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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:
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
DNEL value:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL 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
DNEL value:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL 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 NOAELoral; rep. dosefrom 90 day rat oral repeated dose toxicity study into an corrected NOAELderm; 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:

-absorptionoral-rat= absorptionderm-human (see Ad 2 of chapter R 8.4.2 of TGD)

 

corrected NOAELderm; rep.dose           = rat NOAELoral; rep. dose* (ABSoral-rat/ ABSderm-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 DNELderm; rep.dose  :

DNELderm; rep.dose  = corrected NOAELderm; rep.dose  / overall AF

DNELderm; rep.dose  = 25 mg/kg bw day / 100

DNELderm; rep.dose  = 0.25 mg/kg bw day

 

 



A2.)Conversion of an NOAELoral; rep. dosefrom 90 day oral rat repeated dose toxicity study into an corrected NOAECinhalation; 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

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

corrected NOAECinhalation; rep. dose= rat NOAELoral; rep. dose* (1 / sRVrat) *(ABSoral-rat/ ABSinh-human) * (sRVhuman/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: 

DNELinhalation; rep.dose = corrected NOAECinhalation; rep.dose  / overall AF

DNELinhalation; rep.dose = 22.0 mg/m3/ 25

DNELinhalation; 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 NOAELoral; developfrom developmental toxicity study into an corrected NOAECinhalation; 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

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

corrected NOAECinhalation; develop= rat NOAELoral; develop* (1 / sRVrat) *(ABSoral-rat/ ABSinh-human) * (sRVhuman/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 DNELdevelopcalculation 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 DNELdevelop. Thus extrapolation of duration of exposure is not needed and assessment factor is set on 1.

Calculation of DNELinhalation; develop :

DNELinhalation; develop = corrected NOAECinhalation; develop / overall AF

DNELinhalation; develop = 881.6 mg/m/ 25

DNELinhalation; develop = 35.3 mg/m




B2.)Conversion of an rat NOAELoral; developfrom developmental toxicity study into an corrected NOAELderm; develop (derived from example B.5; Appendix R 8-2 of TGD):

 

For workers (pregnant-able women only):

Assumptions:

-absorptionoral-rat= absorptionderm-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 exposurerat = frequency of exposureworker)

corrected NOAELderm; develop= rat NOAELoral; develop* (ABSoral-rat/ ABSderm-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 DNELdevelopcalculation 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 DNELdevelop. Thus extrapolation of duration of exposure is not needed and assessment factor is set on 1.


Calculation of DNEL
dermal; develop : DNELdermal; develop = corrected NOAECdermal; develop / overall AF DNELdermal; develop = 1000 mg/kg bw d / 100 DNELdermal; develop = 10 mg/kg bw d



 

B3.) Derivation of corrected NOAECinhalation; 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 NOAELoral; fertility; male/female from 90 day oral dog repeated dose toxicity study (INBIFO, 1974) into an corrected NOAECinhalation; 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)

- (ABSoral-dog/ ABSinh-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)

 

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

corrected NOAECinhalation; fertility; male/female

dog NOAELoral; fertility; male/female* (1 / sRVdog) * (ABSoral-dog/ ABSinh-human) * (sRVhuman/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 DNELinhalation; fertility : 

DNELinhalation; fertility = corrected NOAECinhalation; fertility; male/female / overall AF

DNELinhalation; fertility = 539.1 mg/m/ 50

DNELinhalation; fertility = 10.8 mg/m

 

 

B3.B)Conversion of an derived rat NOAELoral; fertility; male/female from a 3-generation study for the related substance epsilon-caprolactam in rats (MAK-Begründung, DFG, 1990) into an corrected NOAECinhalatory; fertility; male/femalefor 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)

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

 

corrected NOAECinhalatory; fertility; male/female=  rat NOAELoral; fertility; male/female* (1 / sRVrat) * (ABSoral-rat/ ABSinh-human) * (sRVhuman/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 DNELinhalation; fertility :

DNELinhalation; fertility = corrected NOAECinhalation; fertility; male/female / overall AF

DNELinhalation; fertility = 617.1 mg/m/ 25

DNELinhalation; fertility = 24.7 mg/m

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 theDNELinhalation; fertilityfor that purpose.

 

B4.) Derivation of corrected NOAECinhalatory; 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 (DNELdermal; fertility).

B4.A)Conversion of an derived dog NOAELoral; fertility; male/femalefrom 90 day oral dog repeated dose toxicity study (INBIFO, 1974) into an corrected NOAELderm; 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:

-absorptionoral-dog= absorptionderm-human (see Ad 2 of chapter R 8.4.2 of TGD)

 

corrected NOAELderm; fertility; male/female = dog NOAELoral; fertility; male/female* (ABSoral-dog/ ABSderm-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 DNELdermal; develop :

DNELdermal; fertility = corrected NOAECderm; fertility; male/female  / overall AF

DNELdermal; fertility = 350 mg/kg bw d / 70

DNELdermal; fertility = 5 mg/kg bw d

B4.B) Conversion of an derived rat NOAELoral; fertility; male/femalefrom a 3-generation study for the related substance epsilon-caprolactam in rats (MAK-Begründung, DFG, 1990) into an corrected NOAELderm; fertility; male/femalefor 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:

-absorptionoral-rat= absorptionderm-human (see Ad 2 of chapter R 8.4.2 of TGD)

 

corrected NOAELderm; fertility; male/female  =

rat NOAELoral; fertility; male/female* (ABSoral-rat/ ABSderm-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 DNELdermal; develop :

DNELdermal; fertility = corrected NOAECderm; fertility; male/female  / overall AF

DNELdermal; fertility = 500 mg/kg bw d / 100

DNELdermal; fertility = 5 mg/kg bw d

Conclusion:

Regarding calculationsB4.A) and B4.B) the calculations came to the same result (DNELdermal; 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.