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Diss Factsheets
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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From May 17 th to 30 th, 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The source study has a reliability of 1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Similar Substance1
- IUPAC Name:
- Similar Substance1
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Horst, The Netherlands.
- Age at study initiation: Young adult animals (approx. 9 weeks old)
- Housing: Animals were housed in a controlled environment individually in Macrolon cages
- Diet (e.g. ad libitum): Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): a temperature of 21.0 ± 3.0ºC (actual range: 19.7 - 22.9ºC)
- Humidity (%): a relative humidity of 40-70% (actual range: 43 - 62%)
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day.
No further information
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Group animal numbers induction (test substance; % w/w)
1 01 - 05 0 (Acetone/Olive oil (4:1 v/v))
2 06 - 10 1
3 11 - 15 5
4 16 - 20 10
- No. of animals per dose:
- Five animals per dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. Containers with pre-weighed test substance or formulations were wrapped with thin foil. No adjustment was made for specific gravity or density of the vehicle or test substance. Homogeneity was obtained to visually acceptable levels.
- Irritation: A preliminary irritation study was conducted in order to select the highest test substance concentration to be used in the main study. In principle, this concentration should be well tolerated systemically by the animals and may give moderate irritation (maximally grade 2at the highest concentration.
Initially, two test substance concentrations were tested; a 100% and 50% concentration. The highest concentration was the maximum concentration as required in the test guidelines (undiluted for liquids, 50% for solids).
The test system, procedures and techniques were identical to those used during Days 1 to 3 of the main study unless otherwise specified. Two young adult animals were selected (8-14 weeks old). Each animal was treated with one concentration on three consecutive days. Approximately 3-4 hours after the last exposure, the irritation of the ears was assessed. Bodyweights were determined on Day 3. The animals were sacrificed after the final observation and no necropsy was performed.
Based on the results of the initially treated animals, three additional animals were treated in a similar manner with three lower concentrations (5%, 10% and 25%) at a later stage
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: OECD 429
- Criteria used to consider a positive response: DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group. If the results indicate a SI ≥ 3, the test substance may be regarded as a skin sensitizer, based on the test guideline and recommendations done by ICCVAM
No further information - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No thorough statistics needed
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 7.2
- Test group / Remarks:
- test substance at 1 %
- Parameter:
- SI
- Value:
- 15.9
- Test group / Remarks:
- test substance at 5%
- Parameter:
- SI
- Value:
- 19.5
- Test group / Remarks:
- test substance at 10 %
- Parameter:
- EC3
- Value:
- > 0 - < 1
Any other information on results incl. tables
The slight irritation of the ears as shown by some animals treated at 1 and 5% and the slight to well-defined irritation in all animals treated at 10% was considered not to have a toxicologically significant effect on the activity of the nodes. No oedema was observed in any of the animals examined.
All nodes of the test substance treated animals were increased in size. The largest auricular lymph nodes were found in the higher dose groups
No macroscopic abnormalities of the surrounding area were noted in any of the animals.No macroscopic abnormalities of the surrounding area were noted. Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant. No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1A (indication of significant skin sensitising potential) based on CLP criteria
- Conclusions:
- Skin sensitizer
- Executive summary:
The authors of this study report conducted the assessment of Contact Hypersensitivity to the test substance in the Mouse (Local Lymph Node Assay). The study was carried out according to the OECD guideline n° 429 with no observed deviations or restrictions.
The test substance concentrations were selected for the main study were based on the results of a preliminary study.
In the main study, three experimental groups of five female/J mice were treated with test substance concentrations of 1, 5 or 10% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Acetone/Olive oil (4:1 v/v)).
Three days after the last exposure, all animals were injected with3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal.
After precipitating theof the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.
No oedema was observed in any of the animals examined.
All nodes of the test substance treated animals were increased in size. The largest auricular lymph nodes were found in the higher dose groups
No macroscopic abnormalities of the surrounding area were noted in any of the animals.No macroscopic abnormalities of the surrounding area were noted.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period. The slight body weight loss, noted in some animals, was considered not toxicologically significant.
Mean DPM/animal values for the experimental groups treated with test substance concentrations 1, 5 and 10% were 8538, 18776 and 23082 DPM respectively. The mean DPM/animal value for the vehicle control group was 1182 DPM.
The SI values calculated for the substance concentrations 1, 5 and 10% were 7.2, 15.9 and 19.5 respectively. These results show that the test substance elicits an SI ≥ 3. The EC3 value (the estimated test substance concentration that will give a SI =3) was established to be between 0 and 1 %.
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