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EC number: 237-855-6 | CAS number: 14024-48-7
- 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 value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-05-16 to 2006-05-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Minor deviations with no effects on the study: - According to the guideline, for the initial test in one animal, the test site is also examined immediately after the patch has been removed. In this study report there was no statement indicating if this was done. - According to the guideline a rationale for in vivo testing should be stated in the study report. This is missing in this study report. - According to the guideline, the individual animal weights at the start and at the conclusion of the test should be stated. In this study report only a mean body weight with standard deviation was stated, which only indicated the mean body weight at the beginning of the study.. - According to the guideline, in the test report the volume of vehicle used should be stated. This was missing in this study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- yes
- Remarks:
- Minor deviations with no effect on the study (see rationale for reliability)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: On the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: On the day of treatment, the animals had a mean body weight +/- standard deviation of 2.5 +/- 0.1 kg
- Housing: The animals were housed individually in Pajon (50 cm X 57 cm X 75 cm) cages. Each cage was equipped with a food container and a water bottle.
- Diet: During the study, the animals had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Relative humidity: 30 to 70 %
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test item
No further information on amount/concentration applied was stated. - Duration of treatment / exposure:
- One animal : 3 minutes, 1 hour and 4 hours
Other animals: 4 hours - Observation period:
- Observation period was 1 hour, 24, 48 and 72 hours after removal of the dressing. The study was ended on day 4.
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
The day before treatment, both flanks of each animal were clipped using electric clippers. Doses of 500 mg of the test item in its original form were placed on a gauze pad moistened with purified water, which was then applied to an area of approximately 6 cm^2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wiped off by means of a dry cotton pad.
SCORING SYSTEM:
Draize scoring system
No further information on details on study design was stated. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No erythema was observed.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No oedema was observed.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal # 2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No oedema was observed.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal # 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No erythema was observed.
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No oedema was observed.
- Irritant / corrosive response data:
- After a 3 minute exposure (one animal):
No cutaneous reactions were observed.
After 1 hour exposure (one animal)
An orange colouration of the skin was noted at 1 hour and at 24 hours.
After a 4 -hour exposure (three animals):
A very slight erythema (grade 1 ) was noted in 2/3 animals at one hour; it persisted in one of them at 24 hours.
An orange colouration of the skin was observed in 2/3 animals at 1 hour. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the test item Peconal H was very slightly irritant when applied topically to rabbits.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not irritating.
Reference
Raw data for 3 -minute exposure:
Rabbit No. |
Dermal irritation |
1 hour |
24 hours |
48 hours |
72 hours |
Mean irritation score (24 h, 48 h, 72h) |
1 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Raw data for 1 hour-exposure:
Rabbit No. |
Dermal irritation |
1 hour |
24 hours |
48 hours |
72 hours |
Mean irritation score (24 h, 48 h, 72h) |
1 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Raw data for 4 hour-exposure:
Rabbit No. |
Dermal irritation |
1 hour |
24 hours |
48 hours |
72 hours |
Mean irritation score (24 h, 48 h, 72h) |
1 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
2 |
Erythema |
1 |
1 |
0 |
0 |
0.3 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
3 |
Erythema |
1 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-05-23 to 2006-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Minor deviations without an effect on the study: - According to the guideline a rationale for in vivo testing should be stated in the study report. This is missing in this study report. - According to the guideline, the individual body weight at start and conclusion of the the test should be stated. The body weight at the conclusion of the test is missing. - In the Draize scoring system referes conjunctival redness to palpebral and bulbar conjunctivae and excludes cornea and iris. In this study cornea and iris are included in the scoring system.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- yes
- Remarks:
- Minor deviations with no effect on the study (see rationale for reliability)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: On the day of treatment, the animal was 2 to 4 months old
- Weight at study initiation: 2.7 kg
- Housing: The animal was housed in Pajon cage (50 cm X 57 cm X 75 cm) equipped with a food container and a water bottle.
- Diet: During the study, the animal had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Relative humidity: 30 to 70 %
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated. - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item in its original form
No further information on amount/concentration applied was stated. - Duration of treatment / exposure:
- not stated
- Observation period (in vivo):
- The eyes were examined approximately 1 hour and 24 hours after administration of the test item. As severe irritant effects were observed, the animal was scarificed on day 2 (after scoring) for ethical reasons.
- Number of animals or in vitro replicates:
- 1 male rabbit
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes were not rinsed after administration of the test item.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Conjucntival reactions, iritis and corneal opacification were evaluated daily for each animal. For evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution ( a clear fluorscence is visible in the area of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.
No further information in details on study design was stated. - Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons on day 2 (after scoring).
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring).
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring).
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring).
- Irritant / corrosive response data:
- A severe chemosis (maximal grade of 4), a severe redness of the conjunctiva (maximal grade of 3) and a clear discharge were observed on days 1 and 2.
The evaluation of iris and corneal lesions was masked by severe chemosis.
A brownish area on the conjunctivae, similar to a burn, was noted on day 2.
Due to the severe ocular reactions observed, the animal was sacrificed for ethical reasons at 24 hours (after scoring). - Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Conclusions:
- Under the experimental conditions, the test item Peconal H was severly irritant when administered by ocular route to rabbits.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 1.
Reference
Raw data of one animal examined at 1 hour and 24 hours.
Rabbit No. |
Region of eye |
Eye irritation |
1 hour Day 1 |
24 hours Day 2 |
1 |
Conjunctivae |
Chemosis |
4 |
4 |
Redness |
3 |
3 |
||
Discharge |
2 |
3 |
||
Iris |
|
Scoring masked by marked chemosis |
Scoring masked by marked chemosis |
|
Corneal opacity |
Intensity |
Scoring masked by marked chemosis |
Scoring masked by marked chemosis |
|
Area |
Scoring masked by marked chemosis |
Scoring masked by marked chemosis |
||
|
Other |
|
Residual test item |
Brownish area on conjunctiva |
|
Fluorescein |
|
Fluorescein not used |
Fluorescein not used |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Key study
Justification for selection of eye irritation endpoint:
Key study
Effects on eye irritation: corrosive
Justification for classification or non-classification
Skin irritation
The reference Pelcot (2007) is considered as the key study for skin irritation and will be used for classification.Cobalt(II) 4-oxopent-2-en-2-olatewas very slightly irritant when applied topically to rabbits. The classification criteria according to regulation (EC) 1272/2008 as irritant to skin are not met, hence no classification required.
Eye irritation
The reference Pelcot (2007) is considered as the key study for severe eye irritation and will be used for classification. The overall irritation results 1 and 24 hours after application for the animal are as follows:
- severe chemosis (maximal grade of 4)
- severe redness of the conjunctiva (maximal grade of 3)
- clear discharge were observed on days 1 and 2
- evaluation of iris and corneal lesions was masked by severe chemosis
- brownish area on the conjunctivae, similar to a burn, was noted on day 2
The classification criteria acc. to regulation (EC) 1272/2008 as irritating to eyes are met, since in the animal severe ocular reactions were not reversible (the animal was sacrificed for ethical reasons at 24 hours). Cobalt(II) 4-oxopent-2-en-2-olate will be classified eye damage category 1 (H318: Causes serious eye damage).
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