Cyclohexanaminium, N,N,N-trimethyl-, hydroxide (1:1)

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2.11 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):

62.5

Dose descriptor starting point:

NOAEL

Value:

150 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

132.23 mg/m³

Explanation for the modification of the dose descriptor starting point:

Relevant dose-descriptor: NOAEL = 150 mgkg bw/day as determined in subacute gavage study in rats

Modification of starting point:

- 50% / 100 %: ratio of oral to inhalation absorption (default according to ECHA Guidance R.8)

- 0.38 m³/kg bw: respiratory volume of a rat, corrected for 8 h exposure

- 6.7 m³/10 m³: correction for activity driven differences of respiratory volumes in workers compared to workers in rest

NOAEC corrected 150 * (50/100) * (1/0.38) * (6.7/10) = 132.23 mg/m³

AF for dose response relationship:

1

Justification:

NOAEL is used as starting point

AF for differences in duration of exposure:

5

Justification:

subacute study as staring point (Exposure duration was at least 31 days in males and 51 days in females, not resulting in differences in effects. Therefore, an assessment factor for exposure duration of 6 is considered overly conservative. Instead, an assessment factor of 5 was used, given that 90-day exposure would result in an assessment factor of 3.)

AF for interspecies differences (allometric scaling):

1

Justification:

not required (according to ECHA Guidance document R.8)

AF for other interspecies differences:

2.5

Justification:

accounting for interspecies differences (according to ECHA Guidance document R.8)

AF for intraspecies differences:

5

Justification:

accounting for differences in worker population

AF for the quality of the whole database:

1

Justification:

Guideline and GLP study

AF for remaining uncertainties:

1

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Acute/short term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

medium hazard (no threshold derived)

Additional information - workers

The test substance is corrosive to the skin (classified with H314), but did not show target organ toxicity at the highest dose that could be tested. Therefore, corrosive properties of the substance are considered prominent and qualitative risk management measures in accordance with ECHA Practical Guide E are implemented to control the risk for workers.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

No hazard or risk assessment was conducted for the general population since the test substance is exclusively used in industrial applications, no exposure of the general population is expected.