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EC number: 948-085-1 | CAS number: -
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24. Apr. 2007 - 31. Aug. 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals, Section 4, number 404 "Acute Dermal lrritation 1 Corros ion", adopted April 24, 2002.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Commission Directive 2004/73/EC, B.4. "Acute Toxicity: Dermal lrritatíon/Corrosion", April 29, 2004.
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 2001/59/EC
- Version / remarks:
- Commission Directive 2001/59/EC of 6 August 2001, Annex VI
- GLP compliance:
- yes
Test material
- Reference substance name:
- Copper di-D-gluconate
- EC Number:
- 208-408-2
- EC Name:
- Copper di-D-gluconate
- Cas Number:
- 527-09-3
- Molecular formula:
- C12H22CuO14
- IUPAC Name:
- copper(2+) bis(2,3,4,5,6-pentahydroxyhexanoate)
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- H2O4S.2Na
- IUPAC Name:
- disodium sulfate
- Reference substance name:
- Copper sulphate
- EC Number:
- 231-847-6
- EC Name:
- Copper sulphate
- Cas Number:
- 7758-98-7
- Molecular formula:
- CuSO4
- IUPAC Name:
- copper(2+) ion sulfate
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Test system: Young Adult New Zealand White Rabbit
- Rationale: Recognized by the international guidelines as the recommended test system.
- Source: Granja San Bernardo, Ctra. de Tarazona, s/n, 31522-Tulebras, Navarra {Spain)
- Total number of animals: 3
- Sex: Males
- Body weight at start of treatment: 2.5-3.0 kg
- ldentification: By numbered tags in the ears.
- Acclimatization: From 14 to 28 days.
- Veterinary inspection: During acclimatization the animals were examined by a veterinary surgeon to assure their satisfactory health status for use in the study.
HUSBANDRY
- Room number: Room 107
- Conditions: Standard Laboratory Conditions
Air-conditioned with ranges for room temperatura 21-23 °C, relative humidity 40-70% and 10-20 air changes per hour. Room temperatura and relatíve humidity were monitored contínuously. Values outside these ranges occurred but only for short periods. These transient variatíons are considerad not to have any influence on the study and therefore these data are not reported but are retained at RCC CIDA S.A. There was a 12-hour fluorescent light/12-hour dark cycle.
- Accommodation: lndividually in stainless steel cages (52 x 58 x 43 cm).
The cages were identified by a card stating the animal's number, sex and date of arrival, Study Number, Study Director's name, test item identification, dose level,
administration route, and date of treatment.
- Diet: Pelleted standard TEKLAD 2030 Global Rabbit diet was offered ad libitum (supplied by Harlan lnterfauna Ibérica, S.L, Ctra. Sant Miquel del Fai, Km. 3, 08182-Sant Feliu de Codines, Barcelona, Batch No. N495 and N516, Expiry Date: 4 and 26 June 2007) was offered ad libitum. Results of analyses for contaminants are archivad at RCC CIDA S.A.
- Water: Tap water ad libitum by means of an automatic drinking system. Results of bacteriological, chemical and contaminant analyses are archivad at RCC CIDA S.A.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- The test item was administered 0.5 mL/animal, the dose specified in the test guidelines for a liquid test item.
- Duration of treatment / exposure:
- The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
- Observation period:
- ONBSERVATIONS
- Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
- Clinical signs: Daily during the acclimatization, on the day of application and in each observation time point.
- Body weights: At start of acclimatization, on the day of application and in each observation time point.
- Skin reaction: See sections 4.7 and 4.8. - Number of animals:
- Three young adult New Zealand White rabbits.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 2812
- Time point:
- other: 1h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 2817
- Time point:
- other: 1h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 2819
- Time point:
- other: 1h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 2812
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 2817
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 2819
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 2812
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 2817
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 2819
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 2812
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 2817
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 2819
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 2819
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 2812
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 2817
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 2812
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 2817
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 2819
- Time point:
- 48 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 2812
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 2817
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 2819
- Time point:
- 72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- SKIN OBSERVATION TIME POINTS AND TERMINATION
The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after exposure (removal of the dressing, gauze patch and test item).
IRRITATION
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and edema for each of the three animals was therefore 0.
No abnormal findings were observed on the treated skin of any animal 72 hours after treatment, the end of the observation time. - Other effects:
- VIABILITY/MORTALITY/CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
COLORATION
No staining produced by the test item of the treated skin was observed.
CORROSION
Neither alterations of the treated skin were observed nor were corrosiva effects evident on the skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item do not classified as Skin Irrit.
- Executive summary:
The primary skin irrítatíon potential of the test item was investigated according to OECD test guideline no. 404. The test ítem was applied by topical semi-occlusive application of 0.5 ml to
the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and edema for each of the three animals was therefore 0.
The application of the test item to the skin resultad in no signs of irritation. The test ítem caused no staining of the treated skin. No corrosiva effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce damage to the skin.
Based upon the referred classification criteria (Commission Directiva 2001/59/EC of August 2001 ), SERGOMIL L60 is considerad to be "not irritating" to rabbit skin and, therefore, it is not necessary to assign it a risk phrase.
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