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EC number: 221-698-5 | CAS number: 3195-78-6
- 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
The test substance is considered to be not sensitising.
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:
- 2015-03-05 to 2015-03-31
- 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:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Cytotest Cell Research GmbH, 64380 Rossdorf, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Batch: 68005536W0
Expiry Date: 01 July 2015
Storage Conditions: In the refrigerator between 2 and 8°C, avoid temperatures > 10°C - Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., 5960 AD Horst / The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Pre-test: 10 - 11 weeks (beginning of treatment); Main study: 8 - 9 weeks (beginning of treatment)
- Weight at study initiation: 17.9-21.2 g
- Housing: group, Makrolon Type II (pre-test) / III (main study), with wire mesh top
- Diet: ad libitum, 2018C Teklad Global 18 % protein rodent diet (certified)
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
- Indication of any skin lesions: Only animals without any visible signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45-65
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- propylene glycol
- Concentration:
- 25, 50 and 100 %
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The highest test item concentration, which could be technically used was 100% of the undiluted test item. Test item solutions at different concentrations were prepared using PG as vehicle.
- Irritation: After treatment with 50 and 100 % test substance for 3 days animals did not show any signs of local skin irritation.
- Systemic toxicity: Not detected.
- Ear thickness measurements: No increase in ear thickness of ≥ 25 % was recorded.
- Erythema scores: No erythema was detected.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
The animals were distributed into the test groups at random.
- Criteria used to consider a positive response: The cut-off values for a positive response were stimulation index of 3, for the lymph node cell count index of 1.55 and for the ear weight index of 1.1.
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 25 and 50 % in PG, and 100 %. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (∅ ∼ 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 vehicle alone (control animals). For positive control a periodic positive control experiment was used. Five days after the first topical application (day 6) 250 μL of phosphate-buffered saline containing 20.2 μCi of 3H-methyl thymidine (equivalent to 80.9 μCi/mL 3HTdR) were injected into each test and control mouse via the tail vein. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables, for the ear weights, the lymph node weights and lymph node cell count, and for the DPM values (group mean DPM ± standard deviation). A statistical analysis was conducted on the DPM values, the ear weights, the lymph node weights and the lymph node cell count to assess whether the difference was statistically significant between the test item groups and negative control group. For all statistical calculations custom made statistical program ´R` Decision Tree was used. Statistical significance was set at the five per cent level (p < 0.05). The Dean-Dixon-Test and the Grubb’s test were used for detection of possible outliers (performed with custom made statistical program ´R` Decision Tree).
- Key result
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 25 % treatment group
- Key result
- Parameter:
- SI
- Value:
- 1.04
- Test group / Remarks:
- 50 % treatment group
- Key result
- Parameter:
- SI
- Value:
- 0.57
- Test group / Remarks:
- 100 % treatment group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
For the 25 % test substance group the mean DPM count was 1296.3 (±567.1). For the 50 % test substance group the mean DPM count was 1184.7 (±534.2). For the 100 % test substance group the mean DPM count was 646.3 (±253.9).
DETAILS ON STIMULATION INDEX CALCULATION
The ratio of 3HTdR incorporated into lymph node cells of test animals relative to that recorded for lymph nodes of control animals was calculated.
EC3 CALCULATION
The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
CLINICAL OBSERVATIONS:
No signs of systemic toxicity or local skin irritation were observed.
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. The animals treated with the undiluted test item lost 6.3 % of their average body weight. - Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test item was assessed for its skin sensitising potential using the Local Lymph Node Assay (LLNA, OECD 429) in mice. Test item solutions at concentrations of 25, 50 and 100 % were prepared in the vehicle propylene glycol (PG). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation (as determined by a pre-experiment). The animals showed neither signs of systemic toxicity nor local skin irritation during the course of the study and no cases of mortality were observed. A loss of body weight of about 6.4 % was observed in the high dose group, but as the affected animals were free of any symptoms, this loss of body weight was considered to be unspecific. A statistically significant decrease in ear weights was observed in the high dose group in comparison to the vehicle control group (p<0.05). However, this was not biologically relevant. Furthermore, for BALB/c mice, a cut-off value of 1.1 for the ear weight index was reported for a positive response regarding ear skin irritation. None of the indices determined for the test item treated groups reached or exceeded this threshold. Stimulation Indices (S.I.) of 1.13, 1.04, and 0.57 were determined with the test item at concentrations of 25 and 50 % in PG, and 100 % (undiluted), respectively. An unusual dose response was observed. A statistically significant or biologically relevant increase in DPM value and also in lymph node weight and -cell count was not observed in any treated group in comparison to the vehicle control group. Furthermore, the cut-off value of 1.55 for a positive response regarding the lymph node cell count index reported for BALB/c mice was not reached or exceeded in any dose group. Based on the results of the study the test item was thus not a skin sensitiser under the test conditions of this study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available data are reliable and suitable for classification purposes under Regulation 1272/2008. No skin sensitising potential was identified. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
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