Registration Dossier

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 substance Fatty acids, C18-unsatd., dimers, ethoxylated show the following effects in short/long term studies:

Acute toxicity:

LD50 oral > 2000 mg/kg bw (no treatment related effects) (BASFSE, 2012, 10A0072/12X137),

LD50 dermal > 5000mg/kg bw (no treatment related effects) (BASFSE, 2012, 11A0072/12X138)

Irritation:

EpiDerm™ skin irritation test, OECD 439: non-irritant (BASFSE, 2012, 61V0072/12A112)

EpiOcularTM Eye Irritation Test: non-irritant (BASFSE, 2012, 62V0072/12A113)

Sensitisation:

in vivo/vitro skin sensitisation: overall assessment, negative

Gentotoxicity:

Ames, OECD 471: negative (BASF SE, 2012, 40M0072/12M049)

HPRT, OECD 476: negative (BASF SE, 2013, 50M0072/12X104)

Micronucleus test in vitro, OECD 487: negative (BASF SE, 2012, 1483301)

Repeated dose toxicity:

Subacute Toxicity Study 28days, OECD 422: no adverse effects up to highest tested dosage, NOAEL  1000mg/kg bw/day (BASF SE, 2013, 85R0072/12X119)

Effects on reproduction:

reproduction screening, OECD 422: no adverse effects, NOAEL parental toxicity, fertility and development >= 1000 mg/kg bw/day test (BASF SE, 2013, 85R0072/12X119).

 

Therefore no hazard could be observed in any test performed, hence a DNEL could not be derived as no threshold could be identified.

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 substance Fatty acids, C18-unsatd., dimers, ethoxylated show the following effects in short/long term studies:

Acute toxicity:

LD50 oral > 2000 mg/kg bw (no treatment related effects) (BASFSE, 2012, 10A0072/12X137),

LD50 dermal > 5000mg/kg bw (no treatment related effects) (BASFSE, 2012, 11A0072/12X138)

Irritation:

EpiDerm™ skin irritation test, OECD 439: non-irritant (BASFSE, 2012, 61V0072/12A112)

EpiOcularTM Eye Irritation Test: non-irritant (BASFSE, 2012, 62V0072/12A113)

Sensitisation:

in vivo/vitro skin sensitisation: overall assessment, negative

Gentotoxicity:

Ames, OECD 471: negative (BASF SE, 2012, 40M0072/12M049)

HPRT, OECD 476: negative (BASF SE, 2013, 50M0072/12X104)

Micronucleus test in vitro, OECD 487: negative (BASF SE, 2012, 1483301)

Repeated dose toxicity:

Subacute Toxicity Study 28days, OECD 422: no adverse effects up to highest tested dosage, NOAEL  1000mg/kg bw/day (BASF SE, 2013, 85R0072/12X119)

Effects on reproduction:

reproduction screening, OECD 422: no adverse effects, NOAEL parental toxicity, fertility and development >= 1000 mg/kg bw/day test (BASF SE, 2013, 85R0072/12X119).

 

Therefore no hazard could be observed in any test performed, hence a DNEL could not be derived as no threshold could be identified.