Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
230 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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:
no hazard identified

Additional information - workers

In order to take into account the composition, especially the n-hexane content, of these UVCB substances, the reciprocal calculation procedure (RCP) was used to derive the DNEL. This procedure follows the American Conference of Governmental Industrial Hygienists' (ACGIH) advice for "complex mixtures" like UVCB substances and is recommended by the U. K. Health and Safety Executive for occupational exposure limit (OEL) calculations by hydrocarbon solvent manufacturers. The RCP is justified, as the toxicological properties of the components are additive and the differences between the vapour and liquid compositions do not substantially affect the calculated exposure limits (McKee et al., 2005).

In a first step, a maxiumum n-hexane content of 30% was identified by the registrant. As starting points for the derivation of DNELs by the RCP the lowest available long-term inhalation DNEL derived for workers for the other UVCB substances with < 5% n-hexane within this category, e. g. 2035 mg/m3, and the indicative OEL for n-hexane, e. g. 75 mg/m3, were used.

Assessment factors were chosen on the basis of ECETOC (2003) and other, more recent information. For route to route extrapolation, absorption differences were not taken into account.

McKee, R. H. et al. (2005). A proposed methodology for setting occupational exposure limits for hydrocarbon solvents. J Occup Environ Hyg, 2 (10), 524 -542.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
49 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
DNEL (Derived No Effect Level)
Value:
16 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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:
DNEL (Derived No Effect Level)
Value:
8 mg/kg bw/day
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

In order to take into account the composition, especially the n-hexane content, of these UVCB substances, the reciprocal calculation procedure (RCP) was used to derive the DNEL. This procedure follows the American Conference of Governmental Industrial Hygienists' (ACGIH) advice for "complex mixtures" like UVCB substances and is recommended by the U. K. Health and Safety Executive for occupational exposure limit (OEL) calculations by hydrocarbon solvent manufacturers. The RCP is justified, as the toxicological properties of the components are additive and the differences between the vapour and liquid compositions do not substantially affect the calculated exposure limits (McKee et al., 2005).

In a first step, a maxiumum n-hexane content of 30% was identified by the registrant. As starting points for the derivation of DNELs by the RCP the lowest available long-term inhalation DNEL derived for the general population for the other UVCB substances with < 5% n-hexane within this category, e. g. 447 mg/m3, and the indicative OEL for n-hexane, e. g. 75 mg/m3, were used.

Assessment factors were chosen on the basis of ECETOC (2003) and other, more recent information. For route to route extrapolation, absorption differences were not taken into account.