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EC number: 628-079-2 | CAS number: 3680-69-1
- 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 LLNA study was performed on the test item according to OECD Guideline 442B under GLP.
Topical application of test article at 10%, 25%, and 50% (w/v) in DMSO resulted in SI values greater than 1.6. Therefore, this test article is a dermal sensitizer in the Local Lymph Node Assay.
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:
- From 20 Dec 2016 to 19 Jan 2017
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Jackson Laboratories (Bar Harbor, ME) on 07 Dec 2016.
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: The animals were born on 18 Oct 2016, ± 3 days.
- Weight at study initiation: The Day 1 body weight range for the preliminary dermal irritation screen animals was 18.7 - 20.8 grams. The Day 1 body weight range for the main test animals was 20.6 - 24.5 grams.
- Housing: During the acclimation period the animals were housed two per cage in suspended wire-bottom cages; during the study the animals were housed one per cage. Bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rodent Chow (Diet No. 5001) were available ad libitum.
- Water (e.g. ad libitum): Water were available ad libitum.
- Acclimation period: at least five days
- Indication of any skin lesions: The animals were observed prior to the study start to ensure that
no skin lesions were present on the ears.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature-controlled
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 10%, 25% and 50% [w/v]
- No. of animals per dose:
- 5 females
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The test article was found to be soluble in DMSO, with approximately 30 minutes of sonication.
- Irritation: no
- Systemic toxicity: no
- Ear thickness measurements: Ear thickness measurements were performed on Day 1 prior to dosing, on Day 3 before the third test article application, and on Day 6 before euthanasia. None of the test article treatments resulted in increases in ear thickness of 25% or more, and therefore the test article was not considered irritating.
- Erythema scores: No test article treatment produced erythema.
MAIN STUDY
The test article concentrations used in the main LLNA study were chosen such that the
maximum concentration tested was the highest achievable solution of the test article in the vehicle, while avoiding both overt systemic toxicity and excessive local dermal irritation. Concentrations of 10%, 25% and 50% (w/v) were chosen.
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A test article is considered to have a positive response if treatment results in a 1.6-fold or greater increase in the mean LNC proliferation (BrdU ELISA OD values) relative to that obtained for the vehicle control. Therefore, test articles that yield an SI value of 1.6 or more are characterized as potential sensitizing articles.
TREATMENT PREPARATION AND ADMINISTRATION: Treatment was made by topical application of the test article concentrations to the dorsum of each ear once daily for three consecutive days. The test article was spread over the entire dorsal surface of the ear using a micropipette to deliver 25 μl/ear. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical evaluation of the calculated SI values was made by ANOVA followed by the Student's t-test.
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10% w/v
- Key result
- Parameter:
- SI
- Value:
- 1.9
- Test group / Remarks:
- 25% w/v
- Key result
- Parameter:
- SI
- Value:
- 3.3
- Test group / Remarks:
- 50% w/v
- Cellular proliferation data / Observations:
- Mortality and Systemic Observations:
All animals survived the in-life phase of the study.
Body Weights:
Body weight changes were normal.
Erythema Scores:
No test article treatment produced erythema. The 25% HCA positive control produced no more than very slight erythema.
Ear Thickness as a Measure of Dermal Irritation:
In the main test, none of the test item concentrations tested resulted in excessive dermal irritation. - Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Topical application of test article at 10%, 25%, and 50% (w/v) in DMSO resulted in SI values greater than 1.6. Therefore, this test article is a dermal sensitizer in the Local Lymph Node Assay.
- Executive summary:
The LLNA study was performed on the test item according to OECD Guideline 442B under GLP.
Topical application of test article at 10%, 25%, and 50% (w/v) in DMSO resulted in SI values greater than 1.6. Therefore, this test article is a dermal sensitizer in the Local Lymph Node Assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
LLNA study give positive result with SI value of greater than 1.6.
According to Regulation (EC) No 1272/2008, table 3.4.2, this substance should be classified as Category 1B for this endpoint.
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