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EC number: - | 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:
- 23 April - 14 June 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted under GLP in accordance with the international guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: “Regulation on Test Methods for Chemical Substances” Notification No. 2017-4, National Institute of Environmental Research, Republic of Korea
- Version / remarks:
- 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Storage condition of test material: At room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Controls:
- other: Untreated site
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours plus additional observation until day 4
- Number of animals:
- 3
- Details on study design:
- In the initial test, two sites of one rabbit’s clipped back along the midline were selected as application sites. One site was designated as test substance site. The other site was served as control site. 0.5 g of test substance was placed on the test substance site, moistened with water for injection and held in contact with the skin by a semi-occlusive dressing for 4 hours. No severe irritant effect was observed in the initial test, thus a confirmatory test was conducted using two additional animals. The observation of application sites for skin response was conducted at 1, 24, 48 and 72 hours after patch removal and the skin response scored according to the ‘Evaluation of skin reactions (Method of Draize: 1959)1)’. The degree of skin irritation was classified according to the Draize’s method).In both the initial and confirmatory tests, skin irritation was observed at 72 hours after patch removal. Therefore, additional dermal observations were conducted until Day 4.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 hr and 4 days
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- other: irritation
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- other: irritant
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- other: irritant
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- other: irriatnt
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- other: irritant
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- other: irritant
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- other: irritant
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- The substance is not corrosive but slightly irritating
Any other information on results incl. tables
Table 3. Irritation scores
Applied area |
Group |
Animal ID |
Score of erythema and eschar/Score of edema Intervals (hour) |
Score of erythema and eschar/Score of edema Intervals |
IndividualP.I.I.a) |
P.I.I.b) |
Classification of skin irritation |
||||
1 |
24 |
48 |
72 |
4 |
|||||||
100% test Item |
Initial |
1101 |
0/0 |
1/0 |
1/0 |
1/0 |
0/0 |
0.8 |
0.8 |
Slightly irritant |
|
Confirmatory |
1102 |
0/0 |
1/0 |
1/0 |
1/0 |
0/0 |
0.8 |
||||
1103 |
0/0 |
1/0 |
1/0 |
1/0 |
0/0 |
0.8 |
|||||
Control (only patch) |
Initial |
1101 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0.0 |
Non irritant |
|
Confirmatory |
1102 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
||||
1103 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
hour: Observation after patch removal
a: Individual P.I.I.(Primary skin irritation index) was determined by dividing the total scores of reactions for erythema and eschar/edema formation observed at 1, 24, 48 and 72 hours after patch removal by 4.
b: P.I.I. was determined by dividing the totaled individual P.I.I. by 3 animals to obtain the average
Table 4. Body weights
Applied area |
Group |
Animal ID |
Body weight (kg/day) |
Gain (kg) |
|
1 |
4 |
|
|||
G1 |
Initial |
1101 |
2.05 |
2.16 |
0.11 |
Confirmatory |
1102 |
2.06 |
2.18 |
0.12 |
|
1103 |
2.19 |
2.30 |
0.11 |
||
Mean |
2.10 |
2.21 |
0.11 |
||
SD |
0.08 |
0.08 |
0.01 |
||
N |
3 |
3 |
3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of the study, the primary irritation index (PII) of the test item was 0.8, following exposure to clipped rabbit skin under semi-occlusive condition. Therefore the test item does not meet the criteria for classification according to the Globally Harmonized Classification System or the criteria for classification under the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
OECD 404 (2018): The irritant or corrosive effects of the test item, was assessed following application to the clipped skin of white New Zealand rabbit. 0.5 g of test item was placed on the test substance site, moistened with water for injection and held in contact with the skin by a semi-occlusive dressing for 4 hours. No severe irritant effect was observed in the initial test, thus a confirmatory test was conducted using two additional animals. The observation of application sites for skin response was conducted at 1, 24, 48 and 72 hours after patch removal and the skin response scored according to the ‘Evaluation of skin reactions (Method of Draize: 1959)’. The degree of skin irritation was classified according to the Draize’s method. In both the initial and confirmatory tests, skin irritation was observed at 72 hours after patch removal. Therefore, additional dermal observations were conducted until Day 4.
Animals were observed for mortality, toxicological and pharmacological effects at least once daily. Body weights were recorded pre-test and at termination.
No adverse signs were observed in any animal throughout the course of the study. All animals exhibited normal body weight gain. The mean body weight gain throughout the observation period was 0.11 kg.
The test item sites did not reveal any sign of adverse skin reactions such as erythema and edema in any of three animals at one hour after patch removal. Erythema of score 1 was observed in three animals from 24 hours to 72 hours after patch. Skin reactions were not observed on Day 4. In both the initial and confirmatory tests, the control sites did not reveal any sign of adverse skin reactions during the observation period.
The individual primary skin irritation index (Individual P.I.I.) of the test substance was ‘0.8’ for all animals. Therefore, the P.I.I. of the test substance was ‘0.8’. The degree of irritation of the test substance was classified as ‘Slightly irritant’ according to the Draize’s method.
However, the test item does not meet the criteria for classification under the Globally Harrmonised Classification System or the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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.
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