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EC number: 285-480-1 | CAS number: 85099-25-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is GLP and follows the OECD guideline 429 although there is no information on analysis of the test material, dosing and progress inspections.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- (1) No in-progress inspection (2) No analysis of test material and dosing solutions
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- CAS #98-94-2, Air Products and Chemicals, Lot #AW4 10736M4
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- Female BALB/c mice, supplied by Charles River, were used throughout this study. The mice were ordered, as needed, and the age of the mice ranged from 9 to 11 weeks. The mice were identified by marking the tails with permanent ink applied from felt-tip pens. A system of different colored inks, hash marks on the tail and, either underlining the number or marking an additional hash mark on the tip of the tail, was used to ensure that each mouse in the test was uniquely identified. The same color of tape, which contained additional information as necessary to maintain the unique identity, was placed over the appropriate animal cage.The animals were housed singly in wire bottom cages suspended above catch pans containing absorbent cageboard. The cages were sanitized and cageboards changed regularly in accordance with good husbandry practices. The cages contained stainless steel feeders filled with Purina Certified Rodent Chow #5002 and a pressure-activated, stainless steel water nipple attached to an automatic water line. The testing facility has been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). The animal rooms of the testing facility are designed to maintain adequate environmental conditions concerning temperature, humidity, and photocycle and are regulated for the species under test. The temperature is set at 22 ± 1°C, the humidity is set at 50 ± 10% RH and the light/dark cycle is set at 12 hours on: 12 hours off. Alarms are set to sound if the temperature is lower than 19 °C or higher than 25 °C and/or the relative humidity is lower than 39% or higher than 71 %. These limits are based on AAALAC recommendations.Feed analysis is performed by Purina Mills, Inc. to confirm that the diet provides adequate nutrition and to quantify the levels of selected contaminants associated with the formulation process. Analysis of the tap water (municipal water supply) is performed in accordance with Laboratory Standard Operating Procedures.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- The amine catalyst was tested in the LLNA at the minimal irritating concentration (MIC). The MIC was determined in previous Primary Dermal Irritation Study (PDIS) as the effective concentration causing a 10% ear swelling (EC10). CAS #98-94-2 was tested at 30% in AOO in the LLNA test.
- No. of animals per dose:
- 5 animals/dose; tested in duplicate
- Details on study design:
- The Local Lymph Node Assay (LLNA) was used to assess the potential of the test article to cause skin sensitization. The amine catalyst was tested in the LLNA at the minimal irritating concentration (MIC). The MIC was determined in previous Primary Dermal Irritation Study (PDIS) as the effective concentration causing a 10% ear swelling (EC10). This study consisted of two separate trials. Each trial contained a vehicle control group (5 mice treated with a solution of 4:l acetone:olive oil, AOO), three positive control groups (5 mice treated with a solution of each 1.0% dinitrochlorobenzene (DNCB), 0.17% benzalkonium chloride (BC), and 25% trimellitic anhydride (TMA), and test article treatment group (5 mice treated with a 30% solution of the amine catalyst in AOO). The choices of AOO as the vehicle carrier and the three positive controls (DNCB, BC, and TMA) were based on historical data generated in the laboratory. Prior to the application of the solutions on Day 1, an erythema score was assessed for each mouse (grading scale 0 to 4). The solutions were applied by dispensing 12.5 µl of the appropriate solution onto the dorsal and ventral side of each ear using an automatic pipet. Each ear received a total of 25 µl of solution for a total of 50 µl per mouse. The solutions were applied once daily for three consecutive days. On Day 5, prior to injection with 3H-thymidine, the erythema score was assessed for each mouse. Each mouse was then injected, via the lateral tail vein, with 0.2 ml of phosphate buffered saline (PBS) containing 20 µCi of 3H-thymidine. Five hours after the injections, the mice were sacrificed by C02 inhalation and the draining auricular lymph nodes were excised and pooled for each mouse. A single cell suspension of lymph node cells (LNC) was prepared and 3H-thymidine incorporation was measured on a ß-scintillation counter. Radioisotope incorporation was measured as disintegrations per minute (dpm) per mouse and a mean dpm value +/- SE (standard error) was calculated for each experimental group. In addition, a stimulation index (SI) was calculated using absolute dpm value for each mouse as the numerator, and the mean dpm value from the vehicle control mice as the denominator. A mean SI +/- SE was calculated for each experimental group. Historically, any chemical that produces a SI of > 3 in the LLNA is considered "positive".
- Positive control substance(s):
- other: 25% trimellitic anhydride (TMA)... (see attached file)
- Statistics:
- Calculations were made using Microsoft Excel. The following equations were used:1. SI = dpm of mouse mean dpm of vehicle group2. AVERAGE* = "average" of numbers3. STDEV* = "estimates standard deviation of a population based on a sample"4. Standard Error (SE) = STDEV s the square root of the number of mice in group*Defined by Microsoft Excel
Results and discussion
- Positive control results:
- BC showed a mean erythema score on day 5 of 0, which is consistent with the fact that 0.17% is the MIC. One percent DNCB showed a mean erythema score of 1.0. 25% TMA showed a mean erythema score of 2 on day 5. Both of the sensitiser positive controls produced a robust response with a simulation index (SI) > 70.0. BC triggered a SI which was greater than 3.0 would be considered positive.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.27
- Variability:
- 0.4
- Test group / Remarks:
- 30%
- Key result
- Parameter:
- SI
- Value:
- 2.45
- Variability:
- 0.6
- Test group / Remarks:
- 30%
Any other information on results incl. tables
CAS #98-94-2 was first assayed on November 14, 1996. Erythema was graded based on a grading scale of 0 to 4, with a score of 1 for DCNB and 2 for TMA. There was no irritation (i.e., all erythema scores were 0) at the specified doses for the test article. BC, the irritant positive control, showed a mean erythema score on Day 5 of 0, which is consistent with the fact that 0.17% is the MIC. One percent DNCB showed a mean erythema score of 1.0 and 25% TMA showed a mean erythema score of 2.0 on Day 5. For the results of the LLNA both of the sensitizer positive controls produced a robust response with SI's > 70.0. BC triggered a SI which was greater than 3.0 and would be considered a "positive". The criteria for a SI > 3.0 is based on historical results which recognize that a strong irritant can trigger proliferation in the draining lymph node. The results of the erythema scores indicate no irritation (i.e., all erythema scores were 0) at the specified dose. BC, the irritant positive control, showed a mean erythema score on Day 5 of 1.8, which is consistent with the fact that 0.17% is the MIC. One percent DNCB showed a mean erythema score of 3.0 and 25% TMA showed a mean erythema score of 3.0 on Day 5. For the results of the LLNA the SI for the positive controls: SI of 3.28 for 0.17% BC, SI of 40.90 for 1.0% DNCB, and SI of 41.07 for 25% TMA are consistent with previous results. Both of the sensitizing positive controls produced robust responses. BC, the irritant positive control, also produced a SI > 3.0 in these two trials which would trigger a determination that it was "positive" in these two assays. The criteria that a chemical must trigger a SI > 3.0 is based on historical results which recognize that an irritant can trigger a proliferation in the draining lymph node. The SI for the amine catalyst was not greater than 3.0, indicating it is not a sensitizer.
Table 1. Summary of Erythema Results for November 14, 1996:
Group |
Concentration |
Erythema Score (Day 5) |
DCNB |
1.0% |
1.0 |
BC |
0.17% |
0 |
TMA |
25% |
2.0 |
CAS 98-94-2 |
30% |
0 |
Table 2. Summary of LLNA Results for November 14, 1996:
Group |
Concentration |
SI (Mean +/- SE) |
DCNB |
1.0% |
74.16 +/- 7.20 |
BC |
0.17% |
4.77 +/- 1.19 |
TMA |
25% |
72.55 +/- 7.65 |
CAS 98-94-2 |
30% |
1.27 +/- 0.40 |
Table 3. Summary of Erythema Results for February 10, 1997:
Group |
Concentration |
Erythema Score (Day 5) |
DCNB |
1.0% |
3.0 |
BC |
0.17% |
1.8 |
TMA |
25% |
3.0 |
CAS 98-94-2 |
30% |
0 |
Table 4. Summary of LLNA Results for February 10, 1997:
Group |
Concentration |
SI (Mean +/- SE) |
DCNB |
1.0% |
40.90 +/- 3.89 |
BC |
0.17% |
3.28 +/- 0.45 |
TMA |
25% |
41.07 +/- 5.27 |
CAS 98-94-2 |
30% |
2.45 +/- 0.62 |
Overall SI Mean for CAS #98-94-2: 1.86 ± 0.40.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The results from two separate trials indicate that amine catalyst DMCHA did not produce a positive response, and it is concluded that this catalyst is not a skin sensitizer according to the LLNA when tested at minimally irritating concentrations.
- Executive summary:
The Local Lymph Node Assay (LLNA) was used to assess the potential of ten amine catalysts as respiratory sensitizers. The amine catalysts were tested in the LLNA at the minimal irritating concentration (MIC). The MIC was determined in previous Primary Dermal Irritation Studies (PDIS) as the effective concentration causing a 10% ear swelling (EC10). For the amine catalysts where an ECl0 could not be calculated, the materials were tested at the highest concentration which did not trigger an increase in ear swelling. The minimal irritating concentration for cyclohexyldimethylamine (DMCHA) was determined to be 30%. The activity of the amine catalysts were compared to three positive controls: 1.0% dinitrochlorobenzene (DNCB), a known dermal sensitizer, benzalkonium chloride (BC), a known irritant (0.17% is the EC 10 for this chemical), and 25% trimellitic anhydride (TMA), a known respiratory sensitizer. In the studies, mice (5 mice per experimental group) were dermally exposed to test materials, positive control material, or vehicle (4:l acetone:olive oil) for three consecutive days. All mice received 12.5 µl of the test material, positive controls, and vehicle on the dorsal and ventral sides of both ears for a total of 50 µl per day. Erythema, an indication of dermal irritation, was assessed for each mouse on Days 1 and 5 of the study. Five days after the initiation of the study, all mice received an intravenous injection, via the lateral tail vein, of 0.2 ml phosphate buffered saline containing 20 µCi of tritiated thymidine (3H -thymidine). Five hours after injection, the mice were sacrificed by CO2inhalation and the draining auricular lymph nodes were excised. A single cell suspension of lymph node cells (LNC) was prepared and 3H-thymidine in corporation was measured on a p-scintillation counter. Radioisotope incorporation was measured as disintegrations per minute (dpm) per mouse and a mean dpm value ± SE (standard error) was calculated for each experimental group. In addition, a stimulation index (SI) was calculated using absolute dpm value for each mouse as the numerator, and the mean dpm value from the vehicle control mice as the denominator. A mean SI±SE was calculated for each test material from two separate trials (5 test materials were studied in each of four trials).The overall mean SI ± SE for DMCHA is 1.86 ± 0.4 along with MI. The test substance has a simulation index below 3. Therefore, for DMCHA does not warrant any classification according to Directive 67/548/EEC and Regulation (EC) No 1272/2008.
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.
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