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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
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2008-07-16
Test material
- Reference substance name:
- Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts
- EC Number:
- 500-500-3
- EC Name:
- Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts
- Cas Number:
- 161074-67-5
- Molecular formula:
- Not applicable
- IUPAC Name:
- Acylation product between lauroyl chloride and amino acids
- Test material form:
- liquid
- Details on test material:
- • Sponsor’s identification: LCE08088
• Container : plastic flask (n=1)
• Quantity : 1056.60 g (container + contents)
• Batchn° :0801000014
• Production date: 10 January 2008
• CASNo:It was identified under the code number: Pif-08/0226.
• Date reeeived : 22 May 2008
• Form: liquid
• Colour : yellow
• Storage : room temperature
• Retest date: 09 January 2011
• Purity: 28,7% dry extract
Constituent 1
- 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
Test animals
- 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.).
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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).
Applicant's summary and conclusion
- 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.
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