Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.44 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
90
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.28 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

Long-term DNELs are based on the 28 -day subacute oral toxicity study, which was performed with brake fluid containing 38% B-TTEGME (Shell, 1993a), administered to rats at doses of 9.5, 57 and 380 mg B-TTEGME/kg bw/day, based upon doses of 25, 150 and 1000 mg brake fluid/kg bw/day. This study was applied according to OECD 407 guideline and in compliance with GLP, therefore it was considered to be adequate, reliable and relevant. Dosing did not result in treatment related clinical signs, effects on body weight, clinical chemistry, haematology, gross pathology, organ weights and urinalysis. The only finding related to treatment was a very slight hepatocellular centrilobular hypertrophy at histology in males and some females at 380 mg B-TTEGME/kg/day or 1000 mg brake fluid/kg bw/day. Liver weight increases at this high dose compared to controls were approximately 7% in males and 3% in females. Considering the mild nature of the findings, and in the absence of any other relevant treatment related effect, this was not considered to constitute an adverse effect. The NOAEL was therefore considered to be at least 380 mg B-TTEGME/kg bw/day or 1000 mg brake fluid/kg bw/day. The other borated and non-borated glycol ethers and components present in the brake fluids also might have contributed to the findings. The DNELS derived from this study are therefore considered as 'preliminary DNELs'.

DNELs will be updated if new data become available.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.17 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.17 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Long-term DNELs are based on the 28 -day subacute oral toxicity study, which was performed with brake fluid containing 38% B-TTEGME (Shell, 1993a), administered to rats at doses of 9.5, 57 and 380 mg B-TTEGME/kg bw/day, based upon doses of 25, 150 and 1000 mg brake fluid/kg bw/day. This study was applied according to OECD 407 guideline and in compliance with GLP, therefore it was considered to be adequate, reliable and relevant. Dosing did not result in treatment related clinical signs, effects on body weight, clinical chemistry, haematology, gross pathology, organ weights and urinalysis. The only finding related to treatment was a very slight hepatocellular centrilobular hypertrophy at histology in males and some females at 380 mg B-TTEGME/kg/day or 1000 mg brake fluid/kg bw/day. Liver weight increases at this high dose compared to controls were approximately 7% in males and 3% in females. Considering the mild nature of the findings, and in the absence of any other relevant treatment related effect, this was not considered to constitute an adverse effect. The NOAEL was therefore considered to be at least 380 mg B-TEGME/kg bw/day or 1000 mg brake fluid/kg bw/day. The other borated and non-borated glycol ethers and components present in the brake fluids also might have contributed to the findings. The DNELS derived from this study are therefore considered as 'preliminary DNELs'.

DNELs will be updated if new data become available.