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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
Skin irritation / corrosion
Administrative data
- 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Fast Pyrolysis Bio-oil (BIOTOX-21)
- IUPAC Name:
- Fast Pyrolysis Bio-oil (BIOTOX-21)
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- Supplier: ASTON
name: BIOTOX-21
batch number: on the analytical certificate: 110205
description: brown liquid
storage conditions: at + 4 °C and protected from light
purity: 100 %
stability: February 2006.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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