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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The test item did not show any adverse systemic effects either during short-term or long-term exposure. The test item was tested positive in the murine local lymph node assay without providing a threshold level of a non-sensitising concentration. In the combined repeat-dose/developmental screening study, squamous hyperplasia in the non-glandular stomach due to a local reaction resulting from a test material overload was noted in high dose levels. However, as humans do not possess a non-glandular stomach, this finding is not relevant for humans and consequently for the risk assessment. Based on the findings in the non-glandular stomach, the NOAEL (No Observed Adverse Effect Level) in rats for local effects was considered to be 250 mg/kg body weight/day.

Based on the fact that the histopathological findings observed in the non- glandular region of the stomach are a local reaction due to the test material overload, the NOAEL for systemic effects was considered to be 1000 mg/kg body weight/day for male and female rats.

Based on the occurrence of the histopathological findings observed in the non- glandular region of the stomach, which are a local reaction of the test item, the NOAEL for reproductive and developmental toxicity was considered to be 1000 mg/kg bodyweight/day for males and females.

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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

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

Based on the findings in the non-glandular stomach, the NOAEL (No Observed Adverse Effect Level) in rats for local effects was considered to be 250 mg/kg body weight/day. However, as humans do not possess a non-glandular stomach, this finding is not relevant for humans and consequently for the risk assessment.

Based on the fact that the histopathological findings observed in the non- glandular region of the stomach are a local reaction due to the test material overload, the NOAEL for systemic effects was considered to be 1000 mg/kg body weight/day for male and female rats.

Based on the occurrence of the histopathological findings observed in the non- glandular region of the stomach, which are a local reaction of the test item, the NOAEL for reproductive and developmental toxicity was considered to be 1000 mg/kg bodyweight/day for males and females.