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EC number: 202-044-8 | CAS number: 91-15-6
- 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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- Phthalonitrile
- EC Number:
- 202-044-8
- EC Name:
- Phthalonitrile
- Cas Number:
- 91-15-6
- Molecular formula:
- C8H4N2
- IUPAC Name:
- benzene-1,2-dicarbonitrile
- Details on test material:
- Identity: ortho-Phtalodinitrile
Batch No.: Laufprobe 26.11.2009
CAS No.: 91-15-6
Purity: 99.51 area-% (exact value is being currently analysed, BASF study code 09L00445)
Storage: At room temperature
Expiration Date: November 26, 2011
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system
Mice, CBA/CaOlaHsd
Source
Harlan Laboratories B.V. (Postbus 61745960 AD Horst / The Netherlands)
Number of animals for the pre-test
2 females
Number of animals for the main study
30 females (reserve animals will be used as needed and listed in raw data and report)
Number of animals per group
5 females (nulliparous and non-pregnant)
Number of test groups 3
Number of control (vehicle) groups 2
(If possible, concurrent controls will be used for several Harlan CCR projects performed in parallel to save animals).
Number of positive control groups 1
(If possible, concurrent controls will be used for several Harlan CCR projects performed in parallel to save animals).
Age
8 - 12 weeks (beginning of treatment)
Body weight
15 - 25 g (beginning of treatment),
Identification
Single caging.
Acclimatisation
At least 5 days prior to the start of dosing under test conditions after health examination.
Housing:
Single
Cage Type:
Makrolon Type II, with wire mesh top (EHRET GmbH, 79302 Emmendingen / Germany)
Bedding:
Granulated soft wood bedding (Rettenmaier & Söhne GmbH + Co. KG, 73494 Rosenberg / Germany)
Feed:
Pelleted standard diet, ad libitum (Harlan Laboratories B.V., 5960 AD Horst /Netherlands)
Water:
Tap water, ad libitum, (Gemeindewerke, 64380 Roßdorf / Germany)
Environment:
Temperature 22 + 2°C
Relative humidity
approx. 45-65%
Artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 0.5, 1, 2.5
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: solouble in Dimethylformamide
- Irritation: no but dermal toxicity. mortality obseved in the preexperiment
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: The animals will be distributed into the test groups at random and identified by cage number.
- Criteria used to consider a positive response: A test item is regarded as a sensitiser in the LLNA if exposure to one or more test item concentration results in a 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.).
TREATMENT PREPARATION AND ADMINISTRATION:
The test item was placed into a volumetric flask on a tared balance and dimethylformamide was quantitatively added. The different test item concentrations were prepared serially. The preparations were made freshly before each dosing occasion and used directly after preparation.
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear (left and right) with test item at concentrations of 0.5, 1, and 2.5% (w/v) in dimethylformamide or with the positive control item at 25% (w/v). The application volume, 25 µl, was spread over the entire dorsal surface of each ear once daily for three consecutive days. Two further groups of mice (control animals) were treated with an equivalent volume of the respective vehicle for the test item (dimethylformamide) or for the positive control item (acetone:olive oil (4:1)) alone. Five days after the first topical application, all mice were administered with 250 µl of 79.7 µCi/ml 3HTdR (corresponds to 19.9 µCi 3HTdR per mouse) by intravenous injection via a tail vein. Approximately five hours after treatment with 3HTdR all mice were euthanised
The draining lymph nodes were rapidly excised and pooled per animal (2 nodes per animal). Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 µm mesh size). After washing two times with phosphate buffered saline (approx. 10 ml) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 ml) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 ml) and transferred to plastic scintillation vials with 10 ml of ‘Ultima Gold’ scintillation liquid (Perkin Elmer (LAS) GmbH, 63110 Rodgau, Germany) and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a cintillation counter. Similarly, background 3HTdR levels were also measured in two 1ml-aliquots of 5 % trichloroacetic acid. The scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
Additionally: After the lymph nodes had been excised, both ears (left and right) of mice were punched at the apical area using a biopsy punch (Stiefel, Ø 8 mm corresponding to 0.5 cm2). For each animal both punches were immediately weighed per animal using an analytical balance. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables. A statistical analysis was conducted to assess whether the difference is statistically significant between test item groups and negative control (vehicle) group and also to assess if there is a dose response relationship. For all statistical calculations SigmaStat for Windows (Version 2.0) was used. A One-Way-Analysis-of-Variance was used as statistical method. In case of significant results of the One-Way-ANOVA, multiple comparisons were performed with the Dunnett test or the Student Newman Keuls test.
However, the primary point of consideration was the biological relevance of the results.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Stimulation Indices (S.I.) of 1.29, 1.36, and 1.18 were determined with the test item at concentrations of 0.5, 1, and 2.5% (w/v) in dimethylformamide, respectively. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3. The S.I. of the positive control group was 7.48.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: A statistically significant difference in DPM/animal was not observed in any of the groups treated with different concentrations of the test item in comparison to the vehicle control group (see table below).
Any other information on results incl. tables
Calculation of Stimulation Indices per Dose Group
Test item concentration |
Mean DPM per Group (5 animals)a) |
SDb) |
S.I. |
Vehicle for the Test Item (dimethylformamide) |
758.9 |
396.7 |
1.00 |
5% ortho-Phthalodinitrile |
978.7 |
223.4 |
1.29 |
10% ortho-Phthalodinitrile |
1029.5 |
217.9 |
1.36 |
25% ortho-Phthalodinitrile |
898.1 |
454.7 |
1.18 |
Vehicle for the Positive Control (acetone:olive oil (4+1)) |
857.7 |
196.7 |
1.00 |
25% Positive Control |
6416.1 |
1837.4 |
7.48 |
a) Mean DPM/Group was determined by dividing the sum of the measured values from lymph nodes of all animals within a group by the number of animals in that group (5 animals)
b) SD=Standard deviation
The EC3 value could not be calculated, since all S.I.´s are below 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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