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EC number: 466-080-8 | 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 August 2006 to 15 September 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 96/54
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- EPA 712-C-03-197
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of testing (2006) the OECD 406 was still an accepted OECD test method.
Test material
- Reference substance name:
- -
- EC Number:
- 466-080-8
- EC Name:
- -
- Molecular formula:
- C23H31N3O4
- IUPAC Name:
- 466-080-8
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Name: LFC 2098
Product/common name: LFC 2098
Purpose: Industrial chemical
Colour: white
Physical state: solid, powder
Purity: 99. 69%
Storage: at room temperature, protected from light
Molecular formula: C23H31O4N3
Molecular weight: 413
Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- 10/5 (test/control) Hsd Poc : DH — guinea pigs (Full-Barrier) , Sex: female, nulliparous, nonpregnant, body weight at the commencement of the study 300 — 500 g.
5 (range finding) Hsd Poe : DH — guinea pigs (Full-Barrier) , Sex: female, nulliparous, nonpregnant, body weight at the commencement of the study 300 - 500 g.
A health inspection was performed to ensure the good state of health of theanimals:
The animals were derived from a controlled full barrier maintained breeding system (SPF).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Animal Husbandry
The animals were barrier maintained (semi—barrier) in an air conditioned room
— Temperature: 22 ± 3 °C
— Rel. humidity: 55 ± 10%
— Artificial light, sequence being 12 hours light, 12 hours dark
— Air change: at least 10 x / hour
— Feeding ad libitum, ssniff Ms-H, 4mm V2233-000 complete diet for guinea pigs, rich in crude fiber, totally pathogen-free (TPF)
— Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
— The animals were kept in groups in Terluran - cages on Lignocel bedding
— Certificates of food, water and bedding are filed at BSL Bioservice
— Adequate acclimatization period
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 1:1 FCA/Saline
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- Day 1 / single injection
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 2.5% / 0.1 ml
- Day(s)/duration:
- Day 1 / single injection
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- other: 1:1 FCA/Saline
- Concentration / amount:
- 2.5% test material / 0.1ml
- Day(s)/duration:
- Day 1 / single injection
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.5g test material
- Day(s)/duration:
- Day 7 / 48 hours
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 7 / 48 hours
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5g test material
- Day(s)/duration:
- Day 20 / 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- cotton seed oil
- Concentration / amount:
- 0.5 ml
- Day(s)/duration:
- Day 20 / 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 test
5 control
5 range-finder - Details on study design:
- Induction: First Stage, Intruder-moi Injection
Three pairs of intraderrnal injections of 0.1 mL volume were given in the shoulder region which was cleared of hair by clipping so that one of each pair lies on each side of the rnidline.
Test group: Day 0
- Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
- Injection 2: a 2.5% concentration of the test substance in Cotton Seed Oil
- lnj ection 3: a 2.5% concentration of the test substance formulated in a 1:1 mixture (v/v) FCA/physiological saline
Control group: Day 0
- Injection 1: a 1:1 mixture (v/v) FCA/physiological saline
- Injection 2: Cotton Seed Oil at a concentration of 100%
- Injection 3: a 50% (v/v) formulation of Cotton Seed Oil in a 1:1 (v/v) mixture FCA/physiological saline
- Injections l and 2 were given close to each other and nearest to the head, while 3 is given toward the caudal part of the test area.
Induction: Second Stage, Topical Application
- Test and Control Group: Day 6
Approximately twenty-four hours before the topical induction application the test area was close-clipped.
- Test Group: Day 7
A patch was fully loaded with 0.5 g of the prepared test item, applied to the test area and held in contact by an occlusive dressing for 48 hours.
- Control Group: Day 7
A patch was fully loaded with 0.5 mL of Cotton Seed Oil and applied to the test area and held in contact by an occlusive dressing for 48 hours.
Challenge: Topical Application
The flanks of treated and control animals were cleared of hair by close-clipping.
- Test and Control Group : Day 20
A patch loaded with 0.5 g of the prepared test item was applied to the left flank of the animals and, a patch loaded with 0.5 mL Cotton Seed Oil to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours.
Observation
Test and Control Group
Approximately 21 hours after removing the patch the challenge area was cleaned with tap water and cleared of hair by the use of a depilation creme.
Approximately 24 hours after removing the patch the skin reaction was observed and recorded according to the grades shown below. Two more observations were recorded 48 and 72 hours after patch removal.
Additionally all animals have been observed for signs of toxicity at least once daily during the test period.
Evaluation of Results
The percentage of animals sensitized in comparison to the negative control group and to the intraspecific control was calculated for each time of observation. The highest percentage was used for the rating of the test item.
Individual data were recorded in tabular form.
The body weights of the test- and control group were determined at the commencement and at the end of the study.
Reliability Check
The recent reliability check was performed in July/August 2006. The raw data of this study are kept in the ESL archives (B SL Project ID 062189). The reliability checks were audited by the QA-unit periodically.
Positive control substance: Mercaptobenzothiazole, Purity > 98%, CAS No. 149-30-4, Lot 835857 306, Merck
Concentrations:
- 2% induction 1 phase
- 25% induction ll phase
- 15% challenge
The sensitization rate after application of the positive control substance Mercaptobenzothiazole (15% in Vaseline) was 90 %, confirming the reliability of the test system. - Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole; 15% in Vaseline
Results and discussion
- Positive control results:
- See Table 2 below.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5g test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5g test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5g test material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5g test material
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5g test material
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5g test material
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- Mercaptobenzothiazole; 15% in Vaseline
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- Mercaptobenzothiazole; 15% in Vaseline
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- Mercaptobenzothiazole; 15% in Vaseline
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 2. Frequency of Sensitization in Positive Control Animals
10 animals used for positive control group
E0 | E1 | E2 | E3 | E4 | O0 | O1 | O2 | O3 | O4 | % animals diseased | |
P24 | 1 | 7 | 2 | 0 | 0 | 10 | - | - | - | - | 90 |
P48 | 3 | 7 | 0 | 0 | 0 | 10 | - | - | - | - | 70 |
P72 | 9 | 1 | 0 | 0 | 0 | 10 | - | - | - | - | 10 |
E = Erytherna
O = Oedema
0-4 = Grade
P: Positive Control group (Mercaptobenzothiazole; 15% in Vaseline)
24, 48, 72 hours after end of challenge treatment;
Table 3. Grade of Reactions in Preliminary
Test Skin Reactions after Inrtrademial Injection
Animal No. | Conc. % (left/right) | 24 hours | 48 hours | 72 hours | |||
Erythema | Oedema | Erythema | Oedema | Erythema | Oedema | ||
1 | 2.5 | 1 | 0 | 0 | 0 | 1 | 0 |
2.5 | 1 | 0 | 0 | 0 | 1 | 0 |
Skin Reactions after Topical Application
Animal No. | Conc. % (left/right) | 24 hours | 48 hours | 72 hours | |||
Erythema | Oedema | Erythema | Oedema | Erythema | Oedema | ||
10 (24 hour exposure) | 100 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 0 | 0 | 0 | 0 | 0 | 0 | |
12 (48 hour exposure) | 100 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 0 | 0 | 0 | 0 | 0 | 0 | |
11 (24 hour exposure) | 100 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 0 | 0 | 0 | 0 | 0 | 0 | |
13 (48 hour exposure) | 100 | 0 | 0 | 0 | 0 | 0 | 0 |
50 | 0 | 0 | 0 | 0 | 0 | 0 |
Main Test
Induction readings:
1. Induction i: After 24 hours, at injection site 2 erythema grade 1 in 6 of 10, at injection site 3 erytherna grade l in 4 of 10 animals. After 48 hours, at injection site 2 erytherna grade 1 in 8 of 10, at injection site 3 erytherna grade 1 in 6 of 10 animal . No other signs of irritations were observed in any of the animals (Induction first stage).
2. No signs of irritation were observed in any of the animals after the topical application (Induction second stage).
Challenge readings:
The results of the experimental animals at the challenge phase were compared with the results of the control animals.
No signs of irritation were observed after the challenge.
The maximum percentage of animals sensitized was 0%.
For single data. see tables 4a and 4b.
Animals of both groups survived throughout the test period. Animals of the test group showed no reduced weight gain compared to historical data (table 5).
Table 4a. Frequency of Sensitization in Comparison to Control Animals Summary
E0 | E1 | E2 | E3 | E4 | O0 | O1 | O2 | O3 | O4 | % animals diseased | |
T24 | 10 | - | - | - | - | 10 | - | - | - | - | 0 |
T48 | 10 | - | - | - | - | 10 | - | - | - | - | 0 |
T72 | 10 | - | - | - | - | 10 | - | - | - | - | 0 |
C24 | 5 | - | - | - | - | 5 | - | - | - | - | |
C48 | 5 | - | - | - | - | 5 | - | - | - | - | |
C72 | 5 | - | - | - | - | 5 | - | - | - | - |
E = Erythema
O = Oedema
0-4 = Grade
T = Test group
C = Control group
24, 48, 72 hours after end of challenge treatment
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not found to be a skin-sensitiser under the conditions of the test.
- Executive summary:
On the basis of the test results given below and in conformity with the criteria given in Annex VI of the Directive, the substance should be not classified.
Species/strain: Hsd Poc : DH — guinea pigs (Full-Barrier)
Number of animals in test group: 10
Number of animals in negative control group: 5
Maximum concentration not giving rise to irritating effects in the preliminary test: 100%
Concentrations of test material and vehicle used at each stage of induction:
- First induction: 2.5% of the test itern, diluted in Cotton Seed Oil
- Second induction: 100% of the test item, moistened with Cotton Seed Oil
Concentrations of test material and vehicle used at each stage of challenge:
- 100% of the test itein, moistened with Cotton Seed Oil
Signs of irritation during the induction:
Induction 1: After 24 hours, at injection site 2 erythema grade 1 in 6 of 10, at injection site 3 erythema grade 1 in 4 of 10 animals. After 48 hours, at injection site 2 erythema. grade 1 in 8 of 10, at injection site 3 erythema grade 1 in 6 of 10 animal . No other signs of irritations were observed in any of the animals.
Induction 2: No signs of irritations were observed in any of the animals.
Number of animals showing skin reactions after Challenge concentrations of test substance (%) 1st challenge 2nd challenge 1st ch. 2nd ch. 24 h 48 h 72 h 24 h 48 h 72 h Test group 10 - 0 0 0 - - - Negative control group 10 - 0 0 0 - - - Evidence of sensitization at each challenge: No treatment related effects were observed.
Other observations: No treatment related effects were observed.
Method (type of test): OECD 406 & 96/54/EC B.6
Considering the reported data of this sensitization test it can be stated that the test item LFC 2098 at the tested concentration caused no reactions identified as sensitization.
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