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EC number: 923-418-3 | 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
Endpoint summary
Administrative data
Description of key information
The substance is not irritating to the skin in animals and humans. It is slightly irritating to the eye in animals, without classification being required.
For skin and eye irritation the conclusion is “Not classified - based on specific, valid data on the substance”.
Considering these results in high-sensitivity assays, there is no reason to suspect any relevant respiratory irritation, especially as the granulometry of the substance (as the substance is in the form of pearls) leads to negligible exposure of terminal airways.
For this route, the conclusion is “Not classified - based on weight-of-evidence analysis”.
Value used for CSA:
Skin irritation/corrosion: not irritating
Eye irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008/06/03-2008/06/13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No deviation was registred during the study. The experimental protocol was established from the OECD guideline n°404 and was executed in compliance with the Good Laboratory Principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2007/15/02
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals
- Rabbits: New Zealand male albino
- Supplier: elevage de Gérome (Quartier Labaste- F40260 Linxe)
- Acclimatisation period: 5 days
- Weight of animals: between 2.38 and 2.68kg (during the test)
- Age at the beginning of the test: 11 to 12 weeks old
Housing
Each animal was kept in an individual box installed in conventionnal air conditioned animal husbanding; the environmental conditions were:
- T°: between 19 and 23°C
- Relative humidity: between 39 and 52%
- Lighting time: 12 hours daily
- Rate of air exchange: at least ten changes per hour
Drinking water and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: On the opposite flank, an untreated area was served as control.
- Amount / concentration applied:
- 0.5g of the test item was applied on an undamaged skin area of one flank of one animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- If no reaction is observed 72 hours after the treatment, the study was terminated. In case of persistent reactions, additional observations can be carried out from D4 to D14 in order to determine the reversible character of the lesions observed.
- Number of animals:
- Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated during 4 hours.
- Details on study design:
- Approximatively 24 hours before the test, the rabbits' backs anf flancks were shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm².
0.5g of the test item was applied on an undamaged skin area of one flank of one animal. The patch was secured in position with a strip of surgical adhesive tape. After the removal of the patch, the treated area was rinsed with distilled water.
On the opposite flank, an untreated area was served as control.
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated during 4 hours.
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
This examination consists in assessing the irritant reactions in the treated zone, compared to a control area; the following scales are used:
Grading scales :
Erythema and Eschar formation Oedema
0...... No erythema 0 ......No oedema
1...... Very slight erythema (barely perceptible) 1 ......Very slight oedema (barely perceptible)
2......Well defined erythema 2 ...... Slight oedema (contour clearly defined)
3...... Moderate to severe erythema 3 ......Moderate oedema (raised approx. 1mm)
4...... Severe erythema (beef redness) with eschars formation 4 ...... Severe oedema (raised more than 1mm, preventing grading of erythema and extending beyond area of exposure) - Irritation parameter:
- erythema score
- Remarks:
- mean value
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- mean value
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- erythema score
- Remarks:
- mean value
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritant / corrosive response data:
- According to the calculated means, the item must not be classified in accordance with the European regulation 67/548/EEC.
- Other effects:
- It was noted, 1 hour after the test item application, on the treated area, a slight to well defined erythema in the three animals associated with a very slight oedema in one animal. The oedematous reaction was totally reversible at D1 and the erythematous reactions were totally reversible between D1 and D2.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test item is non irritant to skin (Psi=0.3) according to the classification established in the journal officiel de la republique francaise dated February 21st, 1982.
The test item must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with EEC directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the globally harmonized system, the test item must not be classified in category 2 "irritant". No signal word and hazard statement are required. - Executive summary:
The test item lce 08083 was applied, as supplied, at the dose of 0.5 g, under semi occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits. The experimental protocol was established from the OECD guideline n°404 dated April 24th, 2002 and the test method B.4 of the directive n°2004/73/EC
It was noted, 1 hour after the test item application, on the treated area, a slight to well defined erythema in the three animals associated with a very slight oedema in one animal. The oedematous reaction was totally reversible at D1 and the erythematous reactions were totally reversible between D1 and D2.
The test item is non irritant to skin (Psi=0.3) according to the classification established in the journal officiel de la republique francaise dated February 21st, 1982.
The test item must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with EEC directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the globally harmonized system, the test item must not be classified in category 2 "irritant". No signal word and hazard statement are required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008/09/06 to 2008/09/06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No deviation was registred during the study. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n°405 and has been performed in compliance with the Good Laboratory Principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2007
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animal:
- species: new zealand albino rabbits
- Origin: Elevage de Gérome (Quartier Labaste-F40260 Linxe)
- Acclimatation period: 5 days
- Weight: between 2.49 and 3.11 kg (during the test)
- Old: 12 to 13 weeks
Housing:
-T° between 19 and 23°C
- Relative humidity: between 38 and 50%
- Lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
Food and drinking:
- Drinking water and foodstuff were supplied freely
- Microbiological and chemical analyses of the water were carried out once every six months by the Institut Européen de l'Environnement de Bordeaux - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye remained untreated serving as control.
- Amount / concentration applied:
- 0.1g of the test item, reduced in fine powder were introduced into the conjunctival sac of the eye.
- Observation period (in vivo):
- if no reaction is observed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed.
- Number of animals or in vitro replicates:
- Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal at D7, two additional animals were treated.
- Details on study design:
- Occular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- the 3 animals
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72h
- Score:
- ca. 6
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- ca. 0
- Irritant / corrosive response data:
- According to the calculated mean, the test item must not be classified, in accordance with the european regulation.
- Other effects:
- The occular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a slight redness, noted 1 hour after the test item instillation and totally reversible between D3 and D9, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D1 and D3.
- at the corneal level: a moderate opacity, only rehistered 24 hours after the test item instillation in one animal. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is
- slightly irritant for eye (I.O.=11.3) according to the classification established in the journal officiel de la république francaise dated July 10th, 1992.
- and must not be classified according to the criteria for classification, packaging and labelling of dangerous substances in compliance with EEC directive 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the GHS, the test item must not be classified category 2. No signal word and hazard statement are required. - Executive summary:
The test item LCE 08083 was instilled as supplied, at the dose of 0.1g into the eye of three New Zealand rabbits. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n°405 dated April 24th, 2002 and the test method B.5 of the directive 2004/73/EC
The occular reactions observed during the study have been slight to moderate, and totally reversible in the three animals:
- at the conjunctivae level: a slight redness, noted 1 hour after the test item instillation and totally reversible between D3 and D9, associated with a slight to moderate chemosis, noted 1 hour after the test item instillation and totally reversible between D1 and D3.
- at the corneal level: a moderate opacity, only rehistered 24 hours after the test item instillation in one animal.
The test item must not be classified according to the criteria for classification, packaging and labelling of dangerous substances in compliance with EEC directive 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the GHS, the test item must not ba classified category 2. No signal word and hazard sttement are required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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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