Registration Dossier
Registration Dossier
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EC number: 614-587-1 | CAS number: 68551-92-8
Toxicological Summary
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.
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