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EC number: 692-061-0 | CAS number: 1207435-39-9
- 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
Endpoint summary
Administrative data
Description of key information
The potential of Fast Pyrolysis Bio-oil to induce skin corrosion was analyzed by using the GLP compliant guideline study “In Vitro Membrane Barrier Test (CORROSITEX™ Assay)”, comprising a Chemical Detection System covered by a bio-barrier membrane. In the study, the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1C according to the UN GHS, as the mean time to activate the CDS was >30-60 min (48.75 ± 6.60 min.) (category 2). The test substance is therefore assigned to Packing Group 3 and to EU Risk-Phrase (R 34). Under the regulation 1272/2008/EC [CLP] the corresponding hazard statement is H314 "Causes severe skin burns and eye damage".
The potential of Fast Pyrolysis Bio-oil (the test item BIOTOX-21) to induce skin irritation / corrosion was evaluated in rabbits according to OECD (No. 404) and EC (2004/73/EC B.4) guidelines and in compliance with GLP. The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. As the test item showed corrosive properties on first animal, the study was considered complete and the test item was not evaluated on other animals. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated. The test item BIOTOX-21 is corrosive when applied topically to rabbits and according to the classification criteria laid down in 67/548/EEC, the test item BIOTOX-21 should be classified as corrosive and assigned the symbol C, the indication of danger "Corrosive" and the risk phrase R34 "Causes burns". Under the Regulation EC No 1272/2008 (CLP) the corresponding hazard statement is H314.
According to the two key studies, fast pyrolysis bio-oil is classified as corrosive, subcategory 1C with hazard statement H314 "Causes severe skin burns and eye damage".
Due to classification as corrosive, no study for eye irritation was needed.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 March 2005 - 11 March 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (final report not dated nor signed by the study director)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the study plan
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 2004/73/EC B.4, 29th April 2004
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Agence Francaise de Securite Sanitaire des Produits de Sante
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Controls:
- no
- Duration of treatment / exposure:
- The durations of exposure were 3 minutes, 1 hour and 4 hours.
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
- Number of animals:
- 1
- Irritation parameter:
- edema score
- Remarks:
- 4-hour exposure, mean of scores
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Irritation parameter:
- edema score
- Remarks:
- 4-hour exposure
- Basis:
- animal #1
- Time point:
- other: 48/72 h
- Score:
- 1
- Remarks on result:
- other: a very slight edema
- Irritation parameter:
- edema score
- Remarks:
- 4-hour exposure
- Basis:
- animal #1
- Time point:
- other: 1/24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- 4-hour exposure
- Basis:
- animal #1
- Time point:
- other: 1/24/48 h
- Score:
- 2
- Remarks on result:
- other: a well-defined erythema
- Irritation parameter:
- erythema score
- Remarks:
- 4-hour exposure
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Remarks on result:
- other: a marked ertythema
- Irritation parameter:
- erythema score
- Remarks:
- 4-hour exposure, mean of scores
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Irritant / corrosive response data:
- The test item Biotox-1 is corrosive under these experimental conditions when applied topically to rabbit skin.
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item BIOTOX-21 is corrosive when applied topically to rabbits. According to the classification criteria laid down in 67/548/EEC the test item should be classified as corrosive and assigned the symbol C, the indication of danger "Corrosive" and the risk phrase R34 "Causes burns". Under the Regulation EC No 1272/2008 (CLP) the corresponding hazard statement is H314 "Causes severe skin burns and eye damage".
- Executive summary:
The potential of the test item BIOTOX-21 to induce skin irritation was evaluated in rabbits according to OECD (No. 404) and EC (2004/73/EC B.4) guidelines and in compliance with GLP. The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. As the test item showed corrosive properties on first animal, the study was considered complete and the test item was not evaluated on other animals. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated. The interpretation of results was carried out according to the classification criteria laid down in 67/548/EEC.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-05-13 to 2013-05-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany
- Amount / concentration applied:
- TEST SYSTEM
- Bio-barrier membrane
TEST MATERIAL
- Amount applied: 500 µL - Observation period:
- 4 hours
- Details on study design:
- This assay is composed of three different steps:
1. Qualification
This step ensures that the sample is compatible with the CORROSITEX™ system. 150 µL or 150 mg of the test substance is added to the Qualify test tube. Solids are shaken to dissolve, if necessary. For immiscible liquids and insoluble solids the vial is shaken and let stand for one minute. If the colour or consistency of the CDS changes at the sample/testing fluid interface, the test material is qualified for the assay. If no reaction is observed within five minutes, the sample is not qualified for the CORROSITEX™ Assay.
2. Categorisation
This step establishes the category for cut-off times for the sample. 150 µL or 150 mg of the test substance is added to the tubes labeled Tube A and Tube B. After shaking a colour change in either of the tubes is matched to the corresponding colour charts on the CORROSITEX™ Testing Protocol Poster. Test materials having high acid/alkaline reserves are defined as Category 1 materials, while those with low acid/alkaline reserves are defined as Category 2 materials. If no colour change is observed in either tube, CONFIRM reagent is added to Tube B. After shaking, the resulting colour is matched to the colour chart on the CORROSITEX™ Testing Protocol Poster.
If the test item has strong colouring or shows other characteristics impairing a clear categorization according to the colour chart, the pH value can be measured in the tubes A and B and is used to confirm/determine the category of the test item
3. Classification
This step determines the appropriate Packing Group for the test sample. The CDS vials are warmed to room temperature (17 - 25˚C) before using. Vials 1 - 4 are utilized for sample replicate testing. Controls are set-up in parallel to the test item in order to confirm the validity of the test: positive control, negative control and one colour control. The Bio-barrier membranes are added on top of the vials. 500 µL oder 500 mg of the test item are applied evenly on the top of the BIOBARRIER disc and break-through time is recorded. - Irritation / corrosion parameter:
- penetration time (in minutes)
- Value:
- ca. 49
- Interpretation of results:
- corrosive
- Remarks:
- UN GHS Subcategory 1C, Packing Group: 3, EU Risk-Phrase: R 34) Criteria used for interpretation of results: other: OECD 435
- Conclusions:
- In this study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1C according to the UN GHS, as the mean time to activate the CDS was >30-60 min (category 2). The test substance is therefore assigned to Packing Group 3 and to EU Risk-Phrase (R 34). Under the regulation 1272/2008/EC [CLP] the corresponding hazard statement is H314.
- Executive summary:
The potential of the test substance to induce skin corrosion was analysed by using the “In Vitro Membrane Barrier Test (CORROSITEX™ Assay)”, comprising a Chemical Detection System covered by a bio-barrier membrane.
The test substance Fast Pyrolysis Bio-oil proved its ability to activate the CDS and was subsequently subjected to the timescale category test. The test substance was applied undiluted atop the bio-barrier membrane and the time required to activate the CDS was measured in four replicates. The mean time was compared to the given thresholds.
As the sample was intensely coloured and an indistinct color change was observed in the categorization assay, an additional pH measurement was performed to confirm the category of the test item. According to this pH-measurement the test item has been classified into category 2.
In this study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1C according to the UN GHS, as the mean time to activate the CDS was >30-60 min (48.75 ± 6.60 min.) (category 2). The test substance is therefore assigned to Packing Group 3 and to EU Risk-Phrase (R 34). Under the regulation 1272/2008/EC [CLP] the corresponding hazard statement is H314.
The controls confirmed the validity of the study. The positive control activated the CDS within three minutes (1.40 min.), the negative control did not activate the CDS before 60 min. (83.00 min.).
This study satisfies the requirement for Test Guideline OECD 435 for in vitro Membrane Barrier Test Method for Skin Corrosion.
Referenceopen allclose all
3 -minute exposure - Cutaneous examinations and mean values of the scores recorded for the animal (24, 48 and 72 hours)
Rabbit number |
Dermal Irritation |
Scores |
Mean irritation score (1) |
|||
1h |
24h |
48h |
72h |
|||
D1 |
D2 |
D3 |
D4 |
|||
19 |
Erythema |
0 |
1 |
1 |
0 |
0.7 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
C |
C |
C |
0 |
|
(1) mean of scores on days 2, 3 and 4
h = hour
D = day
C = beige coloration of the skin
1-hour exposure - Cutaneous examinations and mean values of the scores recorded for the animal (24, 48 and 72 hours)
Rabbit number |
Dermal Irritation |
Scores |
Mean irritation score (1) |
|||
1h |
24h |
48h |
72h |
|||
D1 |
D2 |
D3 |
D4 |
|||
19 |
Erythema |
2 |
2 |
2 |
4 |
2.7 |
Oedema |
0 |
2 |
2 |
2 |
2.0 |
|
Other |
C |
C |
C |
ZB |
|
(1) mean of scores on days 2, 3 and 4
h = hour
D = day
C = beige coloration of the skin
ZB = brownish area similar to a severe burn of the skin
4-hour exposure - Cutaneous examinations and mean values of the scores recorded for the animal (24, 48 and 72 hours)
Rabbit number |
Dermal Irritation |
Scores |
Mean irritation score (1) |
Interpretation (+) (-) |
|||
1h |
24h |
48h |
72h |
||||
D1 |
D2 |
D3 |
D4 |
||||
19 |
Erythema |
2 |
2 |
2 |
3 |
2.3 |
(+) |
Oedema |
0 |
0 |
1 |
1 |
0.7 |
(-) |
|
Other |
C |
C |
C |
C/S |
|
|
(1) mean of scores on days 2, 3 and 4
h = hour
D = day
(+) = irritant according to E.E.C. criteria
(-) = non-irritant according to E.E.C. criteria
S = dryness of the skin
C = beige coloration of the skin
Qualification Test / Categorization Test
The test substance was compatible with the CORROSITEX™ Assay, as assessed in the qualification step.As the sample was intensely coloured and an indistinct color change was observed in the categorization tubes A and B, an additional pH measurement was performed to confirm the category of the test item. Since the pH of the 10% solution of the test item was < 7 (3.1) and the pH in tube A was > 5 (6.6), the test item was classified into category 2.
Classification Test
CORROSITEX™ time [min] | Colour change | Consistency change | |
Replicate 1 | 56.00 | yes | no |
Replicate 2 | 49.00 | yes | no |
Replicate 3 | 40.00 | yes | no |
Replicate 4 | 50.00 | yes | no |
Mean +/- SD | 48.75 +/- 6.60 | ||
Positive Control | 1.40 | yes | no |
Negative Control | 83.00 | yes | no |
The mean time, required to activate the CDS was 48.75 +/- 6.60 min.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of skin irritation / corrosion endpoint:
GLP Guideline study
Justification for selection of eye irritation endpoint:
No testing needed because the substance is classified as a skin
corrosive
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: highly corrosive
Justification for classification or non-classification
In the in vitro skin corrosivity study under the given conditions the test substance showed corrosive effects. The test substance is classified as “CORROSIVE”, subcategory 1C according to the UN GHS, as the mean time to activate the CDS was >30-60 min (category 2). The test substance is therefore assigned to Packing Group 3 and to EU Risk-Phrase (R 34). Under the Regulation EC No 1272/2008 (CLP) the corresponding hazard statement is H314 "Causes severe skin burns and eye damage".
In addition, the test item BIOTOX-21 was found corrosive when applied topically to rabbits in a skin irritation / corrosion study. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. According to to the classification criteria laid down in 67/548/EEC, the test item BIOTOX-21 should be classified as corrosive and assigned the symbol C, the indication of danger "Corrosive" and the risk phrase R34 "Causes burns". Under the Regulation EC No 1272/2008 (CLP) the corresponding hazard statement is H314
According to Guidance on the application of Regulation EC No 1272/1008 (CLP) (ECHA 2009) in general, a classification for corrosivity in considered to implicitly cover the potential to cause respiratory tract irritation and so the additional category 3 classification is considered to be superfluous.
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