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EC number: - | 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 May 2019 - 28 May 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Batch TROD7BB06
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Remarks:
- CBA/JRj
- Sex:
- female
- Details on test animals and environmental conditions:
- Female CBA/J (CBA/JRj) strain mice (SPF caw) were supplied by Elevage Janvier Labs (F-53941 Le Genest Saint Isle). On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant.
After an acclimatisation period of at least five days under stabling and nutritional conditions identical to those of the test, the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
At the start of the main study the animals were 8 weeks old.
The animals were weighed at the beginning and at the end of the study (see table 3).
Housing
The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
The temperature and relative humidity were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively.
The rate of air exchange was at least ten changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Food and drink
The drinking water (tap water from public distribution system) and food (ENVIGO 2016) were supplied ad libitum.
Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas – Eurofins (FRANCE).
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 50%, 25% and 10%. 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear
- No. of animals per dose:
- 4
- Details on study design:
- Groups of four mice were treated with the test item undiluted diluted at 50%, 25% and 10% in N,N-dimethylformamide (DMF). The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- An EC1.6 value of 14.41% was observed for the test item α-Hexylcinnamaldehyde, resulting in a classification as category 1 “Skin sensitisation” in accordance with the Regulation (EC) No. 1272/2008.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.01
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.05
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.36
- Test group / Remarks:
- 50%
Any other information on results incl. tables
Clinical observations and mortality
No mortality and no signs of systemic toxicity were noted in the test and control animals during the
test.
Weight evolution
No statistical significant change in body weight was noted for all treated groups versus control group
(Student’s test).
Estimation of the proliferative response of lymph node cells
No stimulation index higher than 1.6 was recorded whatever the tested concentrations.
The Stimulation Index (SI) calculated by individual approach was 1.01, 1.05 and 1.36 for the treated groups at 10%, 25% and 50%, respectively.
Therefore, the EC1.6 cannot be determined due to the absence of SI value higher than 1.6.
Local irritation
Residual test item was noted in all animals treated at 50% between Days 2 and 6.
Red coloration not preventing quotation of erythema was noted in animals treated at 10% between Days 3 and 5 and in animals treated at 25% between Days 3 and 6.
No increase in ear thickness and in ear weight was noted in animals treated at 10%, 25% and 50%, respectively.
Therefore, the test item has to be considered as not excessively irritant at these concentrations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item Acetic acid, oxo-, sodium salt, reaction products with ethanolamine and phenol, sodium hydroxide and ferric chloride (MEAHA Fe) does not have to be classified as a skin sensitizer, in accordance with the Regulation EC No. No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required. - Executive summary:
The test was performed to assess the skin sensitisation potential of the test item Acetic acid, oxo-, sodium salt, reaction products with ethanolamine and phenol, sodium hydroxide and ferric chloride (MEAHA Fe) in the CBA/J strain mouse following topical applications to the dorsal surface of the ear. The basic principle underlying the LLNA:BrdU is that sensitizers induce proliferation of lymphocytes in the lymph nodes draining the site of test item application.
Three groups of four animals were treated for three consecutive days (D1, D2, D3) with 50 μL (25 μL per ear) of the test item diluted at concentrations of 10%, 25% and 50% in N,N-dimethylformamide (DMF)
A further group of four animals was treated with DMF.
On D5, 0.5 mL of BrdU solution (10 mg/mL) was injected by the intraperitoneal route.
On D6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by measurement of BrdU content in DNA of lymphocyte using an ELISA kit.
The experimental protocol was established according to the O.E.C.D. Guideline No. 442-B adopted 25 June 2018.
No mortality and no signs of systemic toxicity were noted in the test and control animals during the test.
Residual test item was noted in all animals treated at 50% between Days 2 and 6.
Red coloration not preventing quotation of erythema was noted in animals treated at 10% between Days 3 and 5 and in animals treated at 25% between Days 3 and 6.
No increase in ear thickness and in ear weight was noted in animals treated at 10%, 25% and 50%, respectively.
Therefore, the test item has to be considered as not excessively irritant at these concentrations.
The Stimulation Index (SI) calculated by individual approach was 1.01, 1.05 and 1.36 for the treated
groups at 10%, 25% and 50%, respectively.
Therefore, the EC1.6 cannot be determined due to the absence of SI value higher than 1.6.
The results obtained, under these experimental conditions, enable to conclude that the test item Acetic acid, oxo-, sodium salt, reaction products with ethanolamine and phenol, sodium hydroxide and ferric chloride (MEAHA Fe) does not have to be classified as a skin sensitizer, in accordance with the Regulation EC No. No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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