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EC number: 500-500-3 | CAS number: 161074-67-5
- 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
Test material: the liquid marketed product "Proteol OAT" which contains ca.27.5% of the solid substance "Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts".
Two GLP studies following OECD guidelines 404 and 405 were performed.
The registered substance is not irritating to the skin but is irritating to eyes
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-06-03 to 2008-06-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline, GLP study
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2008-07-16
- Specific details on test material used for the study:
- Sponsor's identification: LCE08088
Container: plastic flask
Quantity: 1056,60 g
Batch: 0801000014
Form: liquid
Colour: yellow
Storage: room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three male albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste — F40260 Liuxe). They were kept during a minimal 5-day aclimatisation period. During the test, the animals weighed between 2.33 kg and 3.08 kg. At the beginning of the test, the animais were 11 to 12 weeks old.
Housing
Bach animal was kept in an individual box installed in conventional air conditioned animal husbanding; the environmentai conditions were:
- temperature : between 19°C and 23°C
- relative huniidity : between 39% and 52%
- lighting time: 12 hours daiiy
- rate of air exchange : at least ten changes per hour
Food and drink
Drinking water (tap-water from public distribution system) and foodstuff (SDS — C15) were supplied
freely.
Microbiologieal and chemical analyses of the water were carried ont once every six months by the
Institut Européen de l’Environnement de Bordeaux (1.E.E.B.). - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Other side
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- Treatment
Approximately 24 hours before the test, the rabbits’ backs and flanks were shorn using electric clippers equipped with a fine comb, so as to expose an area of skin about 6 cm2.
As no tissue destruction vas noted afler a treatment during 3 minutes and during 1 hour, the test item was applied, as supplied, al a dose of 0.5 mL, on an undamaged skin area of one flank of one animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape. Afler the removal of the patch, the treated area ;vas rinsed with distilled water.
On the opposite flank an untreated area vas served as the control.
Initially, a single animal was treated. After consideration of the cutaneous responses produeed in the first treated animal, two additional animais were treated during 4 hours. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.5
- Max. score:
- 2
- Irritant / corrosive response data:
- It was noted, 24 hours after the test item application, on the treated area, a well defined erythema associated with a slight oedema. The oedematous reactions were totally reversible between D2 and D6 and the erythematous reactions were totaly reversible between D3 and D6.
On the cutaneous structure, a slight dryness vas noted on the treated area, between D3 and D8 in two animais. In the last animal, a dryness vas registered between D3 and D14 (end of tire observation time). - Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item LCEO8O88, according to the scales of interpretation retained:
- is irritant to skin (PSi 3.2) according to the classification established in the Journal Officiel de la République Française dated February 2], 1982,
- and, must be classifiEd R38 “irritating to skin”, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2 001/59 and 99/45. The item must ho cliaracterised by the symbol “Xi” and the warning label “irritant”.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 2 “irritant”. No signal word and hazard statement are required. - Executive summary:
The test item LCEO8O88 was applied, as supplied, at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C.D. guideline n° 404 dated April 24th, 2002 and the test method B.4 cf the directive n° 2004/73/EC’.
It was noted, 24 hours afler the test item application, on the treated area, a well defined erythema associated with a slight oedema, The oedematous reactions were totally reversible between D2 and D6 and the erythematous reactions were totally reversible between D3 and D6. On the cutaneous structure, a slight dryness vas noted on the treated area, between D3 and D8 in two animals, In the last animal, a dryness was registered between D3 and D14 (end of the observation time).
The results obtained, in these experimental conditions, enable to conclude that the test item LCEO8O88 must be classffied R38 “irritating to skin”, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2 001/59 and 99/45. The item must be characterised by the symbol “Xi” and the warning label “irritant”. In accordance with the Globally Harmonized System (COM(2007)355 fmal), the test item must not be classified in category 2 “irritant”. No signal word and hazard statement are required.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- This Draize test (OECD 405) was performed in 2008, at that time no in vitro test evaluating the eye irritation potential was set up (OECD tests n° 437 and 438 adopted in 2009, OECD tests n°491 and 492 adopted in 2015) and no "top-down/bottom-up" approach existed.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-06-09 to 2008-07-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline, GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Test item
Sponsor's identification: LCE08088
Container: plastic flask (n=1)
Quantity: 1056,60 g (container + contents)
Batch: 0801000014
Form: liquid
Colour: yellow
Storage: room temperature - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste-. F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the animais weighed between 3.04 kg and 3.71 kg. At the beginning ofthe test, the animals were 13 weeks old.
Housing
The animals were kept in an individual box installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 19°C and 24°C
- relative humidity : between 38% and 64%
- lighting time: 12 hours daily
- rate of air exchange: at least ten changes per hour
Food and drink
Drinking water (tap-water from public distribution system) and foodstuff (SDS - C 15) were supplied freely, Microbiologicai and chemical analyses of the water were carried out once every six months by the Institut Européen de l’Environnement de Bordeaux (I.E.E.B.). - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Until natural elimination
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is termined. In case of persistent reactions, additional observations can be carried out from D4 to D21 in order to determine the reversibility character of the lesions observed. - Number of animals or in vitro replicates:
- 3
- Details on study design:
- 0.1 mL of the test item vas instilled, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
lnitially, a single animal vas treated. Alter consideration of the ocular responses produced in the fïrst treated animal at D14, two additionai animals
were treated. - Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been moderate, and totally reversible in the three animals:
- at the conjuctivae level: a moderate redness, noted 1 hour after the test item instillation and totally reversible between D8 and D9.
- at the corneal level: a moderate opacity, registered 24 hours alter the test hem instillation and totally reversible between D9 and D 17,
- at the iris level: a congestion noted 1 hour and 24 hours alter the test item instillation in two animals and between 1 hour alter the test hem instillation and D6 in the Iast animal. - Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item LCE08088:
- is highly irritant for the eye (Max. 0.1 = 54.3) according to the classification established in the Journal Officiel de la République Française dated July 10th, 1992.
- and, must be classified R36 “irritating to eyes” according to the criteria for the classification, packaging and labelling of dangerous substances in
compliance with the E.E.C. Directive n° 67/548, 200 1/59 and 99/45. The test item must be characterised by the symbol “Xi” and the warning label
“irritant “.
In accordance with the Globally Harmonized System (COM(2007)3 55 final), the test item must be classified in category 2 “irritating to eyes”. The
signal word and hazard statement H319 “Causes serious eye irritation” are required. - Executive summary:
The test item LCE08088 was instilled as supplied, at the dose of 0.1 mL into the eye of three New Zealand rabbits, The experimental protocol was established on the basis of the official method as defined in the O.E. C.D. guideline n° 405 dated April 24°, 2002 and the test method B. 5 of the directive 2004/73/EC.
The ocular reactions observed during the study have been moderate, and totally reversible in the three animals: - at the conjunctivae level: a moderate redness, noted 1 hour afler the test item instillation and totally reversible between D9 and D11, associated with a moderate chemosis, noted 1 hour afler the test item instillation and totally reversible between D8 aud D9; - at the corneal level: a moderate opacity, registered 24 hours afler the test hem instillation and totally reversible between D9 and Dl7, - at the Iris level: a congestion noted 1 hour and 24 hours afler the test hem instillation in two animals and between 1 hour afler the test item instillation and D6 in the last animal.
In conclusion, the result obtained, under these experimental conditions, enables to conclude that the test item LCE08088 must be classified R36 “irritating to eyes” according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/5 9 and 99/45. The item must be characterised by the symbol “Xi” and the warning label “irritant”. In accordance with the Globally Harmonized System (COM(2007)355 fmal), the test item must be classifïed in category 2 “irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must be classified in category 1 “severely irritating to eyes, H318.
Indeed, eye irritation classification is based on a worst case assumption for the effects of 100% neat substance, based on the study results obtained on 27.5 % substance solutions. The registered substance is an organic marketed or used in aqueous formulation, clear liquid form and yellow tint color at 20°C and 101.3kPa.
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.