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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
2.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
24
Dose descriptor:
NOAEC
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

Long-term exposure Inhalation DNEL (local effects): starting point for the DNEL calculation is the NOEC of 50 mg/m3 from the 90-day repeated dose study conducted using dimethyl glutarate. The justification for using this as the starting point is given in the summary of the repeated dose toxicity section (7.5).

Assessment factors

Allometric Scaling - Not applicable to local effects

Remaining Differences - 2 - Effect of concern is local tissue damage due to irritation caused by the pH of the material after it hydrolyses locally in the upper respiratory tract. This effect is unlikely to be influenced by 'other differences' between rats and humans. However a factor of 2 is used to take into consideration the use of read across.

Worker - 3 - According to ECETOC report and a more recent report by the BfR a factor of 3 is considered to be adequate, particularly in the case of a local effect.

Time extrapolation - 2 - Due to the starting point coming from a 90 day study and the lack of information about how duration of exposure affects the NOEC a factor of 2 is justified to extrapolate from sub-chronic to chronic

Read Across - since the key study is on an analogue an additional factor of 2 is considered appropriate to take into account any minor differences in potency.

Total factor is therefore 24

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:
DNEL (Derived No Effect Level)
Value:
1.25 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Dose descriptor:
NOAEC
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

Long-term exposure Inhalation DNEL (local effects): starting point for the DNEL calculation is the NOEC of 50 mg/m3 from the 90-day repeated dose study conducted using dimethyl glutarate. The justification for using this as the starting point is given in the summary of the repeated dose toxicity section (7.5).

Assessment factors

Allometric Scaling - Not applicable to local effects

Remaining Differences - 2 - Effect of concern is local tissue damage due to irritation caused by the pH of the material after it hydrolyses locally inthe upper respiratory tract. This effect is unlikely to be influenced by 'other differences' between rats and humans. However a factor of 2 is included to account for the read across from the methyl esters.

Consumer - 5 - According to ECETOC report and a more recent report by the BfR a factor of 5 is considered to be adequate, particularly in the case of a local effect.

Time extrapolation - 2 - Due to the starting point coming from a 90 day study and the lack of information about how duration of exposure affects the NOEC a factor of 2 is justified to extrapolate from sub-chronic to chronic

Read Across - since the key study is on an analogue an additional factor of 2 is considered appropriate to take into account any minor differences in potency.

Total factor is therefore 40