to-route extrapolation (oral to dermal) the dose descriptor starting point is 418.5 mg/kg = 41.85 mg/kg/day x 50/5 as the bioavailability via oral exposure is considered 50% while bioavailability via dermal exposure is considered to be 5%. The long-term dermal systemic DNEL is derived with an overall assessment factor of 300: 4 (interspecies difference rat to human) x 2.5 (remaining interspecies differences rat to human) x 6 (difference in duration subacute to chronic) x 5 (intraspecies differences worker population) x 1 (quality of database) x 1 (remaining uncertainties). A long-term, systemic dermal DNEL of 418.5 mg/kg/300 = 1.395 mg/kg/day is derived.
Local effects - long term exposure:
No reliable repeated dose toxicity study was available for this substance via the dermal and inhalation route of exposure. Therefore, a DNEL long-term exposure, local effects cannot be derived for the dermal and inhalation route.
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:
- no hazard identified
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
No DNEL derived for general population as no consumer use is expected.
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