Dodecane-12-lactam

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.88 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):

25

Dose descriptor starting point:

NOAEL

Value:

25 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

22 mg/m³

Explanation for the modification of the dose descriptor starting point:

Converting the oral NOAEL rat into a inhalation NOAEL is necessary to derive the correct starting point for the inhalation route for which no reliable repeated study is available.

(see A2.) in Discussion in section 5.11.2 of CSR).

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).

AF for differences in duration of exposure:

2

Justification:

A assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic to chronic (see section R 8.4.3.1, Table R.8-5) (ECHA, Nov. 2012).

AF for interspecies differences (allometric scaling):

1

Justification:

According to wxample B3 of Appendix R 8-2 of TGD (ECHA, Nov. 2012).

AF for other interspecies differences:

2.5

Justification:

A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.

AF for intraspecies differences:

5

Justification:

For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov. 2012).

AF for the quality of the whole database:

1

Justification:

Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).

AF for remaining uncertainties:

1

Justification:

No further assessment factors are considered necessary.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.88 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

DNEL extrapolated from long term DNEL

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

repeated dose toxicity

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.25 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):

100

Dose descriptor starting point:

NOAEL

Value:

25 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

25 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Converting the oral NOAEL rat into a dermal NOAEL is necessary to derive the correct starting point for the dermal route for which no study was carried out.

(see A1. in Discussion in section 5.11.2 of CSR).

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).

AF for differences in duration of exposure:

2

Justification:

A assessment factor 2 is suggested by the ECHA TGD for exposure duration from subchronic to chronic (see section R 8.4.3.1, Table R.8-5) (ECHA, Nov. 2012).

AF for interspecies differences (allometric scaling):

4

Justification:

An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov. 2012) for interspecies differences.

AF for other interspecies differences:

2.5

Justification:

A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.

AF for intraspecies differences:

5

Justification:

For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov. 2012).

AF for the quality of the whole database:

1

Justification:

Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).

AF for remaining uncertainties:

1

Justification:

No further assessment factors are considered necessary.

Acute/short term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.25 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

DNEL extrapolated from long term DNEL

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

repeated dose toxicity

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - workers

Oral exposure for workers is not considered to be a relevant exposure pathway. Hence DNEL´s for oral exposure of workers are not derived.

Regarding to the outcome of the toxicological studies relevant local effects of dodecane-12 -lactam (lauryl lactam) are not known. Hence DNEL´s for local effects could not be derived.

The relevant DNELs are derived in the discussion part of section 5.11.2 of the Chemical Safety Report (CSR) and summarized in the table in section 5.11.2 of the CSR.

A) Derivation of corrected dose descriptors (correct starting point), selection of assessment factors and calculation of relevant/critical DNEL´s according to Technical Guidance Document “Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health” published by European Chemicals Agency in May 2008 (in the following described as “TGD”)

A1.) Conversionof an rat NOAEL_{oral; rep. dose}from 90 day rat oral repeated dose toxicity study into an corrected NOAEL_{derm; rep. dose} (derived from example B.5; Appendix R 8-2 of TGD “Chapter R.8: Characterisation of dose [concentration]-response for human health”):

 

For workers:

assumptions:

-absorption_oral-rat= absorption_derm-human (see Ad 2 of chapter R 8.4.2 of TGD)

 

corrected NOAEL_{derm; rep.dose}           = rat NOAEL_{oral; rep. dose}* (ABS_oral-rat/ ABS_derm-human) 

                                                                                                    

                                                             = 25 mg/kg bw day * 1

 

                                                              = 25 mg/kg bw day

 

 

 Selected assessment factors (according to Table R 8-6 of the TGD): 

Description	Factor
Interspecies: factor for allometric scaling (systemic)	4
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	5
Exposure duration (systemic; subchronic to chronic)	2
Dose-response (systemic)	1*
Quality of the database (systemic; overall)	1**
overall Assessment Factor (overall AF)	100

* Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
 **Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD

Calculation of DNEL_{derm; rep.dose}  :

DNEL_{derm; rep.dose}  = corrected NOAEL_{derm; rep.dose}  / overall AF

DNEL_{derm; rep.dose}  = 25 mg/kg bw day / 100

DNEL_{derm; rep.dose}  = 0.25 mg/kg bw day

 

 

A2.)Conversion of an NOAEL_{oral; rep. dose}from 90 day oral rat repeated dose toxicity study into an corrected NOAEC_{inhalation; rep. dose} (derived according to figure R 8-3 Chapter R 8.4.2 and example B 3 of Appendix R 8-2 of TGD)

For workers:

assumptions:

- 8h exposure/d

- (ABS_oral-rat/ ABS_inh-human) = 0.5(according to Ad 2 of Chapter 8.4.2 of TGD)

corrected NOAEC_{inhalation; rep. dose}= rat NOAEL_{oral; rep. dose}* (1 / sRV_rat) *(ABS_oral-rat/ ABS_inh-human) * (sRV_human/wRV)

= 25 mg/kg bw d * (1/ 0.38 m³/kg bw d) * 0.5 * (6.7 m³(8h) / 10 m³(8h))

= 22.0 mg/m³

Selected assessment factors (according to Table R 8-6 of the TGD): 

Description	Factor
Interspecies: factor for allometric scaling (systemic)	1*
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	5
Exposure duration (systemic; subchronic to chronic)	2
Dose-response (systemic)	1**
Quality of the database (systemic; overall)	1***
overall Assessment Factor (overall AF)	25

*  see example B 3 of Appendix R 8-2 of TGD

** Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
***Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD

Calculation of DNEL: 

DNEL_{inhalation; rep.dose} = corrected NOAEC_{inhalation; rep.dose}  / overall AF

DNEL_{inhalation; rep.dose} = 22.0 mg/m³/ 25

DNEL_{inhalation; rep.dose} = 0.88 mg/m³

 

 

B)Derivation of corrected dose descriptors (correct starting point), selection of assessment factors and calculation of DNEL´s according to TGD which are considered to be not critical/not relevant DNEL´s because this DNEL´s are covered by the critical/relevant DNEL´s described under A) (please note: these DNEL´s here are only presented for retracing and transparency reasons as required by ECHA)

B1.)Conversion of a rat NOAEL_{oral; develop}from developmental toxicity study into an corrected NOAEC_{inhalation; develop} (derived according to figure R 8-3 Chapter R 8.4.2 and example B 3 of Appendix R 8-2 of TGD)

For workers (for pregnant-able women only):

assumptions:

- 8h exposure/d

- (ABS_oral-rat/ ABS_inh-human) = 0.5(according to Ad 2 of Chapter 8.4.2 of TGD)

corrected NOAEC_{inhalation; develop}= rat NOAEL_{oral; develop}* (1 / sRV_rat) *(ABS_oral-rat/ ABS_inh-human) * (sRV_human/wRV

= 1000 mg/kg bw d * (1/ 0.38 m³/kg bw d) * 0.5 * (6.7 m³(8h) / 10 m³(8h))

= 881.6 mg/m³

Selected assessment factors (according to Table R 8-6 of the TGD): 

Description	Factor
Interspecies: factor for allometric scaling (systemic)	1*
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	10****
Exposure duration (systemic)	1*****
Dose-response (systemic)	1**
Quality of the database (systemic; overall)	1***
overall Assessment Factor (overall AF)	25

*  see example B 3 of Appendix R 8-2 of TGD
** Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
***Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD

****According to TGD Appendix R 8-12: Pregnant women have to be considered as a more vulnerable population. When deciding on assessment factors for the DNEL_developcalculation the developing offspring should be the focus of attention. Therefore intraspecies factor of 5 for workers is enhanced 2-fold resulting in an assessment factor of 10.
*****The exposure and the scope of the animal OECD 414 study is limited to the prenatal stadium and thus it has to be considered to be a chronic exposure for the unborn foetus, which is the focus of attention in this study and regarding the derivation of the DNEL_develop. Thus extrapolation of duration of exposure is not needed and assessment factor is set on 1.

Calculation of DNEL_{inhalation; develop} :

DNEL_{inhalation; develop} = corrected NOAEC_{inhalation; develop} / overall AF

DNEL_{inhalation; develop} = 881.6 mg/m³ / 25

DNEL_{inhalation; develop} = 35.3 mg/m³ 

B2.)Conversion of an rat NOAEL_{oral; develop}from developmental toxicity study into an corrected NOAEL_{derm; develop} (derived from example B.5; Appendix R 8-2 of TGD):

 

For workers (pregnant-able women only):

Assumptions:

-absorption_oral-rat= absorption_derm-human (see Ad 2 of chapter R 8.4.2 of TGD)

-for human: daily oral ingestion during gestation from implantation until delivery

(frequency of exposure_rat = frequency of exposure_worker)

corrected NOAEL_{derm; develop}= rat NOAEL_{oral; develop}* (ABS_oral-rat/ ABS_derm-human)

= 1000 mg/kg bw day * 1

= 1000 mg/kg bw day

Selected assessment factors (according to Table R 8-6 of the TGD): 

Description	Factor
Interspecies: factor for allometric scaling (systemic)	4
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	10****
Exposure duration (systemic)	1*****
Dose-response (systemic)	1**
Quality of the database (systemic; overall)	1***
overall Assessment Factor (overall AF)	100

 

** Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
***Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
**** According to TGD Appendix R 8-12: Pregnant women have to be considered as a more vulnerable population. When deciding on assessment factors for the DNEL_developcalculation the developing offspring should be the focus of attention. Therefore intraspecies factor of 5 for workers population is enhanced 2-fold resulting in an assessment factor of 10.

*****The exposure and the scope of the animal OECD 414 study is limited to the prenatal stadium and thus it has to be considered to be a chronic exposure for the unborn foetus, which is the focus of attention in this study and regarding the derivation of the DNEL_develop. Thus extrapolation of duration of exposure is not needed and assessment factor is set on 1.

Calculation of DNEL_{dermal; develop} : DNEL_{dermal; develop} = corrected NOAEC_{dermal; develop} / overall AF DNEL_{dermal; develop} = 1000 mg/kg bw d / 100 DNEL_{dermal; develop} = 10 mg/kg bw d

 

B3.) Derivation of corrected NOAEC_{inhalation; fertility; male/female} 

Conclusion: According to an worst case assumption the lower DNEL derived from calculations B3.A) and B3.B) will be considered as an endpoint specific DNEL. Hence calculationdescribed in B3.A) is relevant to derive the endpoint specific DNEL.

 

 

B3.A)Conversion of an derived dog NOAEL_{oral; fertility; male/female} from 90 day oral dog repeated dose toxicity study (INBIFO, 1974) into an corrected NOAEC_{inhalation; fertility; male/female} (derived according to figure R 8-3 Chapter R 8.4.2 and example B 3 of Appendix R 8-2 of TGD under consideration of differences in exposure conditions as described in figure R 8-2 in chapter R8.4.2 of TGD ):

For workers:
assumptions:

- 8h exposure/d; 5d/wk

- frequency of exposure of dog (6d/wk) ≠ frequency of exposure of worker (5d/wk)

- (ABS_oral-dog/ ABS_inh-human) = 0.5(according to Ad 2 of Chapter 8.4.2 of TGD)

- dog respiratory volume (ventilation rate) = 9000 l/d^#

- body weight (beagle dog): 11.5 kg^#

 (^#Source: International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, ICH harmonised tripartite guideline “Impurities: Guideline for residual solvents Q3C(R4)”, current step 4 version dated February 2009, page 17)

 

sRV_dog (8h exposure/d)= (9000 l * 8h/d) / (24h * 11.5 kg) = 260.9 l / kg bw d = 0.261 m³/kg bw d

corrected NOAEC_{inhalation; fertility; male/female}= 

dog NOAEL_{oral; fertility; male/female}* (1 / sRV_dog) * (ABS_oral-dog/ ABS_inh-human) * (sRV_human/wRV) * (exp. cond._dog/ exp. cond._human)

= 350 mg/kg bw d * (1/ 0.261 m³/kg bw d) * 0.5 * (6.7 m³(8h) / 10 m³(8h)) * (6d/wk / 5d/wk)

= 539.1 mg/m³

Selected assessment factors (according to Table R 8-6 of the TGD): 

Description	Factor
Interspecies: factor for allometric scaling (systemic)	1*
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	5
Exposure duration (systemic;subchronic to chronic)	2
Dose-response (systemic)	1**
Quality of the database (systemic; overall) additional assessment factor for fertility	1*** 2****
overall Assessment Factor (overall AF)	50

 

*  see example B 3 of Appendix R 8-2 of TGD
** Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
***Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
**** according to Appendix R 8-12 of the TGD an additional assessment factor was used to account for lower sensitivity of a repeated dose toxicity study regarding detection of effects on reproductive organs due to few animals in the exposure groups and a possible increased sensitivity in the developing foetuses and young animals

Calculation of DNEL_{inhalation; fertility} : 

DNEL_{inhalation; fertility} = corrected NOAEC_{inhalation; fertility; male/female} / overall AF

DNEL_{inhalation; fertility} = 539.1 mg/m³ / 50

DNEL_{inhalation; fertility} = 10.8 mg/m³ 

 

 

B3.B)Conversion of an derived rat NOAEL_{oral; fertility; male/female} from a 3-generation study for the related substance epsilon-caprolactam in rats (MAK-Begründung, DFG, 1990) into an corrected NOAEC_{inhalatory; fertility; male/female}for lauryl lactam(derived according to figure R 8-3 Chapter R 8.4.2 and example B 3 of Appendix R 8-2 of TGD under consideration of differences in exposure conditions as described in figure R 8-2 in chapter R8.4.2 of TGD ):

For workers:

assumptions:

- 8h exposure/d; 5d/wk

- frequency of exposure of rat (7d/wk) ≠ frequency of exposure of worker (5d/wk)

- (ABS_oral-rat/ ABS_inh-human) = 0.5(according to Ad 2 of Chapter 8.4.2 of TGD)

 

corrected NOAEC_{inhalatory; fertility; male/female}=  rat NOAEL_{oral; fertility; male/female}* (1 / sRV_rat) * (ABS_oral-rat/ ABS_inh-human) * (sRV_human/wRV) * (exp. cond._rat/ exp. cond._human)

= 500 mg/kg bw d * (1/ 0.38 m³/kg bw d) * 0.5 * (6.7 m³(8h) / 10 m³(8h)) * (7d/wk / 5d/wk)

= 617.1 mg/m³

 

Selected assessment factors (according to Table R 8-6 of the TGD): 

Description	Factor
Interspecies: factor for allometric scaling (systemic)	1*
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	5
Exposure duration (systemic; chronic)	1
Dose-response (systemic)	1**
Quality of the database (systemic; overall)	2***
overall Assessment Factor (overall AF)	25

*  see example B 3 of Appendix R 8-2 of TGD

** Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD

***Because alternative data from related substance epsilon-caprolactam is used which is associated with some additional uncertainty in the dose descriptor derived a higher assessment factor of 2 is used (see chapter R 8.4.3.1 of TGD)

Calculation of DNEL_{inhalation; fertility} :

DNEL_{inhalation; fertility} = corrected NOAEC_{inhalation; fertility; male/female} / overall AF

DNEL_{inhalation; fertility} = 617.1 mg/m³ / 25

DNEL_{inhalation; fertility} = 24.7 mg/m³ 

Conclusion:

Regarding calculations B3.A) and B3.B) the calculation described in B3.A) results in the most conservative DNEL, which is considered to be theDNEL_{inhalation; fertility}for that purpose.

 

B4.) Derivation of corrected NOAEC_{inhalatory; fertility; male/female} 

Conclusion: According to an worst case assumption the lower DNEL derived from calculations B4.A) and B4.B) will be considered as an endpoint specific DNEL. Result of calculations B4.A) and B4.B): the calculations came to the same result (DNEL_{dermal; fertility}).

B4.A)Conversion of an derived dog NOAEL_{oral; fertility; male/female}from 90 day oral dog repeated dose toxicity study (INBIFO, 1974) into an corrected NOAEL_{derm; fertility; male/female} (derived from example B.5; Appendix R 8-2 of TGD and under consideration of differences in exposure conditions as described in figure R 8-2 in chapter R8.4.2 of TGD ):

 

 

For workers:

assumptions:

-absorption_oral-dog= absorption_derm-human (see Ad 2 of chapter R 8.4.2 of TGD)

 

corrected NOAEL_{derm; fertility; male/female} = dog NOAEL_{oral; fertility; male/female}* (ABS_oral-dog/ ABS_derm-human)

= 350 mg/kg bw day * 1

= 350 mg/kg bw day

Selected assessment factors (according to Table R 8-6 of the TGD):

Description	Factor
Interspecies: factor for allometric scaling (systemic)	1.4
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	5
Exposure duration (systemic;subchronic to chronic)	2
Dose-response (systemic)	1**
Quality of the database (systemic; overall) additional assessment factor for fertility	1*** 2****
overall Assessment Factor (overall AF)	70

                      

** Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD
***Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD

**** according to Appendix R 8-12 of the TGD an additional assessment factor was used to account for lower sensitivity of a repeated dose toxicity study regarding detection of effects on reproductive organs due to few animals in the exposure groups and a possible increased sensitivity in the developing foetuses and young animals.

 

Calculation of DNEL_{dermal; develop} :

DNEL_{dermal; fertility} = corrected NOAEC_{derm; fertility; male/female}  / overall AF

DNEL_{dermal; fertility} = 350 mg/kg bw d / 70

DNEL_{dermal; fertility} = 5 mg/kg bw d

B4.B) Conversion of an derived rat NOAEL_{oral; fertility; male/female}from a 3-generation study for the related substance epsilon-caprolactam in rats (MAK-Begründung, DFG, 1990) into an corrected NOAEL_{derm; fertility; male/female}for lauryl lactam(derived from example B.5; Appendix R 8-2 of TGD and under consideration of differences in exposure conditions as described in figure R 8-2 in chapter R8.4.2 of TGD )

For workers:

assumptions:

-absorption_oral-rat= absorption_derm-human (see Ad 2 of chapter R 8.4.2 of TGD)

 

corrected NOAEL_{derm; fertility; male/female}  =

rat NOAEL_{oral; fertility; male/female}* (ABS_oral-rat/ ABS_derm-human)

= 500 mg/kg bw day * 1

= 500 mg/kg bw day

 

Selected assessment factors (according to Table R 8-6 of the TGD):

Description	Factor
Interspecies: factor for allometric scaling (systemic)	4
Interspecies: remaining differences (systemic)	2.5
Intraspecies (systemic)	5
Exposure duration (systemic; chronic)	1
Dose-response (systemic)	1**
Quality of the database (systemic; overall)	2***
overall Assessment Factor (overall AF)	100

** Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD

***Because alternative data from related substance epsilon-caprolactam is used which is associated with some additional uncertainty in the dose descriptor derived a higher assessment factor of 2 is used (see chapter R 8.4.3.1 of TGD)

 

Calculation of DNEL_{dermal; develop} :

DNEL_{dermal; fertility} = corrected NOAEC_{derm; fertility; male/female}  / overall AF

DNEL_{dermal; fertility} = 500 mg/kg bw d / 100

DNEL_{dermal; fertility} = 5 mg/kg bw d

Conclusion:

Regarding calculationsB4.A) and B4.B) the calculations came to the same result (DNEL_{dermal; fertility}  ) .

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

Cited from SIAR for SIAM 17 (Arona, Italy, November 11-14, 2003): “Dodecane-12-lactam is not used directly in consumer products.” Hence, DNEL´s are derived for workers only and not for general population.