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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
330 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
6
Dose descriptor starting point:
NOAEC
Value:
3 950 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 985 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting value of 3950 mg/m3 was modified to account for duration adjustment and differences in breathing volume in rats and humans with light worker activity.

Modified dose = 3950 mg/m3 x (6h/8h) x (6.7 m3 / 10 m3).

AF for dose response relationship:
1
Justification:
Point of departure is based on a NOAEC
AF for differences in duration of exposure:
2
Justification:
Factor of 2 is appropriate when extrapolating from a subchronic to a chronic duration of exposure [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not appropriate when extrapolating inhalation to inhalation exposure [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for intraspecies differences:
3
Justification:
Worker population [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
570 mg/m³
Most sensitive endpoint:
neurotoxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor starting point:
NOAEC
Value:
570 mg/m³
Explanation for the modification of the dose descriptor starting point:

Since the study was conducted with human volunteers exposed for 4 hours, no modification of the dose descriptor was considered to be necessary.

AF for dose response relationship:
1
Justification:
NOAEC Point of departure is based on a NOAEC
AF for intraspecies differences:
1
Justification:
12 healthy male volunteers were utilized in the study. The healthy subjects are representative of a healthy worker population. The critical endpoint for acute exposures to hydrocarbon solvents is transient nervous system depression. This endpoint is not expected to vary significantly within the healthy worker population.

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:
21 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
495 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
495 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Although human skin is considered to be less permeable than rat skin, a species-specific absorption factor was not used in the rat to human dermal DNEL calculations. Also 100% absorption through dermal application was assumed.

AF for dose response relationship:
1
Justification:
Point of departure is based on a NOAEL
AF for differences in duration of exposure:
2
Justification:
AF of 2 is appropriate when extrapolating from subchronic to chronic duration [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling (rat to humans) is appropriate when extrapolating from dermal exposures [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for intraspecies differences:
3
Justification:
Worker population [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
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

The potential exposure to the test material indicates that long-term exposure DNELs need to be derived for workers and for the general population. No acute toxicity was noted in any of the toxicological studies conducted. As noted in existing human volunteer studies, DNELs derived for chronic exposures are typically lower than those calculated for acute exposures and would therefore be protective of human for both the acute and chronic exposures.  Dermal and inhalation are the relevant routes of exposure. Aspiration is a potential hazard, but a DNEL calculation is not appropriate for an aspiration hazard.In instances where stable aerosol formation is expected, a value of 10 mg/m3 will be used as an operational control limit for inhalation exposure.Workers are expected to have infrequent and short-term exposures; however, for calculation of the DNEL for REACH purposes it is assumed that workers have maximal repeated exposure for 8 hr/day for 5 day/wk. 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
71 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
3 950 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
705 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor starting value of 3950 mg/m3 was modified to account for duration adjustment.

Modified dose = 3950 mg/m3 x (6h/24h) x (5 days/7 days).

AF for dose response relationship:
1
Justification:
Point of departure is based on a NOAEC
AF for differences in duration of exposure:
2
Justification:
AF of 2 is appropriate when extrapolating from subchronic to chronic duration [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not appropriate when extrapolating dermal to dermal exposure [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for intraspecies differences:
5
Justification:
General Population [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
570 mg/m³
Most sensitive endpoint:
neurotoxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor starting point:
NOAEC
Value:
570 mg/m³
Explanation for the modification of the dose descriptor starting point:

Since the study was conducted with human volunteers exposed for 4 hours, no modification of the dose descriptor was considered to be necessary.

AF for dose response relationship:
1
Justification:
Point of departure is based on a NOAEC
AF for intraspecies differences:
1
Justification:
12 healthy male volunteers were utilized in the study. The critical endpoint for acute exposures to hydrocarbon solvents is transient nervous system depression. This endpoint is not expected to vary significantly within the general population.

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:
12 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
495 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
495 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Although human skin is considered to be less permeable than rat skin, a species-specific absorption factor was not used in the rat to human dermal DNEL calculations. Also 100% absorption through dermal application was assumed.

AF for dose response relationship:
1
Justification:
Point of departure is based on a NOAEC
AF for differences in duration of exposure:
2
Justification:
AF of 2 is appropriate when extrapolating from subchronic to chronic duration [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling (rat to humans) is appropriate when extrapolating from oral exposures [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for intraspecies differences:
5
Justification:
General population [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
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:
21 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEC
Value:
3 950
Modified dose descriptor starting point:
NOAEL
Value:
818.2 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No long term or subchronic oral toxicity data on C9 -C14 aliphatics (2-25% aromatics) was available. Hence, an oral DNEL for general population was obtained by route to route exptrapolation from the available inhalation toxicity data. The NOAEC for a 90 -day exposure to C9 -C14 aliphatics (2 -25% aromatics) in rats was 690 ppm (3950 mg/m3). This value was converted to an oral NOAEL using the ECHA guidance. First the rat inhalation NOAEC was converted to a rat daily oral dose/NOAEL, taking into account the rat 6 -hr breathing volume/kg bw (0.29 m3/kg bw) and the difference in duration of exposure:

Rat oral NOAEL = 3950 mg/m3 x 0.29 mg/m3 x (5 days/7 days) = 818.2 mg/kg

AF for dose response relationship:
1
Justification:
Point of departure is based on a NOAEC
AF for differences in duration of exposure:
2
Justification:
AF of 2 is appropriate when extrapolating from subchronic to chronic duration [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling (rat to humans) is appropriate when extrapolating from oral exposures [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
AF for intraspecies differences:
5
Justification:
General population [ECETOC. (2003). Derivation of Assessment Factors for Human Health Risk Assessment. Technical Report No. 86].
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

The potential exposure to the test material indicates that long-term exposure DNELs need to be derived for general population. No acute toxicity was noted in any of the toxicological studies conducted. Additionally, DNELs derived for chronic exposures are typically lower than those calculated for acute exposures and would therefore be protective of human for both the acute and chronic exposures. Dermal and inhalation are the relevant routes of exposure. An oral DNEL was calculated for use in an indirect exposure assessment; the oral route is not expected to be a significant exposure route. Aspiration is a potential hazard, but a DNEL calculation is not appropriate for an aspiration hazard. Consumers in the general population are expected to have infrequent and short-term exposures. However, for calculation of DNELs for REACH, it is assumed that consumers have a maximal repeated dose for 24 hr/day for 7 day/wk.