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EC number: 419-330-5 | 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:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study performed under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- 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
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: FAT 40543/A
Description: Red powder
Batch: TV RN 196-200
Purity: 90%
Test substance storage conditions: At room temperature in the dark
Stability under storage: Stable
Expiry date: November 01, 2000
Stability in vehicle Water: not indicated
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: Albino Rabbit, New Zealand White, (SPF-Quality), Source: Broekman Institute, Someren, The Netherlands.
Number of animals: 3 male rabbits
Age at start of treatment: Approx. 7 weeks
Body weight at start of treatment: 1401 - 1510 grams
Identification: Ear tag.
ANIMAL HUSBANDRY
Conditions: Air-conditioned room with approximately 15 air changes per hour and the environment controlled with optimal conditions considered as being a temperature of 21 °C and a relative humidity of 50%. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Accommodation: Individually in labelled cages with perforated floors (Scanbur Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 gram per day. Certificates of analysis were examined and retained in the NOTOX archives. In addition, hay (BMI, Helmond, The Netherlands) was provided once a week.
Water: Free access to tap-water diluted with decalcified water. Certificates of analysis were examined and retained in the NOTOX archives.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: The powdery test substance was moistened with distilled water.
- Controls:
- no
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- terminated after 7 days as all scores were 0.
- Number of animals:
- 3
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm ²).
The animals were examined, and the skin to be treated in particular, prior to test substance administration and no abnormalities were detected. On test day 1, 0.5 grams of the test substance was moistened (The 0.5 grams was moistened with 2 ml of distilled water, to obtain a mixture that was suitable for application) and subsequently applied to the intact skin of the clipped area on one flank, using a Scotchpak-non-woven patch (Supplier, 3M, St. Paul, U.S.A.) of 2x3 cm. A similar patch (but without test substance and water) was applied to the contralateral flank, to act as a procedural control. Both patches were mounted on Micropore tape*, which was wrapped around the abdomen and secured with Coban elastic bandage.
Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue. Whenever considered necessary the skin areas concerned of the animals were re-clipped and/or washed with moistened tissues at least 3 hours before the observations, to facilitate the scoring.
Based on the results obtained in this study and after consultation with the sponsor, the study was repeated. In this repeat, the skin of the rabbits was cleaned by depilation after exposure to the test substance in order to facilitate scoring. This study (NOTOX project 171056) is reported in the Appendix.
OBSERVATIONS
Mortality/Viability: Twice daily
Toxicity: At least once daily.
Body Weight: Day of treatment (prior to application).
Irritation : The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and 7 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.
The skin reactions were graded according to the following numerical 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): 4 (In case of signs of necrosis or corrosion (injuries in depth) preventing erythema reading, the maximum grade for erythema (= 4) is given)
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 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
INTERPRETATION OF RESULTS
The irritation scores and all other observations were transcribed for compilation and analysis.
The individual scores for erythema and oedema are summarised in tabular form.
A primary irritation index was calculated (the sum of the irritation scores for erythema and oedema obtained at 24 and 72 hours after exposure, divided by 2 times the number of animals used in the study). With the primary irritation index a degree of irritation was obtained, using the table described below (based on Draize et.al. (1944) J.Pharmacol .Exp. 82, 377):
Primary irritation index Degree of irritation
0: non-irritating
> 0 - 0.4: negligibly irritating
>0.4 - 2.0: mildly irritating
>2.0 - 5.0: moderately irritating
>5.0 - 8.0: severely irritating
Note: Where the scoring procedure and the clinical judgement were not in agreement, the assessment of irritancy was based on the latter.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: scoring was hardly possible due to red staining but deduced from the preliminary test in the skin sensitisation study in which the skin was depilated prior to treatment
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: scoring was hardly possible due to red staining but deduced from the preliminary test in the skin sensitisation study in which the skin was depilated prior to treatment
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: scoring was hardly possible due to red staining but deduced from the preliminary test in the skin sensitisation study in which the skin was depilated prior to treatment
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: scoring was hardly possible due to red staining but deduced from the preliminary test in the skin sensitisation study in which the skin was depilated prior to treatment
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 7 days following treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Due to the absence of available scores for erythema during the first 72 hours of the study, no primary irritation index could be calculated. A repeat of the study, in which the skin was cleaned after exposure to the test substance by depilation, also allowed no conclusion to be drawn, since comparable reactions were observed in the test substance treated skin area and the control site. These reactions were considered to be caused by the depilation procedures. For the sensitisation study with the same substance (NOTOX project 162258), a preliminary irritation test was carried out in guinea pigs. In this test, to remove the staining caused by the test substance and to facilitate scoring, the treated skin was depilated. The results obtained indicate that no irritation was caused by similar concentrations of FAT40543/A after an exposure period of 24 hours. Based on the results obtained in this study and in the preliminary irritation test of the sensitisation study with the same test substance, it is concluded that no irritation is caused by FAT40543/A after 4 hours of exposure. However, red staining of the skin occurred, which persisted for at least 7 days after exposure.
- Other effects:
- Red staining of the treated skin was observed throughout the 7 day observation period. No oedema were observed. No erythema were observed on day 7.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- FAT40543/A was shown to be non-irritant to rabbit skin. However, red staining of the skin was noted for 7 days.
- Executive summary:
The study was carried out in accordance with the OECD guideline No. 404, 'Acute Dermal Irritation/Corrosion' and the EEC Directive 92/69/EEC, B.4, 'Acute Toxicity - Skin irritation.
Three rabbits were exposed to 0.5 grams of FAT40543/A, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours and 7 days after exposure. Exposure to FAT40543/A resulted in red staining of the treated skin, and hence scoring for erythema was made impossible for the first 72 hours after application. No erythema was observed at the observation 7 days after exposure. No oedema was observed during the study. No signs of systemic intoxication were observed during the study period. Due to the absence of available scores for erythema during the first 72 hours of the study, no primary irritation index could be calculated. A repeat of the study, in which the skin was cleaned after exposure to the test substance by depilation, also allowed no conclusion to be drawn, since comparable reactions were observed in the test substance treated skin area and the control site. These reactions were considered to be caused by the depilation procedures. For the sensitisation study with the same substance (NOTOX project 162258), a preliminary irritation test was carried out in guinea pigs. In this test, to remove the staining caused by the test substance and to facilitate scoring, the treated skin was depilated. The results obtained indicate that no irritation was caused by similar concentrations of FAT40543/A after an exposure period of 24 hours. Based on the results obtained in this study and in the preliminary irritation test of the sensitisation study with the same test substance, it is concluded that no irritation is caused by FAT40543/A after 4 hours of exposure. However, red staining of the skin occurred, which persisted for at least 7 days after exposure.
CORROSION: There was no evidence of a corrosive effect on the skin
COLOURATION: Red staining of the treated skin by the test substance was observed.
TOXICITY SYMPTOMS / MORTALITY: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
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