Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
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
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- CAS No.: 078567-28-9; Batch No.: WDJ 1853 D-3; Appearance: clear liquid
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- Adaptation: after their arrival, the animals intended for the study were allowed to adapt to the conditions of the animal room for at least 7 days and their state of health was monitored,
Health status: only healthy animals showing no signs of disease were used in the study. The animals were not vaccinated or treated with antiinfectives either before their arrival or during the adaptation or study period. The females were nulliparous and nonpregnant.
Age and Body weight: the mice exhibited a weight of 26 — 32 grams at the beginning of the study. The age of the animals was 8 — 9 weeks.
Housing of the animals:
During the adaptation period the animals were housed in conventional Makrolon type HI cages up to 8 mice and during the study period in type II cages, one animal being kept in each cage. The cages were changed at least twice a week.
Low-dust wood granulate from J. Rettenmaier & Sane Ftillstoff-Fabriken, Germany, was used as bedding. At the instigation of the Laboratory Animal Services (LAS) the wood granulates was analyzed at random for contaminants.
At times animals taking part in other toxicological studies were kept in the same room, but adequate spatial separation and appropriate organization of the work procedures ensured that animals could not be confused.
Room temperature: 22 ± °C
Relative humidity: 40 – 70 %
Light/dark cycle: 12h/12h with artificial illumination
Air throughput: about 10 changes per hour
Diet: PROVIMI KLIBA SA 3883 maintenance diet for rats and mice and tap water (drinking water) provided ad libitum. - Vehicle:
- methyl ethyl ketone
- Concentration:
- The concentrations of 0 %; 3 %; 10 % and 30 % of the test substance.
- No. of animals per dose:
- 6
- Details on study design:
- Modified Local Lymph Node Assay (IMDS):
A modification of the assay by measuring the cell counts instead of radioactive labeling provides comparable sensitivity, and has the advantage that the cell suspension can be further analysed by different methods (flow cytometry, chemiluminescence responses, immunofluorescence) to gain an insight into mechanistic events.
A further modification was done by including the measurement of the ear swelling after treatment leading to a much more simplified and reliable assay (Integrated Model for the Differentiation of Skin reactions (IMDS). By comparing the specific immune reaction induced by the test substance in the draining lymph nodes (LN; cell counts / LN weights) with the immediate unspecific acute skin reaction (ear swelling / ear weight) it is possible to discriminate the irritating potential from the sensitizing potential of the compound tested.
The test substance was applied epicutaneously onto the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days. The volume administrated was 25 µL/ear. The animals were anaesthetized by inhalation of the carbon dioxide and sacrificed one day after last application (day 4). The appropriate organs were then removed. Lymphatic organs (the auricular lymp nodes) were transferred into PBS.
LLN weigh and cell count determination:
The weights of the lymph nodes were determined on a Mettler semiautomatic balance and stored in a IBM compatible PC. After crushing the lymph nodes through a plastic sieve in a 12-well plate, the cell counts per ml were determined using a Culter Counter. These data were also processed by the computer. Special BASIC programs (GWBASIC complier) were used to calculate indices, means and standard deviations.
The so called stimulation or LLN- index is calculating by dividing the absolute number of weight or cell counts of the substance treated lymph nodes by the vehicle treated ones.
The samples (cell suspensions) of this study have been analysed by flow cytometry (FACScan) in addition.
Ear swelling: Before the first treatment and before sacrifice the thickness of both auricles of the animals was measured using a spring-loaded micrometer.
Ear weight: on day 4 te ear weight o the sacrificed animals was measured using a punch to take of the piece of every ear wit a diameter of 8 mm.
Body weight: the body weights of the animals were recorded initiating the and at the end of the study. - Key result
- Parameter:
- other: cell counts
- Value:
- 1.3
- Test group / Remarks:
- all test groups, statistical significance in mid and high test group
- Key result
- Parameter:
- other: ear swelling
- Remarks:
- [mm]
- Value:
- 0.02
- Test group / Remarks:
- high dose group
- Key result
- Parameter:
- SI
- Remarks on result:
- not measured/tested
- Cellular proliferation data / Observations:
- The results show that the test substance has a sensitizing potential in mice after dermal application.
- Compared to vehicle treated animals there was a clear increase regarding the weights of the draining lymph nodes, that is of statistical significance in the highest dose group and a clear increase in the cell counts in the mid and highest dose group.
- The "positive level" of index 1.3 was exceeded for the cell counts in all dose groups.
- A significant increase compared to vehicle treated animals regarding ear swelling (2-E2 mm) and ear weight was detected in the mid and the highest dose group. An increase in this parameter to point of an acute irritating (inflammatory) response. However, such an irritating property is also combined with a strong skin sensitizing potential of a test substance. - Interpretation of results:
- other: CLP
- Remarks:
- classified as 1B sensitizer
- Conclusions:
- Under the study conditions, the test substance was considered to be sensitising to skin.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 429 (modified Local Lymph Node Assay), EU Method B.42 and EPA OPPTS 870.2600. Four groups of 6 female NMRI mice of the strain Hsd Win:NMRI were treated at concentrations of 0 %, 3%, 10% and 30% of the test substance formulated in methyl ethyl ketone (MEK). The test substance was applied epicutaneously on the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days. Following exposure, the animals were anaesthetized by inhalation of carbon dioxide and sacrificed one day after last application (Day 4). The ear lymph nodes were then removed and transferred into phosphate buffered saline. Compared to vehicle treated animals there was a clear increase in the weights of the draining lymph nodes (statistically significant in the highest dose group). Also, there was a clear increase in the cell counts in the mid and highest dose groups. The cell count index exceeded 1.3 in all dose groups. The ear swelling and ear weight was also increased in the mid and the highest dose groups. Under the study conditions, the test substance was considered to be sensitising to skin (Vohr, 2003).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A study was conducted to determine the skin sensitisation potential of the test substance according to OECD Guideline 429 (modified Local Lymph Node Assay), EU Method B.42 and EPA OPPTS 870.2600. Four groups of 6 female NMRI mice of the strain Hsd Win:NMRI were treated at concentrations of 0 %, 3%, 10% and 30% of the test substance formulated in methyl ethyl ketone (MEK). The test substance was applied epicutaneously on the dorsal part of both ears of the animals. This treatment was repeated on three consecutive days. Following exposure, the animals were anaesthetized by inhalation of carbon dioxide and sacrificed one day after last application (Day 4). The ear lymph nodes were then removed and transferred into phosphate buffered saline. Compared to vehicle treated animals there was a clear increase in the weights of the draining lymph nodes (statistically significant in the highest dose group). Also, there was a clear increase in the cell counts in the mid and highest dose groups. The cell count index exceeded 1.3 in all dose groups. The ear swelling and ear weight was also increased in the mid and the highest dose groups. Under the study conditions, the test substance was considered to be sensitising to skin (Vohr, 2003).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available in vivo LLNA study with the test substance indicated increase in ear swelling and ear weight accompanied by increase in the cell count index above 1.3 in the treated mice. Based on a conservatice approach, th test substance warrants a classification of Skin sens. 1B (H317: May cause an allergic reaction).
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.