Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.301 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):
25
Modified dose descriptor starting point:
other: NOEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.505 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Based on the results from available studies on N-(cyclohexylthio)phtalimide (U.S. EPA data), for

worker population, the most sensitive endpoint was general toxicity, with the endpoint-specific

worker-DNELlong-term equal to 0.5 mg/kg bw/day for dermal route of exposure and 0.301 mg/m3

for

inhalation exposure.

Since the probability of the peak inhalation exposures of workers was confirmed for N-

(cyclohexylthio)phtalimide, acute DNEL for inhalation exposure was obtained by multiplication of

DNEL long-term inhalation by factor of 5 (DNELacute = 1.505 mg/m3

).

Concerning carcinogenicity, it was not considered as the critical health endpoint (see comment in

the section on Data availability). Even in the case that non-genotoxic carcinogenicity would show to

be a relevant health endpoint for humans, this effect would be covered within DNELs long-term,

derived from Repeated dose toxicity studies.

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

N-(cyclohexylthio)phtalimide is used in tens of thousand tons in EU. Production inside of European

Union is estimated on 2000 tons a year.

N-(cyclohexylthio)phtalimide is used as a pre-vulcanization inhibitor for synthetic and natural

rubber - in the manufacture of large rubber articles such as tires, tubes, hoses, belts and other

mechanical rubber products. Industrial use as a process regulator for polymerisation processes in

production of resins, rubbers and polymers is a major identified use. During the process of

polymerisation N-(cyclohexylthio)phtalimide is transformed into new chemical identity or bind in

the polymerisation complex which result into no availability for the environmental or consumer

exposure (VUCHT, a.s., Ing. Karol Kosár CSc., 2012).

For this reason there is expected negligible potential for a general population exposure as well as

consumer exposure.