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EC number: 262-996-5 | CAS number: 61788-67-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral to dermal AF = 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
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:
- low hazard (no threshold derived)
Additional information - workers
- 14-day repeated dose toxicity in the rat by oral route (range finding study): NOAEL≥1000 mg/kg bw/d;
- Combined short-term repeated dose toxicity and screening for reproductive/developmental toxicity in the rat by oral route (54 - 56-d duration): NOAEL≥1000 mg/kg bw/d.
Derivation of Quantitative DNELs
Workers may be exposed through dermal contact with the substances and these could involve acute or repeated dose exposures. Based on the expected handling/use and chemical properties of the FLL Substances, inhalation and oral exposure are not considered likely.
DNEL for Long-Term, Dermal, Systemic Effects
The following two repeated dose toxicity studies in rats have been conducted for FLL Sample 3 and FLL Sample 4 with similar results obtained for each sample (refer to Table 2):
The second study meets the definition of subacute according to Chapter R.8 and also included examination of potential reproductive effects. In addition, it is supported by the shorter-term 14-d study where similar results were obtained. Thus, the NOAEL of 1000 mg/kg bw/d was used as the starting point for the estimation of the DNEL for long-term, dermal, system effects for the FLL Substances as a whole. This was the maximum dosage applied in each test; no effects on mortality, health of the test organisms, or reproductive parameters of the test organisms were observe at any of the doses tested.
The oral NOAEL was converted to the corrected dermal NOAEL as prescribed in ECHA Guidance Chapter R.8 according to Equation 1
Where:
Parameters |
Definition |
Value |
Reference/Rationale |
ABSoral-rat |
relative oral absorption in the rat |
1 |
For oral-to-dermal extrapolation, Chapter R.8 recommends default factors of 1 based on the assumption that, in general, dermal absorption will not be higher than oral absorption. |
ABSderm-human |
relative dermal absorption in humans |
1 |
As recommended by ECHA (under the assumption of equal absorption in rats and humans), this value was used directly as the “corrected” NOAEL for DNEL development and therefore the corrected dermal NOAEL was 1000 mg/kg bw/d.
To estimate the DNELlong-term,dermal, the following assessment factors (AFs) to account for (i) differences in duration of exposure and (ii) key uncertainties associated with the DNEL development were applied to the corrected dermal NOAEL:
AFs |
Value |
Rationale |
Interspecies |
4 (allometric scaling) 2.5 (remaining differences) |
For systemic effects, Chapter R.8 recommends a (rat-to-human) allometric scaling factor of 4. For systemic effects, Chapter R.8 recommends a factor of 2.5 to account for “remaining differences”. |
Intraspecies |
5 |
Chapter R.8 recommends a factor of 5 for workers given that this subpopulationdoes not cover very young, very old and very ill. |
Exposure duration |
6 |
The NOAEL study duration was 8 weeks (between subacute and subchronic according to Chapter R.8). Chapter R.8 recommends a subchronic to chronic AF of 2 and a subacute to chronic AF of 6. Erring on the side of caution, the AF of 6 was selected. |
Dose-response |
1 |
A NOAEL was used as the starting point for the DNEL and there were no unusual dose-response issues (as described in Chapter R.8) resulting in a default factor of 1. |
Quality of database |
2 |
There was correspondence in results for each of the 4 tests conducted on the Samples of FLL Substances and the NOAELs determined in the studies were limit values (i.e.,no effects at the highest test concentration) providing confidence in this NOAEL as a starting point for the DNEL. However, some adjustment is warranted given that a repeated dose dermal study has not been conducted for the FLL Substances. |
Overall AF |
600 |
Product of individual AFs. |
Note that while most of the AFs are based on the values prescribed in Chapter R.8, the AF for quality of database was based primarily on professional judgement. Chapter R.8 does not prescribe values for quality of database but recommends that quality of database be considered when deriving the DNELs. Selection of the value of 2 for quality of database was intended to reflect uncertainty in possible responses between dermal and oral exposures. The value of 2 is intermediate between the following two situations described by WHO/IPCS (1994):Minor deficiencies in the data exist with respect to quality, quantity or omission; andData base considered complete for the evaluation of the compound under consideration.
It was considered to provide an appropriate balance between the lack of a repeated dose dermal toxicity study for the FLL Substances, and the conservative assumption made with respect to dermal absorption of the samples.
Application of the AFs to the corrected dermal NOAEL resulted in aDNELlong-term,dermalof 1.67 mg/kg-bw/d for worker exposure.
DNEL for Acute, Dermal, Systemic Effects
The following acute (single dose) toxicity study in rats has been conducted for FLL Sample 3 and FLL Sample 4 with similar results obtained for each sample (refer to Table 2):
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Although the purpose of the study was to estimate the LD50 for the Samples, the lack of mortality, or clinical effects at any dose allows for inference of a NOAEL of 2000 mg/kg bw (the maximum dose tested). This value was used as the starting point for the estimation of the DNEL for acute, dermal, system effects for the FLL Substances as a whole. It was considered appropriate when compared with the subacute repeated dose oral NOAEL of 1000 mg/kg bw that has also been determined that applies for mortality, clinical effects and reproductive effects. In general, it is expected that single dose toxicity would occur at a higher concentration than subacute repeated-dose toxicity (assuming equal absorption between the two exposure routes) and the lack of a large difference between the two values suggests that the acute NOAEL is reasonably conservative.
To estimate the DNELacute,dermal, the following assessment factors (AFs) to account for key uncertainties associated with the DNEL development were applied to the corrected dermal NOAEL:
AFs |
Value |
Rationale |
Interspecies |
4 (allometric scaling) 2.5 (remaining differences) |
For systemic effects, Chapter R.8 recommends a (rat-to-human) allometric scaling factor of 4. For systemic effects, Chapter R.8 recommends a factor of 2.5 to account for “remaining differences”. |
Intraspecies |
5 |
Chapter R.8 recommends a factor of 5 for workers given that this subpopulationdoes not cover very young, very old and very ill. |
Dose-response |
1 |
A NOAEL was used as the starting point for the DNEL and there were no unusual dose-response issues (as described in Chapter R.8) resulting in a default factor of 1. |
Quality of database |
2 |
There was correspondence in results for the two tests conducted on FLL Samples 3 and 4 and the NOAELs determined in the studies were limit values (i.e.,no effects at the highest test concentration) providing confidence in this NOAEL as a starting point for the DNEL. However, some adjustment is warranted given that a only two studies, using similar dosing conditions and species, have been conducted. |
Overall AF |
100 |
Product of individual AFs. |
Note that an AF was not applied for duration of exposure because the acute exposure scenario was assumed to consider a single exposure, similar to the acute study.
The AF for quality of database was based primarily on professional judgement. Chapter R.8 does not prescribe values for quality of database but recommends that quality of database be considered when deriving the DNELs. Selection of the value of 2 for quality of database was intended to reflect potential uncertainty in responses among test species under varying dosing conditions. The value of 2 is intermediate between the following two situations described by WHO/IPCS (1994):Minor deficiencies in the data exist with respect to quality, quantity or omission; and data base considered complete for the evaluation of the compound under consideration.
Application of the AFs to the corrected dermal NOAEL resulted in aDNELacute,dermalof 20 mg/kg-bw for a single worker exposure.
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Repeated dose Toxicity - Oral
The repeated-dose, oral NOAEL of 1000 mg/kg bw/d was used as starting point for estimation of the DNEL for repeated dose oral toxicity for systemic effects under public exposures, for the FLL Substances as a whole. As recommended in ECHA TGD Chapter R.8. (under the assumption of equal absorption in rats and humans), this value was used directly as the “corrected” NOAEL for DNEL development.
To estimate the DNELoral-environment, the following AFs were applied to account for (i) differences between rats and humans and (ii) key uncertainties associated with the DNEL development:
AFs |
Value |
Rationale |
|||
Interspecies |
4 (allometric scaling) 2.5 (remaining differences) |
For systemic effects, Chapter R.8 recommends a (rat-to-human) allometric scaling factor of 4. For systemic effects, Chapter R.8 recommends a factor of 2.5 to account for “remaining differences”. |
|||
Intraspecies |
10 |
Chapter R.8 recommends a factor of 10 for the general public to account for subpopulations including thevery young, very old and very ill. |
|||
Exposure duration |
6 |
The NOAEL study duration was 8 weeks (between subacute and subchronic according to Chapter R.8). Chapter R.8 recommends a subchronic to chronic AF of 2 and a subacute to chronic AF of 6. Erring on the side of caution, the AF of 6 was selected. |
|||
Dose-response |
1 |
A NOAEL was used as the starting point for the DNEL and there were no unusual dose-response issues (as described in Chapter R.8) resulting in a default factor of 1. |
|||
Quality of database |
1 |
There was correspondence in results for each of the 4 tests conducted on the FLL Substances and the NOAELs determined in the studies were limit values (i.e.,no effects at the highest test concentration) providing confidence in this NOAEL as a starting point for the DNEL. |
|||
Overall AF |
600 |
Product of individual AFs. |
The AF for quality of database was based primarily on professional judgement. Given the consistent results obtained from four repeated dose studies of the FLL Samples 3 and 4, and the toxicity observed for other types of studies (i.e.,acute oral and dermal, as well as irritation/corrosivity, mutagenicity and reproductive toxicity screening), it is expected that the starting-point NOAEL would be conservative (i.e.,protective of possible effects via the oral pathway).
Application of the AFs to the corrected oral NOAEL resulted in aDNELoral-environmentof 1.67 mg/kg-day for human exposure via the environment.
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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