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EC number: 939-042-8 | CAS number: 1482217-03-7
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5th February 2019 - 12th March 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC No 640/2012, Part B: "Skin Sensitization: Local Lymph Node Assay".
- Version / remarks:
- 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- 2003
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate
- EC Number:
- 939-042-8
- Cas Number:
- 1482217-03-7
- Molecular formula:
- C58H56N6O8
- IUPAC Name:
- 1,12-bis({2-[4-(4,6-diphenyl-1,3,5-triazin-2-yl)-3-hydroxyphenoxy]ethyl}) dodecanedioate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): T-1620L
- Analytical purity: 99.9%
- Lot/batch No.:OF1211
- Batch expiry date: 30 April 2014
- Storage condition of test material: RT in the dark
- Other:
Constituent 1
- Specific details on test material used for the study:
- - Physical Description: Pale yellow powder
- Batch (Lot) Number: 10145
- Expiry date: 29 November 2019
- Purity/Composition: 97.3%
- Storage Conditions: At room temperature
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 11 weeks old
- Weight at study initiation: 20.2 to 24.3 g.
- Housing: in polycarbonate cages containing sterilized sawdust as bedding material equipped with water bottles.
- Diet: ad libitum, pelleted rodent diet
- Water: ad libitum, municipal tap-water
- Acclimation period: at least 5 days
- Number of Animals: 20 Females. Five females per group.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): >=10, with 100% fresh air (no air recirculation)
- Photoperiod : A 12-hour light/12-hour
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 or 50% w/w
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: 50% is the highest concentration that could be prepared homogeneously
- Irritation: slight
- Systemic toxicity: none
- Ear thickness measurements: slight increase (7-9%, Day 6)
- Erythema scores: 25%: 1 (Day 2-3)
0 (Day 6);
50%: 1 (Day 2-5)
0 (Day 6);
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: SI ≥ 3,
Irritation
Erythema and eschar formation observations were performed once daily on Days 1-6 (on
Days 1-3 within 1 hour after dosing), according to the following numerical scoring system.
Furthermore, a description of all other (local) effects was recorded.
Erythema and eschar formation:
No erythema ......................................................................................................................................................... 0
Very slight erythema (barely perceptible) ............................................................................................................ 1
Well-defined erythema ......................................................................................................................................... 2
Moderate to severe erythema (beet redness) to slight eschar formation (injuries in depth) .............................. 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema ..................................... 4 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Performed not more than 6 months previously. For both scientific and animal welfare reasons, no concurrent positive control group was included in the study.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 1
- Variability:
- ±0.2
- Test group / Remarks:
- Group 1 (control)
- Parameter:
- SI
- Value:
- ca. 0.8
- Variability:
- ±0.1
- Test group / Remarks:
- Group 2 (10% w/w)
- Parameter:
- SI
- Value:
- ca. 0.6
- Variability:
- ±0.1
- Test group / Remarks:
- Group 3 (25% w/w)
- Parameter:
- SI
- Value:
- ca. 1
- Variability:
- ±0.2
- Test group / Remarks:
- Group 4 (50 %w/w)
Any other information on results incl. tables
Skin Reactions / Irritation
The very slight erythema of the ears as shown by all test item treated animals between Days 1 and 4 was considered not to have a toxicologically significant effect on the activity of the nodes.
Systemic Toxicity
No mortality occurred and no clinical signs of systemic toxicity were observed in the animals. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Macroscopic Examination of the Lymph Nodes and Surrounding Area
The majority of auricular lymph nodes were considered normal in size, except for one node in one animal treated at 50% which was considered to be enlarged. No macroscopic abnormalities of the surrounding area were noted for any of the animals.
Radioactivity Measurements and SI Values
Mean DPM/animal values for the experimental groups treated with test item concentrations 10, 25 and 50% were 992, 835 and 1294 DPM, respectively. The mean DPM/animal value for the vehicle control group was 1297 DPM. The SI values calculated for the test item concentrations 10, 25 and 50% were 0.8, 0.6 and 1.0, respectively.
Table 2 Main Study: Skin Reactions
Group | test item (% w/w) | animal | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | ||||||
Erythema1 | Erythema | Erythema | Erythema | Erythema | Erythema | |||||||||
left | right | left | right | left | right | left | right | left | right | left | right | |||
1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
2 | 10 | 6 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | 0 | 0 |
7 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | 0 | 0 | ||
8 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | 0 | 0 | ||
9 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | 0 | 0 | ||
10 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | 0 | 0 | ||
3 | 25 | 11 | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f |
12 | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | ||
13 | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | ||
14 | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | ||
15 | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0f | 0f | ||
4 | 50 | 16 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0 | 0 | 0 | 0 |
17 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0 | 0 | 0 | 0 | ||
18 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0 | 0 | 0 | 0 | ||
19 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0 | 0 | 0 | 0 | ||
20 | 1f | 1f | 1f | 1f | 1f | 1f | 0f | 0f | 0 | 0 | 0 | 0 |
f. White staining of test item remnants on the dorsal surface of the ears which did not hamper scoring for erythema.
1 Grading erythema and eschar formation (Left = dorsal surface of left ear; right = dorsal surface of right ear):
0 = No erythema
1 = Very slight erythema (barely perceptible)
Table 3
Main Study: Relative Size Lymph Nodes, Radioactivity Counts (DPM) and Stimulation Index (SI)
Group | Test item (% w/w) | Animal | Size nodes1 | DPM2/ animal | mean DPM ± SEM3 | mean SI ± SEM | |
left | right | ||||||
1 | 0 | 1 | n | n | 843 | 1297 ± 299 | 1.0 ± 0.2 |
2 | n | n | 575 | ||||
3 | n | n | 2006 | ||||
4 | n | n | 2001 | ||||
5 | n | n | 1059 | ||||
2 | 10 | 6 | n | n | 591 | 992 ± 116 | 0.8 ± 0.1 |
7 | n | n | 966 | ||||
8 | n | n | 1303 | ||||
9 | n | n | 996 | ||||
10 | n | n | 1103 | ||||
3 | 25 | 11 | n | n | 630 | 835 ± 75 | 0.6 ± 0.1 |
12 | n | n | 952 | ||||
13 | n | n | 681 | ||||
14 | n | n | 918 | ||||
15 | n | n | 995 | ||||
4 | 50 | 16 | n | n | 1148 | 1294 ± 312 | 1.0 ± 0.2 |
17 | n | n | 637 | ||||
18 | n | n | 1143 | ||||
19 | n | + | 2483 | ||||
20 | n | n | 1060 |
1 Relative size auricular lymph nodes (-, -- or ---: degree of reduction, +, ++ or +++: degree of enlargement, n: considered to be normal).
2 DPM = Disintegrations per minute.
3 SEM = Standard Error of the Mean.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no indication that the test item elicits a SI ≥ 3 when tested up to 50%. Based on these results, T-1620L would not be regarded as a skin sensitizer and has no obligatory labelling requirement for sensitization by skin contact according to the GHS and the CLP.
- Executive summary:
Although the results of this study indicate that T-1620L is regarded as a potential skin sensitizer, the response was borderline and there was no evidence of a dose relationship. For these reasons in a later registration to US TSCA a repeat LLNA was requested by the US EPA. The repeat study gave an unequivocal result and is therefore assigned as a key study and used for classification and labelling. Consequently, this study is assigned as supporting information only.
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