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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance with modifications
Overall assessment factor (AF):
12
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176.3 mg/m³
Explanation for the modification of the dose descriptor starting point:

As no route-specific repeated inhalation toxicity data is available for the registration substance, per default a route-to-route extrapolation is performed for DNEL derivation using the lowest NOAEL of 100 mg/kg body weight per day based on a subchronic (90 -day) repeated oral toxicity study in rats. The corrected inhalatory NOAEC is obtained according to REACH Guidance R.8 as 176.3 mg/m3.

AF for dose response relationship:
1
Justification:
ECHA Guidance (reliable dose-response, POD is NOAEL)
AF for differences in duration of exposure:
2
Justification:
ECHA Guidance (subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA Guidance (inhalation route)
AF for other interspecies differences:
3
Justification:
No differences in ADME and/or toxicity expected as demonstrated experimentally in several species (rat, rabbit, dog). Combined AF for intraspecies and remaining uncertainty (toxicokinetic plus toxicodynamic aspect) based on German Committee on Hazardous Substances (AGS; BekGS901 dated April 2010) and ECETOC.
AF for intraspecies differences:
1
Justification:
No differences in ADME and/or toxicity expected within and between species as demonstrated experimentally.
AF for the quality of the whole database:
1
Justification:
Available data package very comprehensive and plausible
AF for remaining uncertainties:
2
Justification:
ECHA Guidance, route-to-route extrapolation (oral to inhalation)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH Guidance with modifications
Overall assessment factor (AF):
12
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification / adjustment of starting point based on low dermal absorption rate performed. Used starting pont is thus reflecting conservative assumptions.

AF for dose response relationship:
1
Justification:
ECHA Guidance (reliable dose-response, POD is NOAEL)
AF for differences in duration of exposure:
1
Justification:
ECHA Guidance (chronic toxicity studies available)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance (several species tested)
AF for intraspecies differences:
3
Justification:
No differences in ADME and/or toxicity expected as demonstrated experimentally in several species (rat, rabbit, dog). Combined AF for intraspecies and remaining uncertainty (toxicokinetic plus toxicodynamic aspect) based on German Committee on Hazardous Substances (AGS; BekGS901 dated April 2010) and ECETOC.
AF for the quality of the whole database:
1
Justification:
Available data package comprehensive and plausible
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

For the conclusion about the appropriateness of the assessment factors used for the derivation of DNELs regarding workers, the following aspects were considered and adjustments were made to characterize for uncertainty and variability when considered appropriate:

- overall confidence in the data base:

The data taken into account have been evaluated with regard to their reliability, relevance and completeness. Based hereupon no indications exist to assume limited reliabilty and/or a special extent of uncertainty of the data base.

- intra- and interspecies variation:

Corrections - when appropriate - have been made for potential intra- and interspecies differences between laboratory animals and humans using allometric scaling taking the toxicokinetic and/or toxicodynamic characteristics of the registration substance into account (4 for rats).

- nature and severity of effects:

The observed adverse effects in animals are primarily driven by the irritative nature of the technical grade registration substance and characterized as portal of entry effects. No further kinetic considerations apply.

- dose-response relationship:

There is no reason to assume special concern. Dose-response relationship with regard to special target organ toxicity which has to be taken into account was not observed. The dose descriptor starting points are considered to be mainly concentration dependent.

- differences in exposure (route, duration, frequency, and pattern):

No route-to-route extrapolation for the dermal scenario is considered as the dose descriptors used refer to this exposure route. Despite the very low dermal absorption rate of the registration substance (< 1%), no corrections are included in the DNEL derivation. For the inhalation route of exposure an assessment factor of 2 is judged to be sufficient. The starting point for inhalation assessment includes a correction for the respiratory volume of workers under light activity. Assessment factors for inter- and intra-species variation have been included when appropriate. Concerning both exposure routes (dermal and inhalation) an assessment factor of 3 was applied taken into account that data from various species are available. To account for duration extrapolation with regard to the dermal or inhalation route assessment factors of 1 and 2 have been used respectively taken into account that data from various species and exposure routes are available.

- other factors:

There are no other factors known that might require a particular margin of safety.

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

With regard to consumer exposure, the registered substance is used only in cosmetic products. Therefore, derivation of DNELs, assessment of exposure and risk characterization are not required under REACH. These uses are under the scope of Regulation (EC) 1223/2009 on cosmetic products.