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EC number: 203-402-6 | CAS number: 106-48-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- 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 (Category 1, 1A, 1B or 1C)
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1980 to June 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Test procedure performed in accordance with generally accepted scientific standards and well documented. Applicant assessment indicates that any deviation from current published guidelines would not be sufficient to affect the study outcome.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: unspecified
- Weight at study initiation: 3 - 4 kg
- Housing: Individually housed in rabbit cages.
- Diet: Standard mixed rabbit feed, ad libitum.
- Water: Water, ad libitum.
- Acclimation period: Time not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Unspecified
- Humidity (%): Unspecified
- Air changes (per hr): Unspecified
- Photoperiod: Unspecified - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Test material was used as supplied. - Duration of treatment / exposure:
- 1 or 8 hours
- Observation period:
- Immediately after treatment and for the following 7 days.
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: semi-occlusive (2.5 cm x 2.5 cm surgical gauze patch secured with surgical adhesive tape)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not specified; irrigation with water, soap and cotton wool mentioned elsewhere in the test report.
- Time after start of exposure: Not specified; immediate irrigation mentioned elsewhere in the test report.
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema _________________________________________________________________________0
Very slight erythema (barely perceptible) ________________________________________________1
Well-defined erythema ________________________________________________________________2
Moderate to severe erythema __________________________________________________________3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ________________4
Oedema Formation
No oedema __________________________________________________________________________0
Very slight oedema (barely perceptible) _________________________________________________1
Slight oedema (edges of area well-defined by definite raising) _____________________________2
Moderate oedema (raised approximately 1 millimetre) ____________________________________3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) ___4
Any other skin reactions and clinical signs of toxicity, if present, were also recorded. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: All observations
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- Score is applicant assessment based on written description in study report.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: All observations
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 0 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- positive indication of irritation
- Remarks:
- Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 0 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- positive indication of irritation
- Remarks:
- Score is applicant assessment based on written description in study report.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- Score is applicant assessment based on written description in study report.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- positive indication of irritation
- Remarks:
- Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score is applicant assessment based on written description in study report.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Score is applicant assessment based on written description in study report.
- Irritant / corrosive response data:
- - Erythema: "Severe reddening with partial skin corrosion" (applicant assessment: severe erythema, score = 4) apparent immediately upon removal of bandage, persisting for the duration of the observation period, at both test sites.
- Edema: "Slightly swollen skin" (applicant assessment: Slight edema, score = 2) observed in both sites, immediately upon removal of bandage, with effects fully-reversed within 48 hours.
- Reversibility of effects: Erythema did not reverse during the observation period; oedema reversed within 48 hours. - Other effects:
- There was no clinical signs of toxicity reported during the duration of the test, and no comments are recorded regarding bodyweight for these rabbits.
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item is considered very strongly irritating and corrosive to the skin.
- Executive summary:
The study was performed historically to a documented method similar to OECD TG 404 and EU Method B.4, to assess the primary skin irritancy potential of the test item in New Zealand White rabbits, following single 1 or 8 -Hour, semi-occluded applications to intact rabbit skin. Applicant assessment indicates that any deviation from current guidelines would be insufficient to affect the study outcome. 0.5 g of the test item was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the clipped skin to assess the irritancy potential of the test item. The patch was secured in position with a strip of surgical adhesive tape. After 1 or 8 hours of exposure to the test item (1 treatment/exposure-period per rabbit), the patches were removed and individual dose sites were observed immediately and over the following 7 days. A single, semi occluded application of the test item, of either 1 or 8 hours, to the intact skin of two rabbits produced severe erythema and partial corrosion immediately at the two treated skin sites, which did not reverse during the study. Slight erythema was detected immediately after patch removal in both sites, which was fully reversed within 48 hours. Corrosive effects were noted. Mean scores for following grading between 0 hours and 7 days were 4 and 4 in erythema and eschar scoring criteria; mean scores for following grading between 0 hours and 48 hours were 2 in edema scoring criteria; mean scores for following grading from 48 hours to 7 days were 0 in edema scoring criteria. The study authors note "Aufgrund der stark ausgepraegten Reiz- und Aetzwirkung ist jedoch jeder Haut- und Schleimhautkontakt (Auge) mit dem Pruefmuster unbedingth zu vermeiden.", i.e. "Due to the pronounced irritant and caustic effect, any skin and mucous-membrane contact (eye) with the test item must be avoided." Furthermore, the authors note, "...jeglicher Haut- und Schleimhautkontakt (Auge) ist unbedingt zu vermeiden.", i.e. "any contact with skin or mucous membranes (eye) should be avoided at all costs". Under the conditions of the study, the test item is therefore considered to be a strong skin irritant and skin corrosive.
The study report provides written description of the reaction of the animals' skin to the test item. Applicant assessment of the written description indicates the following scores:
Table 1. Individual skin reactions
Skin Reaction | Observation Time (following patch removal) |
Individual Scores | ||
Number and Sex | ||||
#1 (male) | #2 (female) | |||
Erythema/Eschar Formation | 0 Hours | 4 | 4 | |
Intermediate observations | 4 | 4 | ||
48 Hours | 4 | 4 | ||
7 days | 4 | 4 | ||
Edema Formation | 0 Hours | 2 | 2 | |
Intermediate observations | 2 | 2 | ||
48 Hours | 2 | 2 | ||
7 days | 0 | 0 |
Mean scores (N=2) per organism at 0 -48h and 7d:
0 -48h:
Erythemea/Escar Formation:
1: 4
2: 4
Edema Formation:
1: 2
2: 2
7d:
Erythemea/Escar Formation:
1: 4
2: 4
Edema Formation:
1: 0
2: 0
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Results and discussion
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.
- Executive summary:
In accordance with REACH Regulation (EC) 1907/2006 as amended: Annex VII, section 8.3: the in chemico or in vitro / ex vivo study does not need to be conducted based on existing data sufficient for classification and labelling being already available. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.3, July 2017) the study does not need to be conducted. An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin irritation / skin corrosion study performed in 1981 are available, indicating that the substance should be classified as skin corrosion (Category 1, 1A, 1B or 1C) (carried out before 11 October 2016). The study is therefore scientifically not necessary, as other information is available.
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.