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EC number: 244-343-6 | CAS number: 21351-39-3
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end on 13-SEP-2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. However a corrosive effect was observed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- modified as IMDS test
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Uronium hydrogen sulphate
- EC Number:
- 244-343-6
- EC Name:
- Uronium hydrogen sulphate
- Cas Number:
- 21351-39-3
- Molecular formula:
- CH4N2O.H2O4S
- IUPAC Name:
- hydrogen [amino(hydroxy)methylidene]azanium sulfate
- Details on test material:
- - Name of test material (as cited in study report): aduct urea-sulfuric
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: dry, ventilated well, away from inflammable materials
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: from the company Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 26 to 32 g
- Housing: transparent macrolone cages (type 150, floor area 810 cm2) with 6 animals in each cages
- Diet: a pelleted complete rodent diet "Altromin 1324", ad libitum
- Water: free access to bottles of drinking water of domestic quality, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3°C
- Humidity: at least 30% and preferably not exceed 70%
- Air changes: 10 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: the experimental phase was carried out between July 20th, 2010 and July 23th, 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100% (v/v)
- No. of animals per dose:
- 6 animals per dose
- Details on study design:
- RANGE FINDING TESTS: no pre-test was performed. The dose levels were chosen based on existing acute toxicity and dermal irritation (with conclusion that the test substance was not acutely toxic and not irritant to the skin in the rabbit).
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA / IMDS
- Criteria used to consider a positive response:
a differentiation index (DI) is calculated from the different parameters of investigation which describes the relation between the activation of the local skin-draining lymph nodes and the skin inflammation at the site of topical treatment as well as it contributes to distinguish between inflammatory (non-specific) and allergic (specific) reaction:
- 0 < DI < 1 : inflammation
- DI > 1 : allergic reaction
DI = (% max. LN cell count index increase) / (% max. ear thickness increase)
TREATMENT PREPARATION AND ADMINISTRATION:
Twenty-four albino mice of the strain Crl:NMRI in groups consisting of six animals each were treated with three concentrations of the test item (100%, 50% and 25% v/v) or only with the vehicle acetone/olive oil (4/1 v/v) on three consecutive days. An amount of 25µL of the test substances was applied on the dorsal side of each ear. - Positive control substance(s):
- not specified
- Statistics:
- data not available
Results and discussion
- Positive control results:
- The last positive test results was registered in August 2009 with differentiation index (DI) of 1.63 and 1.64
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see table
Any other information on results incl. tables
In contrast to the information known on the substance (i.e. no irritation by skin contact in the rabbit, no irritation observed in the acute oral and dermal test) a severe irritant effect of the test item Aduct urea-sulfuric was revealed.
On day 3 of the study, only a few animals of the test groups with concentrations of 50% and 25% showed initially well defined irritation in the form of necrotic changes of the ear skin. But on the end of the study (day 4), a damage of the epidermis was discernible in almost all animals (14 out of 18 mice) of the three test groups.
This observation of a severe irritant effect of the test item was confirmed by the evaluation of the measured data referring to the ear thickness and number of lymph node cells.
The animals of the control and test groups showed a stagnating or declining development of the body weight reflecting the disturbed general state of health of the animals during the study. A positive increase of ear thickness was shown in all three test groups compared to the negative control. The weight determination of ear tissue showed also an increase in all three test group in comparison to the negative control. A slight increase of the weights of the lymph nodes compared to the negative control was only recorded for that test group, which was treated with the 100% test item. An increase of the proliferation was recorded in all three test groups. But the positive threshold value concerning the index of the number of LN cells was passed only in the case of the test groups treated with the test concentrations of 100% and 25%.
Table 1: calculation of means, standard deviations and indices for the increase of the ear thickness, for the weight of the ear tissue and lymph nodes as well as for the number of lymph node cells:
Parameter of investigation |
Negative control |
Aduct Urea-Sulfuric |
|||
100% |
50% |
25% |
|||
Increase of ear thickness |
M of ear thickness on day 4 (mm) |
0.20 |
0.23 |
0.23 |
0.23 |
SD of ear thickness on day 4 (% M) |
3 |
6 |
4 |
6 |
|
Index of ear thickness derived from the comparison of groups on day 4 |
1.00 |
1.15 |
1.12 |
1.15 |
|
Weight of ear |
M (g) |
0.0097 |
0.0203 |
0.0185 |
0.0194 |
SD (% M) |
7 |
17 |
22 |
10 |
|
Index of ear weight |
1.00 |
2.10 |
1.92 |
2.01 |
|
Weight of lymph nodes |
M (g) |
0.0152 |
0.0168 |
0.0132 |
0.0137 |
SD |
16 |
9 |
30 |
17 |
|
Index of LN weight |
1.00 |
1.10 |
0.87 |
0.90 |
|
Number of lymph node cells |
M |
8,913,333 |
13,166,667 |
12,226,667 |
13,026,667 |
SD (% M) |
40 |
21 |
40 |
332 |
|
Stimulation index |
1.00 |
1.48 |
1.37 |
1.46 |
M = mean
SD = Standard Deviation
LN = Lymph nodes
Table 2: Calculation of the differentiation index
|
Aduct Urea-Sulfuric |
||
25% |
50% |
100% |
|
% max. LN cell count index-increase (max. = index 5) |
11.5 |
0.0 |
11.9 |
% max. ear thickness increase (max. = index 2) |
15.3 |
11.6 |
15.3 |
Differentiation index (DI) = (% max. LN cell count index increase) / (% max. ear thickness increase) |
0.75 |
0.00 |
0.78 |
The treatment with the test item in concentrations of 100%, 50% and 25% (v/v) did cause a transgression of the positive threshold value referring to the index of the increase of ear thickness. The index of the number of lymph node cells was also above the positive threshold value in the case of the test concentrations of 100% and 25%.
Differentiation indices lower than 1 were calculated for all three test concentrations indicating the irritation potential of the test item.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information non-specific (irritant) effect
- Conclusions:
- Based on the results of the study described, a non-specific (irritant) stimulation potential shall be attributed to the test item Aduct Urea-Sulfuric, in the tested concentrations of 25%, 50% and 100%.
- Executive summary:
In a dermal sensitization study (OECD 429, GLP) with aduct urea-sulfuric (uronium hydrogen sulphate) in acetone/olive oil (4:1 v/v), young NMRI mices (6 females per dose) were tested using the method of LLNA (IMDS test) at concentrations of 25, 50 and 100% (v/v).
In contrast to the information known on the substance (i.e. no irritation by skin contact in the rabbit, no irritation observed in the acute oral and dermal test) a severe irritant effect of the test item Aduct urea-sulfuric was revealed.
The treatment with the test item in concentrations of 100%, 50% and 25% (v/v) did cause a transgression of the positive threshold value referring to the index of the increase of ear thickness. The index of the number of lymph node cells was also above the positive threshold value in the case of the test concentrations of 100% and 25%.
Differentiation indices lower than 1 were calculated for all three test concentrations indicating the irritation potential of the test item.
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