Registration Dossier

Administrative data

Workers - 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

Workers - 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance has no harmonized toxicological classification. No adverse effects have been observed in studies at the highest recommended dose tested:

- 1000 mg/kg bw/day, in a sub-acute toxicity study by oral route (OECD 407, GLP)

- 1000 mg/kg bw.day, in a sub-chronic toxicity study by oral route (OECD 408, GLP) conducted on the supporting substance, 1,4-cyclohexanedicarboxylic acid;

- Equivalent to 888 mg/kg bw/day (males) and to 1124 mg/kg bw/day (females) (achieved dose), in a reproduction/developmental screening study conducted on an analogue substance (OECD 421, GLP);

Moreover, tests assessing the mutagenic potential of the substance in vitro provided no evidence of mutagenic or genotoxic activity.

Indications of toxicity to reproduction and development were not observed in a reproduction/developmental toxicity screening test conducted on an analogue substance.

As no adverse effects have been observed for any of the relevant human heath endpoints, no DNEL can be derived. Hence, exposure assessment of workers is not needed.

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

The substance has no harmonized toxicological classification. No adverse effects have been observed in studies at the highest recommended dose tested:

- 1000 mg/kg bw/day, in a sub-acute toxicity study by oral route (OECD 407, GLP)

- 1000 mg/kg bw.day, in a sub-chronic toxicity study by oral route (OECD 408, GLP) conducted on the supporting substance,1,4-cyclohexanedicarboxylic acid;

- Equivalent to 888 mg/kg bw/day (males) and to 1124 mg/kg bw/day (females) (achieved dose), in a reproduction/developmental screening study conducted on an analogue substance (OECD 421, GLP);

Moreover, tests assessing the mutagenic potential of the substance in vitro provided no evidence of mutagenic or genotoxic activity.

Indications of toxicity to reproduction and development were not observed in a reproduction/developmental toxicity screening test conducted on an analogue substance.

As no adverse effects have been observed for any of the relevant human heath endpoint, no DNEL can be derived. Hence, exposure assessments of consumers and humans exposed via the environment are not needed.