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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:
13.1 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
980 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation is not the preferred route for absorption. Original value is NOAEL for developmental toxicity (equal to NOAEL reproductive toxicity and to NOAEL repeated toxicity)= 800 mg/kg bw/day obtained by a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422. Allometric scaling from rat to human is 4. The result is multiplied by 70 kg considered as the average weight of a human being (bw) and divided by 10 m^3/person considered as the average volume that is breathed in a 8h exposure. Conclusion [(800 mg/kg bw/d / 4)*70 kg bw]/10 m^3/person= 1400 mg/m^3. This value should be multiply by 0.5 (considering the oral absorption 50 % in oral-to-inhalation extrapolation) and by 1.4 (considering the correction for differences between human and experimental exposure conditions, i.e. 7 days per week (experimental)/ 5 days per week (worker population)). NAEC is 980 mg/ m^3.

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
1
Justification:
Already considered in NOAEC calculation (Appendix R 8.2).
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
5
Justification:
Default value proposed in ECHA R.8 Guidance for worker (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties. According to ECHA Guidance R8 an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take into account the lower sensitivity of the screening study for reproduction/developmental toxicity OECD TG 422 compared to a complete reproductive toxicity studies (OECD TG 414 and 416). For the multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite "this additional uncertain was not applied because no effect for reproduction/developmental toxicity was observed during the test. Moreover, a precautionary assessment factor for duration exposure was already applied because the treatment in OECD TG 422 study was performed for at least 29 days for males and at least for 51 days for females and so the duration was higher than a sub-acute study.
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:
3.73 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
other: NOAEL ( 800 mg/ kg bw/day) modified considering the differences between human and experimental exposure conditions.
Value:
1 120 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Original value was NOAEL for developmental toxicity (equal to NOAEL reproductive toxicity and to NOAEL repeated toxicity)= 800 mg/kg bw/day obtained by a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 was multiplied by 1.4 (considering the correction for differences between human and experimental exposure conditions, i.e. 7 days per week (experimental)/ 5 days per week (worker population)). Starting point = 800 mg/ kg bw/day * 1.4 = 1120 mg/ kg bw/day.

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
4
Justification:
Default value proposed in ECHA R.8 guidance ( table R 8.3)
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
5
Justification:
Default value proposed in ECHA R.8 Guidance for worker (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties. According to ECHA Guidance R8 an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take into account the lower sensitivity of the screening study for reproduction/developmental toxicity OECD TG 422 compared to a complete reproductive toxicity studies (OECD TG 414 and 416). For the multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite "this additional uncertain was not applied because no effect for reproduction/developmental toxicity was observed during the test. Moreover, a precautionary assessment factor for duration exposure was already applied because the treatment in OECD TG 422 study was performed for at least 29 days for males and at least for 51 days for females and so the duration was higher than a sub-acute study.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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 multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite" is classified H317 (Skin sens. cat.1) according to the CLP Regulation (EC n.1272/2008).

The assessment is done based on NOAEL for developmental toxicity (equal to NOAEL reproductive toxicity and to NOAEL repeated toxicity)= 800 mg/kg bw/day obtained by a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 on this substance.

 

The values of DNEL calculated for workers are:

 

INHALATION ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL= 13.1 mg/m^3 (NAEC= 980 mg/m^3 and Overall AF= 75)

b) SHORT TERM: No hazard identified

LOCAL EFFECTS: no hazard identified for LONG and for SHORT TERM exposure.

 

DERMAL ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL = 3.73 mg/kg bw/day (Starting point: 800 mg/kg bw/day (NOAEL for target substance) *1.4 = 1120 mg/kg bw/day and Overall AF= 300)

b) SHORT TERM: High hazard identified due to classification H317 (skin sens. cat.1)

LOCAL EFFECTS: No hazard identified for LONG AND SHORT TERM exposure based on the substance is not skin irritant and there is no reason of concern for acute dermal toxicity.

 

HAZARD FOR EYES:LOCAL EFFECTS: No hazard identified based on no sign of toxicity was noted in eye irritation study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Value:
300 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation is not the preferred route for absorption. Original value is NOAEL for developmental toxicity (equal to NOAEL reproductive toxicity and to NOAEL repeated toxicity)= 800 mg/kg bw/day obtained by a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422. Allometric scaling from rat to human is 4. The result is multiplied by 60 kg considered as the average weight of a human being (bw) and divided by 20 m^3/person considered as the average volume that is breathed by general population . Conclusion [(800 mg/kg bw/d / 4)*60 kg bw]/20 m^3/person= 600 mg/m^3. This value should be multiply by 0.5 (considering the oral absorption 50% in oral-to-inhalation extrapolation). NAEC is 300 mg/ m^3.

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
1
Justification:
Already considered in NOAEC calculation (Appendix R 8.2).
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
10
Justification:
Default value proposed in ECHA R.8 Guidance for general population (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties. According to ECHA Guidance R8 an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take into account the lower sensitivity of the screening study for reproduction/developmental toxicity OECD TG 422 compared to a complete reproductive toxicity studies (OECD TG 414 and 416). For the multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite "this additional uncertain was not applied because no effect for reproduction/developmental toxicity was observed during the test. Moreover, a precautionary assessment factor for duration exposure was already applied because the treatment in OECD TG 422 study was performed for at least 29 days for males and at least for 51 days for females and so the duration was higher than a sub-acute study.
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:
1.33 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL for developmental toxicity (equal to NOAEL reproductive toxicity and to NOAEL repeated toxicity)= 800 mg/kg bw/day obtained by a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422.

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
4
Justification:
Default value proposed in ECHA R.8 guidance ( table R 8.3).
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
10
Justification:
Default value proposed in ECHA R.8 Guidance for general population (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties. According to ECHA Guidance R8 an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take into account the lower sensitivity of the screening study for reproduction/developmental toxicity OECD TG 422 compared to a complete reproductive toxicity studies (OECD TG 414 and 416). For the multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite "this additional uncertain was not applied because no effect for reproduction/developmental toxicity was observed during the test. Moreover, a precautionary assessment factor for duration exposure was already applied because the treatment in OECD TG 422 study was performed for at least 29 days for males and at least for 51 days for females and so the duration was higher than a sub-acute study.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
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:
1.33 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
800 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation. NOAEL for developmental toxicity (equal to NOAEL reproductive toxicity and to NOAEL repeated toxicity)= 800 mg/kg bw/day obtained by a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 performed on this substance.

AF for dose response relationship:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for differences in duration of exposure:
6
Justification:
Default value proposed in ECHA R.8 Guidance for sub-acute to chronic (table R 8.6).
AF for interspecies differences (allometric scaling):
4
Justification:
Default value proposed in ECHA R.8 guidance ( table R 8.3).
AF for other interspecies differences:
2.5
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6).
AF for intraspecies differences:
10
Justification:
Default value proposed in ECHA R.8 Guidance for general population (table R 8.6).
AF for the quality of the whole database:
1
Justification:
Default value proposed in ECHA R.8 Guidance (table R 8.6) for database of good quality and reliability.
AF for remaining uncertainties:
1
Justification:
No further uncertainties. According to ECHA Guidance R8 an additional assessment factor of 2 to 5, decided on a case-by-case basis, should generally be used to take into account the lower sensitivity of the screening study for reproduction/developmental toxicity OECD TG 422 compared to a complete reproductive toxicity studies (OECD TG 414 and 416). For the multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite "this additional uncertain was not applied because no effect for reproduction/developmental toxicity was observed during the test. Moreover, a precautionary assessment factor for duration exposure was already applied because the treatment in OECD TG 422 study was performed for at least 29 days for males and at least for 51 days for females and so the duration was higher than a sub-acute study.
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 multi-constituent substance " Reaction mass of dodecane-1-thiol and tridodecyl trithiophosphite" is classified H317 (Skin sens. cat.1) according to the CLP Regulation (EC n.1272/2008).

The assessment is done based on NOAEL for developmental toxicity (equal to NOAEL reproductive toxicity and to NOAEL repeated toxicity)= 800 mg/kg bw/day obtained by a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 on this substance.

 

The values of DNEL calculated for general population are:

 

INHALATION ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL= 2 mg/m^3 (NAEC= 300 mg/m^3 and Overall AF= 150)

b) SHORT TERM: No hazard identified

LOCAL EFFECTS: no hazard identified for LONG and for SHORT TERM exposure.

 

DERMAL ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL = 1.33 mg/kg bw/day (NOAEL developmental toxicity for target substance= 800 mg/kg bw/day and Overall AF= 600)

b) SHORT TERM: High hazard identified due to classification H317 (skin sens. cat.1)

LOCAL EFFECTS: No hazard identified for LONG AND SHORT TERM exposure based on the substance is not skin irritant and there is no reason of concern for acute dermal toxicity.

 

 ORAL ROUTE:

SYSTEMIC EFFECTS:

a) LONG TERM: DNEL = 1.33 mg/kg bw/day (NOAEL developmental toxicity for target substance= 800 mg/kg bw/day and Overall AF= 600)

b) SHORT TERM: : No hazard identified based on the substance is not classified for acute oral toxicity

 

HAZARD FOR EYES:LOCAL EFFECTS: No hazard identified based on no sign of toxicity was noted in eye irritation study.