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EC number: 939-409-2 | CAS number: 1329-99-3
- 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
Key acute dermal irritation and eye irritation studies in rabbits were conducted with Depanol I, demonstrating slight reactions both for skin and eye irritation, however below threshold for classification.
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:
- 14.12.1984-19.12.1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, however few data were available on test substance composition. Nevertheless it is considered relevant, reliable and adequate for classification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Albino New Zealand, Hy / Cr
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Weight at study initiation: 2410 g mean weight
- Housing: Individually in polystyrene cages (0.35 x 0.55 x 0.32 m); each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): Ad libitum with a certified pelleted diet Rabbit Diet SQC (Special Diets Services Ltd, Witham, Essex England)
- Water (e.g. ad libitum): Tap water filtered with Millipore filters in water bottles ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 50% ± 30%
- Air changes (per hr): No data (The incoming, non-recycled air, was filtered by an absolute filter.)
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2 of the back and flanks
- % coverage: Not provided
- Type of wrap if used: The treated area was covered with a hydrophilic gauze patch (Codex) to prevent loss of test material. The test material and the gauze patch were held in contact with the skin with a semi-occlusive patch adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: See under "Any other information on material and methods incl. tables" - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1.84
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: animal found dead day 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hour
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.39
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: animal found dead day 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these experimental conditions and according to the directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
- Executive summary:
An acute dermal irritation study was performed with the compound Depanol I in six New-Zealand rabbits, according to the OECD Guideline No. 404 and the OECD Guideline for Good Laboratory Practice.
Erythema and oedema were observed in all animals one hour after instillation (very slight to moderate erythema and very slight to slight oedema). Oedema disappeared from Day 2 to Day 4 and erythema from Day 4 to Day 5.
Under these experimental conditions and according to the Directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
Reference
Evaluation of skin reactions
|
Rabbit |
D1 |
D2 |
D3 |
D4 |
D5 |
Erythema |
01 |
1 |
2 |
2 |
1 |
0 |
02 |
1 |
2 |
2 |
- |
- |
|
03 |
2 |
2 |
2 |
2 |
0 |
|
04 |
2 |
1 |
1 |
1 |
0 |
|
05 |
3 |
3 |
2 |
0 |
- |
|
06 |
2 |
3 |
3 |
2 |
0 |
|
Oedema |
01 |
1 |
1 |
0 |
0 |
0 |
02 |
1 |
1 |
0 |
- |
- |
|
03 |
1 |
1 |
0 |
0 |
0 |
|
04 |
1 |
0 |
0 |
0 |
0 |
|
05 |
2 |
1 |
1 |
0 |
- |
|
06 |
1 |
1 |
1 |
0 |
0 |
The animal no. 02 was found dead on Day 4
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, however few data were available on test substance composition. Nevertheless it is considered relevant, reliable and adequate for classification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Albino New Zealand, Hy / Cr
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France (76410 Saint Aubin les Elbeuf, France)
- Age at study initiation: Not provided
- Weight at study initiation: 2390 g mean weight
- Fasting period before study: Not provided
- Housing: Individually in polystyrene cages (0.35 x 0.55 x 0.32 m); each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): Ad libitum with a certified pelleted diet Rabbit Diet SQC (Special Diets Services Ltd, Witham, Essex England)
- Water (e.g. ad libitum): Tap water filtered with Millipore filters in water bottles ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 50% ± 30%
- Air changes (per hr): No data (The incoming, non recycled air, was filtered by an absolute filter.)
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- A dose of 0.1 mL of the test compound was instilled into the inferior conjunctival sac of the left eye of each rabbit with a plastic syringe. The upper and lower eye lids were held together for several seconds to avoid any loss of test substance. The right eye served as control.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.73
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 dyas
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.73
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 dyas
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hour
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these experimental conditions and according to the directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
- Executive summary:
An acute eye irritation study was performed with the compound Depanol I after instillation into the conjunctival sac of six New-Zealand rabbits, according to OECD Guideline 405 and the OECD Guideline for Good Laboratory Practice.
Chemosis, redness appeared in all animals on Day 1. These reactions disappeared between Day 4 and Day 5. No reactions were observed on the iris and cornea.
Under these experimental conditions and according to the Directive 83/467 EEC concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
Reference
Eye irritation evaluation
|
Scores |
D1 (1 hour) |
D2 (24 hours) |
||||||||||
|
Rabbit No. |
01 |
02 |
03 |
04 |
05 |
06 |
01 |
02 |
03 |
04 |
05 |
06 |
Con-junctivae |
Chemosis |
3 |
3 |
3 |
3 |
3 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Redness |
2 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
|
Iris |
Degree of congestion |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Scores |
D3 |
D4 |
D5 |
||||||||||
|
Rabbit No. |
01 |
02 |
03 |
04 |
05 |
06 |
01 |
02 |
03 |
04 |
05 |
06 |
01 |
Con-junctivae |
Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Redness |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
Degree of congestion |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea |
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A key acute dermal irritation study was performed with the compound Depanol I in six New-Zealand rabbits, according to the OECD Guideline No. 404 and the OECD Guideline for Good Laboratory Practice (Hoechst AG, 1985). Erythema and edema were observed in all animals one hour after instillation (very slight to moderate erythema and very slight to slight edema). Edema disappeared from Day 2 to Day 4 and erythema from Day 4 to Day 5. Under these experimental conditions and according to the Directive 83/467 EEC or CLP regulation No. 1272/2008 concerning classification, the packing and the labeling of the dangerous substances, the compound was considered as non-irritant.
A key acute eye irritation study (Hoechst AG, 1985)
was performed with the compound Depanol I after instillation into the
conjunctival sac of six New-Zealand rabbits, according to OECD
Guideline 405 and the OECD Guideline for Good Laboratory Practice.
Chemosis, redness appeared in all animals on Day 1. These reactions
disappeared between Day 4 and Day 5. No reactions were observed on the
iris and cornea.
Under these experimental conditions and according to the directive
83/467 EEC or CLP regulation No. 1272/2008 concerning classification,
the packing and the labeling of the dangerous substances, the compound
was considered as non-irritant.
Justification for selection of skin irritation / corrosion endpoint:
Key study with Depanol I
Justification for selection of eye irritation endpoint:
Key study
Justification for classification or non-classification
Depanol I does not have to be classified for skin and eye irritation according the EU labelling regulations Commission Directive 93/21/EEC or CLP regulation No. 1272/2008 of 16 December 2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.