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EC number: 928-348-7 | 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
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing – (GHS criteria not met)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test performed in 2008.
LLNA method (OECD 442 B) was adopted in 2010. - Specific details on test material used for the study:
- Test item:
Sponsor's identification: LCE07106
Container: plastic flask (n=1)
Quantity: 184.84 g (container + contents)
Batch n° 0715200018
Production data: 01 June 2007
Date received: 21 December 2007
Form: liquid
Colour: yellow
Storage: Room temperature
Re-test date: 31 May 2009 - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (F-69592 L'Arbresle)
- Age at study initiation: 4 weeks old
- Weight at study initiation: between 232 and 283 g
- Housing: The animals were housed either in groups of 2 or 3 in polycarbonate containers, the flooring of which was covered with dust-free cuttings and the top fitted a stainless steel lid with a feeding device and drinking device of 500 ml.
- Food and drink: The drinking water (tap water from public distribution system) and food were supplied freely. Microbiological verification and chemical analysis were conducted every six months by the Institut Européen de l'Environnement de Bordeaux (I.E.E.B).
- Acclimation period: The animals were kept for a minimum acclimatisation period of 5 days, under stabling and nutritional conditions identical to those of the test.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 19 and 22 °C
- Humidity (%): between 45 and 70 %
- Lighting time:12 hours daily - Route:
- intradermal and epicutaneous
- Concentration / amount:
- Day 0
After shearing the scapular zone, three pair of intradermal injections of 0.1 ml were performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine as follows:
Group 2 (treated):
2 ID: Freund's Complete Adjuvant diluted by 50% in isotonic sodium chloride
2 ID: test item at 0.39%
2 ID: a test mixture with equal volumes v/v
- Freund's Complete Adjuvant at 50% and the test item at 0.78%
Day 6
The scapular zone of all animals in each group was shorn.
Day 7
A topical application under occlusive dressing for 48 hours was performed on the injection sites of each animal.
Group 2 (treated):
0.5 ml of the test item at 100%. After the removal of the patch, the treated areas were rinsed with distilled water. - Day(s)/duration:
- The induction phase lasts 7 days
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 12.5 % (Maximal Non Irritant Concentration) and 6.25 % (1/2 MNIC)
- Day(s)/duration:
- the treatment lasts 24 hours for each concentration
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Negative control group: 5 animals
Treated group: 10 animals - Details on study design:
- INDUCTION PHASE
Day 0
After shearing the scapular zone, three pair of intradermal injections of 0.1 ml were performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine as follows:
Group 1 (negative control):
2 ID: Freund's Complete Adujuvant diluted by 50 % in isotonic sodium chloride
2 ID: isotonic sodium chloride
2 ID: a mixture with equal volumes v/v:
-Freund's Complete Adjuvant at 50 % and isotonic sodium chloride
Group 2 (treated):
2 ID: Freund's Complete Adjuvant diluted by 50% in isotonic sodium chloride
2 ID: test item at 0.39%
2 ID: a test mixture with equal volumes v/v
- Freund's Complete Adjuvant at 50% and the test item at 0.78%
Day 6
The scapular zone of all animals in each group was shorn.
Day 7
A topical application under occlusive dressing for 48 hours was performed on the injection sites of each animal.
Group 1 (negative control):
0.5 ml of distilled water
Group 2 (treated):
0.5 ml of the test item at 100%. After the removal of the patch, the treated areas were rinsed with distilled water.
REST PHASE
The animals of both groups were left for 10 days
CHALLENGE PHASE
Day 20
The experimental procedure of this phase was identical for both groups GROUP 1 (Negative control) and GROUP 2 (treated) submitted to this experimentation: on the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, was performed during 24 hours:
- 1 sample cup containing the test item at 12.5% (MNIC) and at 6.25 % (1/2 MNIC) - Challenge controls:
- The Group 1 (negative control) was submitted to the same experimentation as Group 2 (treated group) during the challenge phase.
- Positive control substance(s):
- yes
- Positive control results:
- Reference substance: alpha-Hexylcinnamaldehyde / CAS n° 101-86-0
Treated animals number: 10
In conclusion, in view of these results, under these experimental conditions, the substance alpha-Hexylcinnamaldehyde;
must be classified R 43 “may cause sensitization by skin contact” in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. This substance must be characterised by the symbol “Xi' and the warming label “Irritant”. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6.25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No visible modification
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In view of these results, under these experimental conditions, the test item LCE07106 must not be classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COMC2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required. - Executive summary:
SUMMARY AND CONCLUSION OF THE STUDY
The aim of the study was to evaluate the possible allergenic activity of the test item LCE07106 after intradermic injection and topical administration in guinea pigs.
After induction (intradermic injection at 0.39% and topical application at 100%) of 10 Guinea Pigs of treated group with the test item LCE07106 and a 10-day rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test item diluted at 12.5% and at 6.25% in distilled water. The experimental protocol was established according the O.E.C.D. guideline n°406 dated July 17", 1992 and the method B6 of the E.E.C. n°96/54 dated July 30th, 1996.
No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test item. No cutaneous intolerance reaction was recorded in animals from the negative control group.
In conclusion, in view of these results, under these experimental conditions, the test item LCE07106 must not classified, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 1. No signal word and hazard statement are required.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
Registered substance (as identified in Section 1.1 identification) has similar chemical structure as the others members of the Category "Amino Acid Alkyl Amides, Sodium or
Potassium Salts" (the source chemicals).
The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” has been developed and evaluated to cover the assessment of the intrinsic properties of several similar
substances within the context of REACH Regulation. The Category includes sodium or potassium salts of amino acid alkyl amides, with a carbon chain length range of C6-C16 and an
aminoacidic pool of not selected aminoacids reflecting the natural distributions of aminoacids in various vegetables and cereals.
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The Category has been built up considering the common chemical structure of its members. They are UVCB substances and they share the following features:
- they are salts of amino acid alkyl amides
- they are sodium or potassium salts
- the carbon chain length ranges between C6 and C16
- the carbon chain derives from cocoyl or lauroyl fatty acids
- the aminoacidic part of the molecules comes from a pool of aminoacids
- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.
Overall, the Category was formed on the hypothesis that substances sharing this common chemical structure can be considered analogues and can share intrinsic properties too. No
trends in properties is expected, except for those physicochemical properties depending on the carbon chain length.
2. CATEGORY APPROACH JUSTIFICATION
These substances share (i) eye damage and (ii) the absence of significant systemic toxicity. - Key result
- Reading:
- other: read-across approach
- Group:
- positive control
- Remarks on result:
- other: Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
- Remarks:
- Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
- Key result
- Reading:
- other: read-across approach
- Group:
- negative control
- Remarks on result:
- other: Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
- Remarks:
- Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
- Key result
- Reading:
- other: read-across approach
- Group:
- test chemical
- Remarks on result:
- other: Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
- Remarks:
- Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A collection of the skin sensitisation data is available for category members.
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not sensitizing – (GHS criteria not met); considering these values the registered substance is not sensitizer.
According to Regulation (EC) n. 1272/2008, the registered substance should not be classified for the skin sensitization data are judged as "conclusive but not sufficient for classification". - Executive summary:
The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” was formed on the hypothesis that substances sharing common chemical structure can be considered analogues and can share intrinsic properties too.
Based on this assumption, this property may be assessed using available data for the category members.
The category has been assessed for members characterized by:
- sodium or potassium salts
- the carbon chain length ranges between C6 and C16
- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- No in vitro test was proposed because this guinea pig test was done in 2004 and no in vitro test existed at that time (OECD tests n°442 C and D adopted in 2015)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No in vitro test was proposed because this guinea pig test was done in 2004 and no in vitro test existed at that time (OECD tests n°442 C and D adopted in 2015)
- Specific details on test material used for the study:
- The product LCE03072, sent by SEPPIC – Avenue Lacaze Basse –F-81105 CASTRES, was received
on 22 December 2003. Its characteristics were :
· Container : plass flask
· Form : liquid
· Quantity : 154.84 g (container + contents)
· Colour : colorless
· Batch : -
· Storage : room temperature
· CAS N° : -
· Purity : -
It was identified under the code number: PH-03/0428. - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 15 male albino guinea pigs of Dunkin-Hartley strain, supplied by Centre de Production animale (F- 45160 Olivet) were exposed to the test product after a 6-day acclimatisation period. For the main study, the animals weighted between 246g and 350g at the beginning of the test.
The environmental parameters were :
- Temperature : between 19°C and 26°C
- Relative humidity : between 30% and 66% - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction phase
1st induction
- 2 intradermal injections of the product diluted at 12.5% in physiological saline solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 25% in physiological
saline solution
2nd induction: topical application, on the same zone, with the product at 100%, 24 hours after brushing with 0.5 mL of a solution of Sodium lauryl
sulfate at 10%.
Challenge phase : topical application under occlusive dressing at the following concentrations : 50% & 25%. - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction phase
1st induction
- 2 intradermal injections of the product diluted at 12.5% in physiological saline solution.
- 2 intradermal injections of Freund’s Complete Adjuvant diluted at 50% in physiological saline solution.
- 2 intradermal injections of a mixture with equal volumes - Freund’s Complete Adjuvant at 50% and the product diluted at 25% in physiological
saline solution
2nd induction: topical application, on the same zone, with the product at 100%, 24 hours after brushing with 0.5 mL of a solution of Sodium lauryl
sulfate at 10%.
Challenge phase : topical application under occlusive dressing at the following concentrations : 50% & 25%. - No. of animals per dose:
- GROUP 1 (negative control) : 5 female guinea pigs identified n° C9296 to C9300;
GROUP 2 (treated) : 10 female guinea pigs identified n° C9311 to C9320. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In view of these results, under these experimental conditions, the product LCE03072, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45, must not be classified.
- Executive summary:
After induction (intradermic injection and topical application) of 10 Guinea Pigs (female) of treated group with the test product LCE03072 and a 18-days rest phase, the challenge phase, under occlusive dressing for 24 hours, consisted to a single topical application of the test product diluted at 50% and at 25% in distilled water, according to the experimental protocol established from the O.E.C.D. guideline n°406 dated July 17th, 1992 and the method B.6 of the E.E.C. n°96/54 dated July 30th,1996.
No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test product.
No cutaneous intolerance reaction was recorded in animals from the negative control group.
In conclusion, in view of these results, under these experimental conditions, the product LCE03072, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45, must not be classified.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
A collection of the skin sensitisation data is available for category members. All found values are listed below.
EC number |
Skin sensitisation |
S1 - EC: 918-984-3 |
not sensitizing - GHS criteria not met |
S2 - EC: 927-837-2 |
not sensitizing - GHS criteria not met |
Overall, registered substance is not sensitizer.
According to Regulation (EC) n. 1272/2008, the substance should not be classified for the skin sensitization data are judged as "conclusive but not sufficient for classification".
According to Regulation (EC) n. 1272/2008, the substance should not be classified for the respiratory sensitization because of data lacking.
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