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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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 April - 11 may 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and EC guidelines and according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Description: Bright yellow powder
Test substance storage: At room temperature in the dark
Stability under storage conditions: Stable
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Species: Mouse, CBA strain, inbred, SPF-Quality.
Source: Charles River France, L’Arbresle Cedex, France.
Number of animals: 25 females (nulliparous and non-pregnant), five females per group.
Age and bodyweight: Young adult animals (approx. 12 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.
Weight at study initiation: 23-27 grams
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 21.2 – 24.0ºC), a relative humidity of 40-70% (actual range: 39 - 56%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accommodation
Individual housing in labeled Macrolon cages (MI type; height 12.5 cm) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France). Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom) was supplied as cage-enrichment.
The paper was removed on Day 1 prior to dosing and was supplied again after scoring of the ears on Day 3.
Acclimatization period
The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. Accommodation was as described above except that the animals were group housed in Macrolon cages (MIII type; height 18 cm).
Diet
Free access to pelleted rodent diet
Water
Free access to tap water.
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/Water (7:3 (v/v))
- Concentration:
- 5%, 10% and 25%
- No. of animals per dose:
- 5
- Details on study design:
- Three groups of five experimental animals were treated with test substance concentrations of 5%, 10% or 25% on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with vehicle alone (Ethanol/Water 7:3 (v/v)) and five positive control animals were similarly treated, but with positive control substance.
Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of 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. - Positive control substance(s):
- other: 0.5% 1-Chloro-2,4-Dinitrobenzene
Results and discussion
- Positive control results:
- The SI value calculated for 0.5% 1-Chloro-2,4-Dinitrobenzene in Ethanol/Water (7:3 (v/v)) was 65.5 and no systemic toxicity was observed for Ethanol/Water (7:3 (v/v)). Therefore, Ethanol/Water (7:3 (v/v)) was proved suitable as vehicle in the Local Lymph Node Assay performed at NOTOX.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 2 5% 0.9 ± 0.3 3 10% 0.9 ± 0.3 4 25% 1.0 ± 0.2 1 0% (Vehicle) 1.0 ± 0.3
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0% (Vehicle) 251 ± 51 5% 228 ± 50 10% 224 ± 55 25% 240 ± 22
Any other information on results incl. tables
Yellow test substance remnants prevented scoring for erythema. No oedema was observed in any of the test substance-treated animals examined. Slight to well-defined erythema was observed in all animals of the positive control group and no skin irritation was observed in the control animals. The irritation of the ears as shown by the animals was considered not to have a toxicologically significant effect on the activity of the nodes.
All nodes of the experimental and vehicle control groups were considered normal in size, except for one node at 10% which was considered reduced in size. All nodes of the positive control group were considered enlarged in size.
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.
Reliability check:
The SI values calculated for the HCAs 5, 10 and 25% were 2.0, 2.2 and 4.2 respectively. An EC3 value of 16.0 % was calculated using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 2 and 20%. Theresults of the 6 monthly reliability checks of the recent years were 13.1, 15.6, 14.1, 13.8 and 13.9%.
Based on the results, it was concluded that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivityApplicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Since there was no indication that the test substance could elicit an SI >= 3 when tested up to 25%, it was established that the EC3 value (if any) exceeds 25%.
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