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EC number: 807-349-5 | CAS number: 1198395-24-2
- 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
OECD 429: negative
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-07-18 to 2017-01-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 july 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- updated 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc, Postbus 6174, NL - 5960, AD Horst
- Age at study initiation: 1st pre-test: 10-11 weeks, main study: 8 - 9 weeks
- Weight at study initiation: 1st pre-test: 20.3 & 20.7 g, main study: 17.3 - 21.7 g
- Housing: grouped per dose
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 – 65 %
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: day 1 To: day 5 - Vehicle:
- methyl ethyl ketone
- Concentration:
- 1st pre-test: 10 and 25 %
main study: 5, 10, and 25 (w/w) - No. of animals per dose:
- pre-test: 2
main study: 4 ( 3 treatment groups and on vehicle control group, total 16) - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The highest test item concentration, which can be technically used was a 25% solution in DMF.
- Irritation / Systemic toxicity: From day 2 to 6, the animals showed an erythema of the ear skin (score 1, see Appendix 1 for details). No signs of excessive local skin irritation were present in both animals.
Thus, the test item in the main study was assayed at 5, 10, and 25%. The highest concentration tested was the highest level that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed in the pre-experiment.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: Stimulation index > 3
TREATMENT PREPARATION AND ADMINISTRATION:
Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 5, 10 and 25 in DMF. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (diameter approx. 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals).
Five days after the first topical application (day 6) 250 μL of phosphate-buffered saline containing 3H-methyl thymidine were injected into each test and control mouse via the tail vein.
Approximately five hours after treatment with 3HTdR, all mice were euthanized by using CO2, draining lymph nodes were rapidly excised and pooled for each experimental group (8 nodes per group) and single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- All calculations conducted on the DPM values were performed with a validated test script of “R”, a language and environment for statistical computing and graphics.
- Positive control results:
- Conc. SI
10% 5.51
25% 7.14
50% 7.31 - Key result
- Parameter:
- SI
- Value:
- 1.26
- Test group / Remarks:
- Test Group: 5 %
- Key result
- Parameter:
- SI
- Value:
- 1.09
- Test group / Remarks:
- Test Group: 10 %
- Key result
- Parameter:
- SI
- Value:
- 0.96
- Test group / Remarks:
- Test Group: 25 %
- Cellular proliferation data / Observations:
- Calculation of the EC3 value
The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
Viability / Mortality
No deaths occurred during the study period.
Clinical Signs
No signs of systemic toxicity were observed during the study period. On day 2 and 3 the animals showed an erythema of the ear skin
Body Weights
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age. - Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item was not a skin sensitiser under the test conditions of this study.
- Executive summary:
The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 429. The test item was not a skin sensitiser under the test conditions of this study.
Reference
Calculation and Results of Individual Data
Test item concentration / [%] |
Group |
DPM |
Calculation |
Result |
||
DPM BG (a) |
No of LN |
DPM / LN (b) |
S.I. |
|||
- |
BG I |
16 |
- |
- |
- |
- |
- |
BG II |
17 |
- |
- |
- |
- |
0 |
1 |
5467 |
5450.5 |
8 |
681.3 |
1.00 |
5 |
2 |
6884 |
6867.5 |
8 |
858.4 |
1.26 |
10 |
3 |
5943 |
5926.5 |
8 |
740.8 |
1.09 |
25 |
4 |
5257 |
5240.5 |
8 |
655.1 |
0.96 |
1 = Control Group
2-4 = Test Groups
BG - Background
DPM - disintegrations per minute
LN - Lymph Node
S.I. - Stimalation Index
(a) = The mean value was taken from the figures BG I and BG II
(b) = Since the lymph nodes of the animals of a dose group were pooled,
DPM/node was determined by dividing the measured value by the number of
lymph nodes pooled
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
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
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.
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