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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
265.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
54
Dose descriptor starting point:
NOAEC
Value:
5 284 mg/m³
AF for differences in duration of exposure:
2
Justification:
Adjustment for subchronic to chronic
AF for intraspecies differences:
5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 998.52 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
9
Dose descriptor starting point:
LOAEC
Value:
14 090 mg/m³
AF for intraspecies differences:
3
AF for the quality of the whole database:
3

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:
25.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEC
Value:
5 284 mg/m³
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
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

 

Workers

The oral route was not considered As the acute dermal toxicity of MiPK was > 20 Ml/kg (16.1 g/kg), the acute dermal route was not calculated. 

               Acute Inhalation

An acute inhalation toxicity study gave a LOAEC of 4000 ppm (14090 mg/m3) which was based on reversible narcosis. The LOAEC was converted from the 6 hour exposure time in the study to a 15 minute STEL (short-term exposure limit) using Haber’s law. The corrected value was further adjusted for light work (from 6.7 M3to 10 m3per 8 hours = 0.67). Assessment factors of 3 for LOAEC to NOAEC and 3 for intraspecies were applied using ECETOC values.

- Converting ppm to mg/m3= (FW*ppm)/24.45 = (86.13*4000)/24.45 = 14090 mg/m3

- Converting to a 15 minute STEL with Habers law = cube root of ((14090 mg/m3 *6 hr)/0.25hr)3 = 40642 mg/m3

- Converting for light work = 40642 mg/m3* (0.67) = 26986 mg/m3

- Application of adjustment factors – 26986 mg/m3/9 =2998.52 mg/m3

               Long-term inhalation

A 90-day repeat dose inhalation study gave a NOAEC of 1500 ppm (5284 mg/m3) which was based on reversible narcosis. The NOAEC was converted from the 6 hour daily exposure to an 8 hour per day exposure (0.75) and was then adjusted for respiration for light work (0.67). ECHA assessment factors were applied, which consisted of subchronic to chronic studies (2), for intraspecies (5) for a total of 10.     

- Converting ppm to mg/m3= (FW*ppm)/24.45 = (86.13*750)/24.45 = 5284 mg/m3

- Converting for 6 hour exposure to 8 hour day and light work= 5284 mg/m3* (0.75) *(0.67) = 2655 mg/m3

- Application of adjustment factors – 2655 mg/m3/10 =265 mg/m3

Long term dermal

The dermal DNEL was found by correcting the inhalation DNEL for route and allometric scaling and light work was removed.

- Correct for inhalation to dermal = inhalation DNEL * sRV (0.38 m3/kg/ 8 hr) = 265 * 0.38 = 100.7 mg/kg bw/day

- Application of additional adjustment factor of 4 for rat/human allometric scaling = 100.7/4 = 25.1 mg/kg BW/ day

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
46.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 709.51 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
LOAEC

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:
13.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
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

 

General population

               Acute inhalation

The acute inhalation starts with the adjusted LOAEC of 14090 mg/m3as shown in the worker section. This is adjusted from a 6hr/day exposure to a 15 minute STEL (0.25), and no correction for light work. ECETOC adjustment factors of 3 for LOAEC to NOAEC and 5 for intraspecies are used, for a total of 15.

- Converting from a 6hr exposure to a 15 minute exposure with Haber’s law gives 40644 mg/m3 mg/m3

- Applciation of adjustment factors – 40644 mg/m3/15 =2709.66 mg/m3

               Long-term inhalation

The long-term inhalation starts with the adjusted LOAEC of 1981.5, which is the LOAEC corrected for a 6hr exposure to an 24 hour day, with no correction for light work. Adjustment factors are then applied, which consist of 2 for subchronic to chronic and 10 for intraspecies for a total of 20.

- Converting from a 6 hr exposure to a 24 hour expsoure = 52842*0.25 = 1321 mg/m3

- Adjusting from 5 days/wk to 7 days/wk = 1321*0.71 = 937.91

- Application of adjustment factors: 937.91 mg/m3/20 = 46.9 mg/m3

Long term dermal

The dermal DNEL was found by correcting the inhalation DNEL for route and allometric scaling.

- Correct for inhalation to dermal = inhalation DNEL * sRV (1.15 m3/kg/ 8 hr) = 46.9 * 1.15 = 53.9 mg/kg bw/day

- Application of additional adjustment factor of 4 for rat/human allometric scaling = 53.9/4 =13.4 mg/kg BW/ day