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EC number: 229-942-2 | CAS number: 6850-63-1
- 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
Corrosive to the skin. As the substance is corrosive to the skin it is concluded the the substance is also corrosive to the eye.
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)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period only 1 h but necrosis was obvious; occlusive coverage conditions). The study is sufficient for evaluation.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only 3 min and 1 h exposure
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.92-3.73 kg
- Housing: single
- certified diet (ad libitum)
- tap water (ad libitum):
- Acclimation period: 8 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- The test patch (2 .5 x 2 .5 cm) loaded with the test substance and applied to the dorsal skin; amount: ca. 0.5 ml
- Duration of treatment / exposure:
- 1) 3 minutes
2) 1 hour - Observation period:
- 30-60 minutes after removal of the test patch and 24, 48, and 72 h after initiation of exposure
- Number of animals:
- 1) n=6
2) n=3 - Details on study design:
- Washing of test site after removal of test patch with Lutrol or water/Lutrol.
Scoring according to Draize 1959 (comparable with OECD 404)
Histopathological verification of readings - Irritation parameter:
- erythema score
- Remarks:
- (exposure duration 3 minutes)
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 3.72
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: necrosis of skin in all 6 rabbits; more pronounced effects after 24 h exposure
- Irritation parameter:
- edema score
- Remarks:
- (exposure duration 3 minutes)
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Remarks:
- / (expsure duration 1 hour
- Basis:
- mean
- Remarks:
- / of 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: necrosis of skin in all 6 rabbits; more pronounced effects after 1 h exposure
- Irritation parameter:
- edema score
- Remarks:
- / (exposure duration 1 hour
- Basis:
- mean
- Remarks:
- / of 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Irritant / corrosive response data:
- 1) exposure duration 3 minutes
necrosis detected in 4/6 rabbits 24 h after exposure; oedema max. score 2
1) exposure duration 1 h
Necrosis in all 3 rabbits found 30-60 min after exposure period
Necrosis in all animals verified in macroscopic pathology. - Other effects:
- no data
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- In skin irritation studies in rabbits the undiluted test substance resulted in corrosive effects.
- Executive summary:
The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; occlusive coverage conditions). The study is sufficient for evaluation.
Six rabbits received dermal application of 0.5 ml undiluted test substance under occlusive dressing in two experiments; the exposure time was 3 minutes and 1 h in the first experiment and 3 minutes only in the second experiment (followed by washing each). Scorring of skin irritation according to Draize was performed up to 60 minutes and 24, 48, and 72 h after removal of the patch.
In the 1st experiment (3 minutes and 1 h exposure) erythema score of 4 and necrosis of the skin was obvious within 1h after exposure (1h treatment) and 24 h after exposure (3 minutes and 1 h treatment) and in the 2nd experiment (3 minutes expousre) again after the 24 h reading.
Conclusion: In skin irritation studies in rabbits the undiluted test substance resulted in corrosive effects even after a short exposure period of 3 minutes (24 h post-exposure).
Reference
Skin irritation in rabbits after an exposure duration of 3 minutes or 1 hour
Scorring |
Erythema mean score |
Edema mean score |
Necrosis detected |
Exposure duration 3 minutes |
|
|
|
1rabbit |
3 |
2 |
No |
2rabbit |
3 |
2 |
No |
3rabbit |
3 |
2 |
No |
4rabbit |
3 |
2 |
No |
5rabbit |
2 |
1 |
No |
6rabbit |
3 |
2 |
No |
24 h after initiation |
|
|
|
1rabbit |
4 |
2 |
Yes |
2rabbit |
4 |
2 |
Yes |
3rabbit |
3 |
2 |
No |
4rabbit |
4 |
2 |
Yes |
5rabbit |
2 |
1 |
No |
6rabbit |
4 |
2 |
Yes |
48 h after initiation |
|
|
|
1rabbit |
4 |
2 |
Yes |
2rabbit |
4 |
2 |
Yes |
3rabbit |
4 |
2 |
Yes |
4rabbit |
4 |
1 |
Yes |
5rabbit |
2 |
2 |
No |
6rabbit |
4 |
2 |
Yes |
72 h after initiation |
|
|
|
1rabbit |
4 |
1 |
Yes |
2rabbit |
4 |
1 |
Yes |
3rabbit |
4 |
1 |
Yes |
4rabbit |
4 |
1 |
Yes |
5rabbit |
4 |
2 |
Yes |
6rabbit |
4 |
2 |
Yes |
Scorring |
Erythema mean score |
Edema mean score |
Necrosis detected |
Exposure duration 1 hour |
|
|
|
1rabbit |
4 |
2 |
Yes |
2rabbit |
4 |
2 |
Yes |
3rabbit |
4 |
2 |
Yes |
24 h after initiation |
|
|
|
1rabbit |
4 |
2 |
Yes |
2rabbit |
4 |
2 |
Yes |
3rabbit |
4 |
2 |
Yes |
48 h after initiation |
|
|
|
1rabbit |
4 |
2 |
Yes |
2rabbit |
4 |
2 |
Yes |
3rabbit |
4 |
2 |
Yes |
72 h after initiation |
|
|
|
1rabbit |
4 |
1 |
Yes |
2rabbit |
4 |
1 |
Yes |
3rabbit |
4 |
1 |
Yes |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; occlusive coverage conditions). The study is sufficient for evaluation.
Six rabbits received dermal application of 0.5 ml undiluted test substance under occlusive dressing in two experiments; the exposure time was 3 minutes and 1 h in the first experiment and 3 minutes only in the second experiment (followed by washing each). Scorring of skin irritation according to Draize was performed up to 60 minutes and 24, 48, and 72 h after removal of the patch.
In the 1st experiment (3 minutes and 1 h exposure) erythema score of 4 and necrosis of the skin was obvious within 1h after exposure (1h treatment) and 24 h after exposure (3 minutes and 1 h treatment) and in the 2nd experiment (3 minutes expousre) again after the 24 h reading.
Conclusion: In skin irritation studies in rabbits the undiluted test substance resulted in corrosive effects even after a short exposure period of 3 minutes (24 h post-exposure).
Eye irritation:
As the substance is corrosive to the skin and further more the results
of the acute inhalation test reported in section 7.2.2 suggested lesions
of the cornea by saturated vapour at 20°C. There is no need for further
testing of eye irritation.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for skin irritation cat.1A and eye irritation cat.1 under Regulation (EC) No. 1272/2008.
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