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EC number: 235-868-1 | CAS number: 13014-18-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,4-dichloro-1-(trichloromethyl)benzene
- EC Number:
- 235-868-1
- EC Name:
- 2,4-dichloro-1-(trichloromethyl)benzene
- Cas Number:
- 13014-18-1
- Molecular formula:
- C7H3Cl5
- IUPAC Name:
- 2,4-dichloro-1-(trichloromethyl)benzene
- Test material form:
- solid: crystalline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca Ola Hsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TOXI-COOP ZRT. H-1103, Budapest, Cserkesz u. 90., Hungary
- Age at study initiation: young adult mice, 8-12 weeks (at start of the experiment)
- Weight at study initiation: 19.2 -24.2 g
- Housing: during the test: grouped caging (4 animals/cage)
- Cage type: Type II. polypropylene/polycarbonate
- Diet: ssniff® SM R/M-Z+H complete diet for rats and mice ad libitum
- Water: tap water ad libitum
- Acclimation period: 14 or 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity (%): 30 – 70
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- First Pre-test: 100 % (i.e. 1 g/mL), 50 % and 25 % (w/v) prepared with DMF
Second Pre-test: 10 %, 5 %, 2.5 % or 1 % (w/v) formulations in DMF
Main experiment: 10 %, 5 %, 2.5 % or 1 % (w/v) formulations in DMF - No. of animals per dose:
- Pre-tests: 2 animals per test concentration
Main experiment: 4 animals per dose group - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: pre-experiments on solubility of the test item were performed following the recommendation of the relevant guidelines
- Irritation: Two dose range finding test were performed at concentrations of 100 % , 50 %, 25 % 10 %, 5 %, 2.5 % or 1 % (w/v) formulations in DMF. Eventual signs of local irritation were documented and the ear thickness was determined.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Proliferative response of the lymph node cells
- Criteria used to consider a positive response:
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice (stimulation index SI ≥ 3 )
TREATMENT PREPARATION AND ADMINISTRATION:
- each mouse was topically treated with 25 µL of the appropriate formulations of the test item, of the positive control substance and of the vehicles
- the formulations were applied with a pipette, on the dorsal surface of each ear
- each animal was dosed once a day for three consecutive days (Days 1, 2 and 3) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Significance of the dose-response was evaluated by linear regression and regression curve analysis was also used for calculation of EC3 values.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks:
- 10 %
- Value:
- 12.4
- Test group / Remarks:
- 2 animals
- Parameter:
- SI
- Remarks:
- 5 %
- Value:
- 8.1
- Test group / Remarks:
- 2 animals
- Parameter:
- SI
- Remarks:
- 1%
- Value:
- 2.9
- Test group / Remarks:
- 2 animals
Any other information on results incl. tables
Pre-tests
In the first preliminary test mortality was observed in the 100 % (w/v) dose group (1/2 animals) on Day 5. Due to the significant systemic effect (sever decreased activity, hunched back posture, piloerection, tremor, lying on cage floor were observed) the other animal was considered moribund and humanely killed on the same day. In the 50 % (w/v) dose group the following systemic effects were observed: decreased activity (2/2 animals, from Day 4 to Day 6 for one animal or on Day 6 for the other animal) and piloerection (1/2 animals, on Days 4 and 5). Additionally the mean body weight decreased by 7 % in this dose group. In the 25 % (w/v) dose group no significant loss of body weight, but decreased activity (2/2 animals, on Day 6) was observed. In the 50 % and 25 % (w/v) dose groups scab (observed at the base of ears, 2/2 animals in both groups) and significantly (≥ 25 %) increased ear thickness (1/2 animals and 2/2 animals in the 50 % and 25 % (w/v) dose groups, respectively) with a maximum value of 55 % were also observed. These effects were considered as indication of an irritation effect although no significant erythema (scored as ≥ 3) was observed at the treatment site (ears) at the tested concentrations. Due to the observed significant adverse effects a subsequent preliminary test was performed with lower test concentrations.
In the second preliminary test no mortality was observed during the second preliminary test. No significant, treatment related effect on the body weights was observed in any treatment groups. No other signs of systemic toxicity were observed in any treatment group. As a local effect exfoliation (2/2 animals) and scab (1/2 animals) were observed in the 10 % (w/v) dose group, although no significant erythema (scored as ≥ 3) or significantly (≥ 25 %) increased ear thickness were observed at the treatment site (ears) at the tested concentrations. The observed effects at 100 %, 50 %, 25 % (w/v) concentrations were considered excessive.
Although the observations at 10 % (w/v) concentration (exfoliation and scab) could indicate a possible irritation, it was considered not excessive since no other obvious signs of irritation (erythema and/or increased ear thickness) were observed. Based on this 10 % (w/v) concentration was selected as the maximum concentration in the main test in order to test the highest concentration possible.
Main test
Body weight measurements:
No significant, treatment related effect on the body weights was observed in any treatment group. Clinical observations and signs of irritation: No mortality or symptoms of systemic toxicity were observed in any treatment group. No sign of irritation (indicated by an erythema score 3) or any other local effect was observed in any treatment group.
Proliferation assay:
The lymph nodes in the positive control group were larger than the relevant control (AOO). Visually larger lymph nodes compared to the relevant control (DMF) were observed in the 10 % and 5 % (w/v) test item treated groups. Visual appearance of the lymph nodes was normal in the negative (vehicle) control groups (both AOO and DMF) and in the other test item treated groups (2.5 % and 1 %, w/v). Significant lymphoproliferation (SI ≥ 3) was observed for the test item at concentrations of 10 %, 5 % and 2.5 % (w/v). The corresponding stimulation index values were 12.4, 8.1, 3.6 and 2.9 at treatment concentrations of 10 %, 5 %, 2.5 % and 1 % (w/v), respectively. The calculated EC3 value was 1.2 % (w/v) in this LLNA.
The positive control substance induced the appropriate stimulation compared to the control (SI = 22.2).
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present Local Lymph Node Assay, the test item tested up to the maximum applicable (non-toxic, non-irritant) concentration of 10 % (w/v) was shown to have skin sensitization potential.
Based on the results obtained from testing the test item has to be classified as Skin Sens 1A, H317 according to Regulation (EC) No 1272/2008 (CLP).
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