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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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 test substance has been tested in one repeated dose toxicity study (28 days) according to OECD guideline 422 and revealed no test-item related signs of toxicity. The NOAEL for systematic toxicity is above the highest administered dose 1000 mg test item/kg b.w./day, p.o.. In addition, a repeated dose toxicity study (90 days) according to OECD TG 408 was conducted with DINCD and revealed no test-item related effects. Based on these results, the NOAEL was established as being at least 1000 mg/kg/day for males and females. No substance related local or systemic adverse effects could be observed up to the tested limit dose.


In the prenatal developmental toxicity study in rats according to OECD TG 414 no maternal toxicity was observed up to the highest dose level tested (1000 mg/kg/day). Moreover, no developmental toxicity was observed up to the highest dose level tested (1000 mg/kg/day). In conclusion, based on the results of this prenatal developmental toxicity study in rats the maternal and developmental No Observed Adverse Effect Levels for DINCD were reported to be at least 1000 mg/kg bw/d.


For dermal route of exposure, no adverse effects were reported in the in vitro skin irritation/corrosion study and in the in vivo skin sensitization study.


Conclusion:


No effects (local or systemic)  have been observed at limit dose in all available guideline toxicological studies. Thus, no hazard could be identified and no DNEL/DMEL is derived. This applies for oral, dermal and inhalation exposure since a comparable toxicity profile is to be expected for all three routes of exposure.    

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 test substance has been tested in one repeated dose toxicity study (28 days) according to OECD guideline 422 and revealed no test-item related signs of toxicity. The NOAEL for systematic toxicity is above the highest administered dose 1000 mg test item/kg b.w./day, p.o.. In addition, a repeated dose toxicity study (90 days) according to OECD TG 408 was conducted with DINCD and revealed no test-item related effects. Based on these results, the NOAEL was established as being at least 1000 mg/kg/day for males and females. No substance related local or systemic adverse effects could be observed up to the tested limit dose.


In the prenatal developmental toxicity study in rats according to OECD TG 414 no maternal toxicity was observed up to the highest dose level tested (1000 mg/kg/day). Moreover, no developmental toxicity was observed up to the highest dose level tested (1000 mg/kg/day). In conclusion, based on the results of this prenatal developmental toxicity study in rats the maternal and developmental No Observed Adverse Effect Levels for DINCD were reported to be at least 1000 mg/kg bw/d.


For dermal route of exposure, no adverse effects were reported in the in vitro skin irritation/corrosion study and in the in vivo skin sensitization study.


Conclusion:


No effects (local or systemic)  have been observed at limit dose in all available guideline toxicological studies. Thus, no hazard could be identified and no DNEL/DMEL is derived. This applies for oral, dermal and inhalation exposure since a comparable toxicity profile is to be expected for all three routes of exposure.