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EC number: 422-030-7 | CAS number: 91538-82-8
- 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
Skin irritation (OECD 404, RL1): (female rabbit) The test material revealed a long lasting irritation potential with a remarkable damage of the skin, the test material should be regarded as a corrosive Category 1.
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:
- 17.11.-08.12.2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: about 22 weeks
- Weight at study initiation: 4.29 kg
- Housing: separately in special rabbit cage (manufacturer: Becker; type K99130 KU, floor area about 5400 cm2, a shelter with an integrated sitting board of about 1820 cm2; overall height: 60 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 16 °C
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12/12 hours
IN-LIFE DATES: From: day 1 To: day 22 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- The first examination of the treated skin sites followed 1 hour after removal of the patch. Thereafter, examinations were performed daily for further 21 days.
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100
- Type of wrap if used: self-adhesive fabric
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 1 hour after removal of the patches, and then daily for a period of further 21 days
SCORING SYSTEM:
Skin changes at the application sites were evaluated according to the DRAIZE-, OECD-and EEC recommendations. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 22 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 h
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 22 days
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test material revealed a long lasting irritation potential with a remarkable damage of the skin.
According to the EEC-Directive 1272/2008 the test material should be regarded as a corrosive Category 1. - Executive summary:
Purpose
The purpose of this assay was to identify the skin irritation/corrosion potential of the test material when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.
Study Design
To test for primary skin irritation, 0.5 mL of the test material was spread onto 6 cm2patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was an initial test with one animal. This animal showed signs of irritation (well defined erythema, edema, hardened brittle skin, scabs, epithelization, and scales) and no more animals were treated. The first examination of the treated skin sites followed 1 hour after removal of the patch. Thereafter, examinations were performed daily for further 21 days.
Results
Only one rabbit was used for the study. No signs of pain were observed after administration. Under the conditions of the present study erythema (scores 2 to 4) were observed from experimental day 1 up to the end of the study and edema (score 4) from day 1 up to 3 of the experimental part. Furthermore scabs, hardened brittle skin, peeling off skin, epithelization, and scales from experimental day 4 up to the end of the experimental part were seen.
Individual values of one rabbit
Day
(after treatment)1
(1h)2
(24 h)3
(48h)4
(72 h)Erythema 2 2 2 4 Edema 4 4 4 0
Evaluation of each animal:
Animal No Mean score
(24, 48, 72 h)Maximum value
(24, 48, 72 h)1 1 Erythema 2.67 4 Edema 2.67 4 Conclusion
The test material revealed a long lasting irritation potential with a remarkable damage of the skin.
According to the EEC-Directive 1272/2008 the test material should be regarded as a corrosive Category 1.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
Only 1 rabbit was used for the study. No signs of pain were observed after administration. Under the conditions of the present study erythema (scores 2 to 4) were observed from experimental day 1 up to the end of the study and oedema (score 4) from day 1 up to 3 of the experimental part. Furthermore scrabs, hardened brittle skin, peeling off skin, epithelization, and scales from experimental day 4 up to the end of the experimental part (day 22) were seen.
Day (after treatment) |
1 (1h) |
2 (24 h) |
3 (48h) |
4 (72 h) |
Erythema | 2 | 2 | 2 | 4 |
Edema | 4 | 4 | 4 | 0 |
No signs of clinical toxicity were detected.
Body weight development of the treated rabbit was inconspicuous.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- 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:
- adverse effect observed (irritating)
Additional information
In vivo skin irritation study
To test for primary skin irritation, 0.5 mL of the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was an initial test with one animal. This animal showed signs of irritation (well defined erythema, edema, hardened brittle skin, scabs, epithelization, and scales) and no more animals were treated. The first examination of the treated skin sites followed 1 hour after removal of the patch. Thereafter, examinations were performed daily for further 21 days. The test material revealed a long lasting irritation potential with a remarkable damage of the skin, the test material should be regarded as a corrosive Category 1.
Eye irritation/corrosion
No data on eye irritation/corrosion is available, however, the test item is considered to induce serious eye damage because the test item cause also irreversible damage to the skin.
Respiratory tract irritation
There are currently no validated tests on respiratory tract irritation, however, it is a reasonable precaution to assume that corrosive (and severely irritating) substances would also cause respiratory tract irritation. Since the substance induced serious eye damage, it is assumed as a precautionary measure that the test item cause also respiratory tract irritation.
Justification for classification or non-classification
Based on the reults, the test item is classified for skin irritation category 1 (H314), for eye corrosion category 1 (H318), and STOT SE category 3 (H335) according to Regulation (EC) No 1272/2008.
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