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EC number: 470-470-3 | CAS number: 9022-75-7
- 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
Signs of corrosive effects were observed in a skin irritation study in one New-Zealand white rabbit.
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
- Reliability:
- 2 (reliable with restrictions)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Housing temperature and area of application not reported.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Housing temperature and area of application not reported.
- Principles of method if other than guideline:
- Not applicable
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: After 3 min exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: After 3 min exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: After 4 h exposure
- Other effects:
- A yellow coloration of the skin also observed at the 24 h and 48 h readings after both exposures.
Reference
Table 1: 3-minute exposure - Cutaneous examinations and mean values of the scores
Dermal irritation |
Scores |
Mean irritation score |
|||
|
1 h |
24 h |
48 h |
72 h |
|
erythema |
0 |
0 |
0 |
2 |
0.7 |
oedema |
0 |
0 |
0 |
3 |
1.0 |
other |
none |
Yellow coloration |
Yellow coloration |
none |
|
Table 2: irritation scores for the 14-day observation period after 3-min exposure
Dermal irritation |
Scores |
|||||||||
|
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
erythema |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
oedema |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
other |
none |
none |
Dryness of the skin
|
Dryness of the skin |
Dryness of the skin |
Dryness of the skin |
none |
none |
none |
none |
Table 3: 4-hour exposure - Cutaneous examinations and mean values of the scores recorded for the animal
Dermal irritation |
Scores |
Mean irritation score |
|||
|
1 h |
24 h |
48 h |
72 h |
|
erythema |
1 |
1 |
2 |
Scoringmasked by necrosis |
(2) (not calculated) |
oedema |
0 |
0 |
3 |
4 |
2.3 |
other |
none |
Yellow coloration |
Yellow coloration |
none |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- other justification
- 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 (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a GLP study conducted according to OECD guideline 404, a New-Zealand white rabbit treated with 0.5 mL of Chimexane NV for 4 h showed necrosis associated with a severe oedema on the whole treatment site on Day 4.
According to ANNEX VII column 2 of the REACH regulation, no study was needed to assess eye irritation as Chimexane NV is classified as corrosive.
When taking into account the corrosive properties of CHIMEXANE NV on skin, it is considered that it can cause severe damages to the eye.
Justification for selection of skin irritation / corrosion
endpoint:
Only one study assessing the irritant potential of the substance.
Justification for selection of eye irritation endpoint:
One skin irritation study showing corrosive effects on skin is
available. A waiver is therefore submitted for this endpoint.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
As corrosive effects were observed on the skin of a New-Zealand white rabbit exposed by dermal route to Chimexane NV for 4 h, Chimexane NV is classified as corrosive (C; R34) according to the Directive 67/548/EC and category 1C according to CLP Regulation (EC) N° (1272-2008).
No study for eye irritation was performed; when taking into account the corrosive properties of CHIMEXANE NV on skin, it is considered that it can cause severe damages to the eye.
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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