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Diss Factsheets
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EC number: 276-684-1 | CAS number: 72480-09-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Points 8.1 and 8.2 of Annex VIII of REACH have been amendeded. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 25th of November to the 2th of December, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to internationally accepted guideline.
- Justification for type of information:
- Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Points 8.1 and 8.2 of Annex VIII of REACH have been amendeded. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From the 25th of November to the 2th of December, 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Study conducted according to internationally accepted guideline.
- Justification for type of information:
- Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: Kleintierrarm Madoerin AG, CH 4414 Fuellinsdorf I Switzerland
Age at start of treatment: males: 14 weeks, females: 15 weeks
Body weight at start of treatment: male 2.6, female 2.4-2..8
Identification: by unique cage number and corresponding ear tags
Acclimatization: four days under test conditions after veterinary examination.
HUSBANDRY
Room No.: 138
Standard Laboratory Conditions.
Air-conditioned with 10—15 air changes per hour and hourly monitored environment with temperature 20±3 °C, relative humidity 40—70%, 12 hour, artificial fluorescent light/12 hours dark, music/light period.
AccommodationIndividually in stainless steel cages equipped with an automatic cleaning and drinking system ( Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 0—7830Emmendingen / FRG).
Diet
Pelleted standard Kliba 341, Batch 40/88 rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
Analysis for contaminants have been performed.
Water
Community tap water from Itingen, ad libitum.
Analysis for contaminants have been performed. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test articleThe test article was applied moistened with distilled water. The moistened test article was warmed up to 40° C degrees centigrade and than cooled down again.The vehicle used, was found to be the most qualified to assure an optimum technical application procedure of the test article.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Viability, mortality: daily
Body weight: day 1 of test (application day) and at termination of test on a Mettler PK 16 balance.
The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article. - Number of animals:
- 1 male2 females
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was observed 1 day prior to test article administration.On test day 1, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi—occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the following numerical scoring system.The observation was terminated 72 hours after application of the test article.All rabbits were killed by an intravenous injection of T61 (Hoechst AG) into the ear vein and discarded.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The substance showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
- Other effects:
- In the area or application, a brown staining of the treated skin by pigment or coloring of the test article was observed. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
- Interpretation of results:
- not irritating
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- Non irritant/corrosive for the skin
- Executive summary:
Method
The irritation/corrosion property was tested on the Similar substance 01 according to the OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and the EU Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion), in GLP.
Observations
Under the conditions of this experiment, the substance was found to cause a primacy irritation score of 0.00 when applied to intact rabbit skin.
Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
In the area of application, a brown staining of the treated skin by pigment or coloring of the test article was observed.
No corrosive effect had occurred on the skin at any measuring interval.
Results
According to EEC Council Directive, 83/467/EEC, July 1983 Brussels, Belgium, the mean value of the scores for each type of lesion, calculated ftc each animal separately, is the mean 24:-72 hours: 0.00 score in one male and two females.
Data are summarized in tabular form, showing for each individual animal the irritation scores for erythema and edema at 60 minutes, 24, 48 and 72 hours after patch removal, any lesions, a description or the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed. The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed. The individual scores do not represent an absolute standard for the irritant properties of a material, and they are viewed as reference values. The use of a semi-occlusive dressing is a severe test and the results are not directly comparable to human exposure conditions.
Mean values and standard deviations were calculated whenever possible.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Similar substance 01 of Acid Brown 147
- IUPAC Name:
- Similar substance 01 of Acid Brown 147
- Test material form:
- solid: particulate/powder
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: Kleintierrarm Madoerin AG, CH 4414 Fuellinsdorf I Switzerland
Age at start of treatment: males: 14 weeks, females: 15 weeks
Body weight at start of treatment: male 2.6, female 2.4-2..8
Identification: by unique cage number and corresponding ear tags
Acclimatization: four days under test conditions after veterinary examination.
HUSBANDRY
Room No.: 138
Standard Laboratory Conditions.
Air-conditioned with 10—15 air changes per hour and hourly monitored environment with temperature 20±3 °C, relative humidity 40—70%, 12 hour, artificial fluorescent light/12 hours dark, music/light period.
AccommodationIndividually in stainless steel cages equipped with an automatic cleaning and drinking system ( Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 0—7830Emmendingen / FRG).
Diet
Pelleted standard Kliba 341, Batch 40/88 rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) ad libitum.
Analysis for contaminants have been performed.
Water
Community tap water from Itingen, ad libitum.
Analysis for contaminants have been performed.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test articleThe test article was applied moistened with distilled water. The moistened test article was warmed up to 40° C degrees centigrade and than cooled down again.The vehicle used, was found to be the most qualified to assure an optimum technical application procedure of the test article.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Viability, mortality: daily
Body weight: day 1 of test (application day) and at termination of test on a Mettler PK 16 balance.
The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article. - Number of animals:
- 1 male2 females
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was observed 1 day prior to test article administration.On test day 1, 0.5 g of the test article was applied to approx. 6 cm2 of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi—occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the following numerical scoring system.The observation was terminated 72 hours after application of the test article.All rabbits were killed by an intravenous injection of T61 (Hoechst AG) into the ear vein and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The substance showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.
- Other effects:
- In the area or application, a brown staining of the treated skin by pigment or coloring of the test article was observed. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
Any other information on results incl. tables
Data are summarized in tabular form, showing for each individual animal the irritation scores for erythema and edema at 60 minutes, 24, 48 and 72 hours after patch removal, any lesions, a description or the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed. The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed. The individual scores do not represent an absolute standard for the irritant properties of a material, and they are viewed as reference values. The use of a semi-occlusive dressing is a severe test and the results are not directly comparable to human exposure conditions.
Mean values and standard deviations were calculated whenever possible.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- Non irritant/corrosive for the skin
- Executive summary:
Method
The irritation/corrosion property was tested on the substance according to the OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and the EU Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion), in GLP.
Observations
Under the conditions of this experiment, the substance was found to cause a primacy irritation score of 0.00 when applied to intact rabbit skin.
Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
In the area of application, a brown staining of the treated skin by pigment or coloring of the test article was observed.
No corrosive effect had occurred on the skin at any measuring interval.
Results
According to EEC Council Directive, 83/467/EEC, July 1983 Brussels, Belgium, the mean value of the scores for each type of lesion, calculated ftc each animal separately, is the mean 24:-72 hours: 0.00 score in one male and two females.
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.
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