Registration Dossier
Registration Dossier
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EC number: 272-347-8 | CAS number: 68814-95-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.12 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 750
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 87.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- route to rout extrapolation according to ECHA guideance oral -> inhalative worker
- AF for dose response relationship:
- 1
- Justification:
- according to ECHA guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic according to ECHA guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already considered in startingpoint correction
- AF for other interspecies differences:
- 2.5
- Justification:
- according to ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- human worker according to ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- according to ECHA guidance
- AF for remaining uncertainties:
- 10
- Justification:
- Dose response issues (LOAEL to NOAEL) according to ECHA guidance
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:
- high hazard (no threshold derived)
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)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Based on a comparison of the different available studies the most reliable and relevant NOAEL for the derivations of a DNEL can be obtained from the following studies:
Most sensitive record for systemic effects is:
- Subacute Toxicity Study 28days, oral, rat, OECD 422, up to 400mg/kg bw/day tested: Result LOAEL >= 50mg/kg bw/d (BASF SE, 2013, 85R0674/12X380).
As no lower concentration was tested the LOAEL reflects only a low dosage at which a effect can be observed. Nevertheless
further assessment factors are applied to address the possible lower NOAEL. For this a assessment factor 10 is chosen as the observed effects even in the lowest dose were present in some animals, but a clear dose response was observed (leading effect cardiomyophaty).
Most sensitive record for local effects:
- Skin irritation, Rabbit, 4h, OECD 404, RA from CAS 1116-76-3: severe reaction, skin irritant Cat. 2 (BASF SE, 1988, 18H0264/882108)
- Eye irritation, Rabbit, OECD 405, RA from CAS 1116-76-3: slight to mild signs, eye irritant Cat 2 (BASF SE, 1988, 11H0264/882109)
- Skin sensitisation, in vivo, guinea pig, Bühler, OECD 406: negative (BASF SE, 2013, 32H0674/12X410)
The test systems used to assess local effects are not able to deliver a quantitative dose-response information. Therefore a qualitative RA for local effects is performed.
The inhalation DNEL was derived using route-to-route extrapolation as there is no adequate subacute/subchronic studies for inhalation available.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
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 a comparison of the different available studies the most reliable and relevant NOAEL for the derivations of a DNEL can be obtained from the following studies:
Most sensitive record for systemic effects is:
- Subacute Toxicity Study 28days, oral, rat, OECD 422, up to 400mg/kg bw/day tested: Result LOAEL >= 50mg/kg bw/d (BASF SE, 2013, 85R0674/12X380).
As no lower concentration was tested the LOAEL reflects only a low dosage at which a effect can be observed. Nevertheless
further assessment factors are applied to address the possible lower NOAEL. For this a assessment factor of 10 is chosen as the observed effects even in the lowest dose were present in some animals. But a clear dose response was observed (leading effect cardiomyophaty) showing that the effect is decreasing.
Most sensitive record for local effects:
- Skin irritation, Rabbit, 4h, OECD 404, RA from CAS 1116-76-3: severe reaction, skin irritant (BASF SE, 1988, 18H0264/882108)
- Eye irritation, Rabbit, OECD 405, RA from CAS 1116-76-3: slight to mild signs, eye irritant cat 2
(BASF SE, 1988, 11H0264/882109)
- Skin sensitisation, in vivo, guinea pig, Bühler, OECD 406: negative (BASF SE, 2013, 32H0674/12X410)
The test systems used to assess local effects are not able to deliver a quantitative dose-response information. Therefore a qualitative RA for local effects is performed.
All DNELs were derived using, if necessary, route-to-route extrapolation if there is no adequate subacute/subchronic studies for dermal or inhalation available.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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