Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The following DN(M)EL could not be derived:

DN(M)ELs for acute / short term exposure, systemic effect

Dermal DN(M)EL for acute / short term exposure, local effect

Dermal DN(M)EL for long-term exposure, systemic effect

Dermal DN(M)EL for long-term exposure, local effect

The toxic effect of mixed cresol which is critical for the establishing a threshold value is the local highly irritating or even caustic property of mixed cresols to skin and mucous membranes.

However, there are no valid data in animals available for repeated dose toxicity using the inhalation route or the dermal route of exposure. Therefore dose-response information with respect to irritating or corrosive effects is not available.

In addition, as the test results from the available acute toxicity studies using inhalational or dermal exposure route are not graded due to the observed irritating effects, they also do not provide a basis for setting a DNEL. Thus, a threshold cannot be given and DNELs cannot be derived.

However, regularly performed occupational medical surveillance in a plant indid not report of complaints from irritating effects from workers (Currenta 2008) with measured maximal occupational cresol concentrations in the air of 0.9 mg/m³ which is regarded to be the NOAEC. With respect to the available MAK-values of strong organic acids (0.1 -25 mg/m³), this NOAEC is in the lower range of the MAK values for the strong organic acids and therefore the NOAEC of 0.9 mg/m³ can be used as surrogate for DNEL for local effects as a conservative approach.

With respect to dermal systemic toxicity the inhalation DNEL long term can be taken into account.

Remark:

It needs to be taken into consideration that mixed cresols are already classified as corrosive and labelled with R 34 = causes burns (R67/548/EEC, 19. ATP).Those substances are allocated to the moderate hazard band with defined risk management measures and operational conditions on the bases that exposure to such strong irritant substances should be well controlled.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

There are no consumer uses and no consumer exposure to mixed cresol. Therefore DNELs for the general public have not to be derived.