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EC number: 610-122-1 | CAS number: 433733-94-9
- 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
LDT600 C3 appeared to be a weak sensitizer with no irritating potential in the murine LLNA TIER I.
According the criteria described in CLP Directive EEC 1272/2008 the tested material has to be classified as a skin sensitizer Cat. 1 (H317).
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:
- 27.4. - 14.5.2009
- 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
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 17 - 20 g
- Housing: Animals were housed in groups of 3 in Macrolon cages (MIII type) with sterilized saw dust as bedding material and paper as cage enrichment.
- Diet: SSNIFF SM R/M-Z pelleted rodent diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 23.4
- Humidity (%): 41 - 61
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 27.4.2009
To: 14.5.2009 - Vehicle:
- dimethylformamide
- Concentration:
- 50%, 5%, 0.5% (w/w)
- No. of animals per dose:
- 6
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
The dorsal surface of both ears was epidermally treated (25 μl/ear) with the test substance concentration, approximately the same time each day, for three consecutive days. The concentrations were mixed thoroughly using a vortex mixer immediately prior to dosing. The control animals were treated in the same way as the test substance groups, except that, instead of the test substance, the vehicle or positive control substance was administered.
Approximately 24 h after the last treatment, all animals were sacrificed by intraperitoneal injection with pentobarbital. Both ears (left and right) were punched in the apical area using a biopsy punch. For each animal both punches were immediately weighed pooled per animal using an analytical balance after which the punches were discarded.
Both auricular draining lymph nodes (left and right) of mice were excised. The relative sizes of the nodes (as compared to normal) were estimated by visual examination and abnormalities of the nodes and surrounding area were recorded. For each animal both lymph nodes were pooled and immediately weight using an analytical balance.
Following excision and weighing of the nodes, single cell suspensions of lymph node cells (LNC) were prepared in phosphate buffered saline (PBS) by gentle separation through stainless steel gauze. LNC were collected in approximately 0.7 mL of PBS in a 24 wells plate that was kept on ice as much as possible.
Cell counts were determined using a Coulter Counter Z1 Dual. - Positive control substance(s):
- other: 0.5% 1-Chloro-2,4-Dinitrobenzene (DNCB)
- Positive control results:
- The positive control item DNCB elicited a reaction pattern with increased LN hyperplasia, which was in congruence with the expected mode of action of a contact allergen.
- Key result
- Parameter:
- other: Ear weight index
- Value:
- 1
- Test group / Remarks:
- Dimethyl formamide
- Key result
- Parameter:
- other: Ear weight index
- Value:
- 1.02
- Test group / Remarks:
- 0.5% DNCB
- Key result
- Parameter:
- other: Ear weight index
- Value:
- 1
- Test group / Remarks:
- 0.5% of the test substance LDT600 C3
- Key result
- Parameter:
- other: Ear weight index
- Value:
- 0.92
- Test group / Remarks:
- 5% of the test substance LDT600 C3
- Key result
- Parameter:
- other: Ear weight index
- Value:
- 1
- Test group / Remarks:
- 50% of the test substance LDT600 C3
- Key result
- Parameter:
- other: LN weight index
- Value:
- 1
- Test group / Remarks:
- Dimethyl formamide
- Key result
- Parameter:
- other: LN weight index
- Value:
- 2
- Test group / Remarks:
- 0.5% DNCB
- Key result
- Parameter:
- other: LN weight index
- Value:
- 1.07
- Test group / Remarks:
- 0.5% of the test substance LDT600 C3
- Key result
- Parameter:
- other: LN weight index
- Value:
- 0.95
- Test group / Remarks:
- 5% of the test substance LDT600 C3
- Key result
- Parameter:
- other: LN weight index
- Value:
- 1.18
- Test group / Remarks:
- 50% of the test substance LDT600 C3
- Key result
- Parameter:
- SI
- Remarks on result:
- not measured/tested
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LDT600 C3 appeared to be a weak sensitizer with no irritating potential in the murine LLNA TIER I.
According the criteria described in CLP Directive EEC 1272/2008 the tested material has to be classified as a skin sensitizer Cat. 1 (H317).
Reference
The test doesn`t include a determination of DPM, but analysis of ear weight, increasing of LN cell counts, increase in LN cell weight and body weight. A substance is considered as a sensitizer, if an increasing of LN cell counts as well as LN cell weight can be observed.
No visual irritation of the ears was noted for the vehicle control group and groups treated with the test substance. The animals of the positive control group showed slight erythema. Visual examination of the nodes revealed that the majority of nodes were considered normal in size, except for the nodes of one animal at 0.5% and two animals at 5%, which were considered reduced in size. All nodes of the positive control animals were considered enlarged when compared to the vehicle control group. No macroscopic abnormalities of the surrounding areas were noted in any of the animals.
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period and no clinical signs were observed.
The positive control item DNCB elicited a reaction pattern with increased LN hyperplasia, which was in congruence with the expected mode of action of a contact allergen.
The tested material did not cause any change in ear weight when compared to the vehicle control. The tested material did cause a dose related increase in LN cell counts when compared to the vehicle control. The tested material did not cause a dose related increase in LN weights when compared to the vehicle control.
In conclusion, the tested material appeared to be a weak sensitizer with no irritating potential in the murine LLNA TIER I.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.
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