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EC number: 441-100-8 | CAS number: 351197-46-1
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Jan - 04 Mar 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- incl certificate of RCC Ltd, Itingen from Swiss Federal Office of Public Health
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 441-100-8
- EC Name:
- -
- Cas Number:
- 351197-46-1
- Molecular formula:
- Hill formula: C24 H48 N4 O6 CAS formula: C24 H48 O6 N4
- IUPAC Name:
- 2-[2-(dimethylamino)ethoxy]ethyl N-{[1,3,3-trimethyl-5-(9-methyl-2-oxo-3,6-dioxa-1,9-diazadecan-1-yl)cyclohexyl]methyl}carbamate
- Reference substance name:
- Carbamic acid, [[5-[[[2-[2- (dimethylamino)ethoxy]ethoxy]carbonyl]amino]-1,3,3- trimethylcyclohexyl]methyl]-,2-[2- (dimethylamino)ethoxy]ethyl ester
- IUPAC Name:
- Carbamic acid, [[5-[[[2-[2- (dimethylamino)ethoxy]ethoxy]carbonyl]amino]-1,3,3- trimethylcyclohexyl]methyl]-,2-[2- (dimethylamino)ethoxy]ethyl ester
- Details on test material:
- - Name of test material (as cited in study report): UAX-1179
- Physical state / appearance: pale, amber liquid
- Analytical purity: >99% proprietary tertiary amines
- Lot/batch No.: M. 17-08.01
- Expiration date of the lot/batch:19-Sep-2003
- Stability of test item dilution: Stable in the purified water for at least 7 days (determined at RCC Ltd, Environmental Chemistry & Pharmanalytics Division, under RCC study number 838563). Stable in FCA/NaCI 0.9 % for at least 2 hours.
- Storage condition of test material: In the original container, at room temperature (range of 20 +/- 3 °C), away from direct sunlight, heat and moisture. Stored under dry air (nitrogen).
- Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality guinea pigs (Himalayan spotted)
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wolferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation:3 - 6 weeks
- Weight at study initiation: Pretest group at pretest start: 386 - 411g, control and test group at beginning of acclimatization period: 409 - 445 g
- Housing: Individually in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418, batch nos. 93/01 and 116/01, guinea pig breeding / maintenance diet, containing Vitamin C (Provimi Kliba AG, CH-4303 Kaiseraugst), ad libitum.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: one week (no acclimatization for the animals of the pretest)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12
- Music was played during the daytime light period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- purified water (deionised water)
- Concentration / amount:
- Concentration of test material and vehicle used at intradermal induction:
Intradermal injection (0.1 mL/site)
a) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
b) Test item at 10% in purified water.
c) Test item at 10% in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Epidermal applications:
Test item 75% in purified water used for epidermal induction.
Concentration of test material and vehicle used for each challenge: 75% in purified water, 0.2 mL
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- purified water (deionised water)
- Concentration / amount:
- Concentration of test material and vehicle used at intradermal induction:
Intradermal injection (0.1 mL/site)
a) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
b) Test item at 10% in purified water.
c) Test item at 10% in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
Epidermal applications:
Test item 75% in purified water used for epidermal induction.
Concentration of test material and vehicle used for each challenge: 75% in purified water, 0.2 mL
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS: intradermal (10, 15 and 25% were tested : the concentration selected for the main study was 10% with discrete or patchy erythema) and epidermal pretest (15 - 75% were tested, no irritation up to 75%, technically, 75% test item concentration was the highest which could be applied to the skin to ensure optimal skin contact)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (see any other information on materials and methods)
- Test groups: FCA/NaCl or Test item 10% in purified water or in 1:1 FCA/NaCl [intradermal]; 75% in purified water after 10% SLS [epidermal] (see any other information on materials and methods)
- Control group: vehicle and or auxiliary compounds, 10% SLS before epidermal induction
- Site: dorsal skin
- Frequency of applications: 2, first intradermal on day 1 , second epidermal on the test day 8
- Concentrations: 10% intradermal (0.1 mL/site), 75% (0.3 mL) epidermal; see any other information on materials and methods
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Test groups: Test item 75% in purified water and one patch with water only (after 10% SLS)
- Control group: 75% in purified water and one patch with water only (after 10% SLS)
- Site: left flank for test item, right flank for control (purified water)
- Concentrations: 0.2 mL
- Evaluation (hr after challenge):24 h and 48h after removal of the bandage - Challenge controls:
- 75% in purified water (0.2 mL)
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole (performed from 14 May - 21 Jun 2001)
Results and discussion
- Positive control results:
- For validation of sensitivity of the GPMT test / test system used a study was performed with 15 (10 test and 5 control) male albino guinea pigs according to OECD 406. 2-Mercaptobenzothiazole was selected as positive control.
No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred. All 10 test animals showed discrete/patchy to intense erythema and swelling at the 24- and 48-hour reading after the challenge treatment with 2-MERCAPTOBENZOTHIAZOLE at 0.5 % (w/w) in mineral oil. No skin effect was observed in the control group.
Based on the mentioned findings in this adjuvant sensitization test the positive control 2-Mercaptobenzothiazole is a skin senitizer in guinea pigs.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- one animal of the test group was found dead on test day 1 (after intradermal induction)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 9.0. Total no. in groups: 9.0. Clinical observations: one animal of the test group was found dead on test day 1 (after intradermal induction).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: right flank (challenge control) of test group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: right flank (challenge control) of test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 9.0. Total no. in groups: 9.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: right flank (challenge control) of test group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: right flank (challenge control) of test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- one animal of the control group was found dead on test day 11 (induction phase)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: one animal of the control group was found dead on test day 11 (induction phase).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: right flank (challenge control) of negative control group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: right flank (challenge control) of negative control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: right flank (challenge control) of negative control group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: right flank (challenge control) of negative control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 4.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 75 %
Signs of irritation during induction:
The expected and common findings were observed in the control and test
group after the different applications using FCA intradermally. These
findings consisted of erythema, oedema, necrotizing dermatitis,
encrustation and exfoliation of encrustation.
Ventral recumbency and tremor were observed in 4 test animals
approximately 3 hours after the intradermal induction application.
The 75% concentration of the test item used for the challenge application was non-irritant and was the maximum concentration attainable.
The animals of the test and
control groups were all pretreated with 10% SLS approx. 21 hours before
the epidermal induction. After the epidermal induction application,
discrete/patchy to moderate/confluent erythema in the test (all animals)
and control (2 animals) group was observed.
Evidence of sensitisation of each challenge concentration: Concentration
75%: 9/9 (100%) of the animals showed sensitisation. Discrete/patchy to
moderate/confluent erythema were observed in all animals at the 24- and
48-hour reading after treatment with the test item at 75% in purified
water. No skin reactions were observed in the animals when treated with
purified water only.
Other observations:
One animal of the control group was found dead on test day 11 just prior
to the 24 -hour reading in the epidermal induction phase and one animal
of the test group was found dead on test day 1 after the intradermal
induction.No macroscopic findings were noted. The cause of death
could not be established.
The animal of the test group found dead on day 1 showed a loss of
body weight (8%) during the acclimatization period. The body weight of
the other animals was within the range commonly recorded for animals of
this strain and age.
Table 1: Test group; Skin response after the challenge application of UAX-1179, 75% in purified water (left flank) and application of purified water (right flank)
|
Left flank |
Right flank |
||
Male animals |
Reaction readings after removal of bandage |
|||
Animal No. |
24 hours |
48 hours |
24 hours |
48 hours |
302 |
2 |
2 |
0 |
0 |
303 |
1 |
1 |
0 |
0 |
304 |
2 |
2 |
0 |
0 |
305 |
2 |
2 |
0 |
0 |
306 |
1 |
1 |
0 |
0 |
307 |
2 |
2 |
0 |
0 |
308 |
2 |
2 |
0 |
0 |
309 |
2 |
2 |
0 |
0 |
310 |
1 |
1 |
0 |
0 |
311 |
exitus |
|
exitus |
|
Table 2: Positive control; Skin response after the challenge application of 2 -Mercaptobenzothiazole, 0.5% in mineral oil (left flank) and mineral oil (right flank)
|
Left flank |
Right flank |
||
Male animals |
Reaction readings after removal of bandage |
|||
Animal No. |
24 hours |
48 hours |
24 hours |
48 hours |
44 |
1 |
2 |
0 |
0 |
45 |
2 |
2 |
0 |
0 |
46 |
2 |
2 |
0 |
0 |
47 |
1 |
1 |
0 |
0 |
48 |
2 |
2 |
0 |
0 |
49 |
3 |
3 |
0 |
0 |
50 |
3 |
3 |
0 |
0 |
51 |
2 |
2 |
0 |
0 |
52 |
1 |
2 |
0 |
0 |
53 |
2 |
3 |
0 |
0 |
Table 3: Negative control; Skin response after the challenge application of UAX-1179, 75% in purified water (left flank) and purified water (right flank)
|
Left flank |
Right flank |
||
Male animals |
Reaction readings after removal of bandage |
|||
Animal No. |
24 hours |
48 hours |
24 hours |
48 hours |
297 |
0 |
0 |
0 |
0 |
298 |
0 |
0 |
0 |
0 |
299 |
0 |
0 |
0 |
0 |
300 |
exitus |
|
exitus |
|
301 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- UAX-1179 is considered to be a skin sensitizer.
- Executive summary:
The cutaneous allergenic potential of UAX-1179 was investigated by the GPMT. The study was performed in 15 male albino guinea pigs in accordance with OECD Guideline No. 406. Discrete/patchy to moderate/confluent erythema were observed in all animals at the 24- and 48-hour reading after treatment with the test item at 75% in purified water. No skin effect was observed in the control group. (One animal of the control group and one animal of the test group were found dead during the study. The cause of death could not be established.) Based on the findings of this adjuvant sensitization test UAX-1179 is considered to be a skin sensitizer.
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