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EC number: 239-555-0 | CAS number: 15520-05-5
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-12-07 to 2016-04-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,2'-(octylimino)bisethanol
- EC Number:
- 239-555-0
- EC Name:
- 2,2'-(octylimino)bisethanol
- Cas Number:
- 15520-05-5
- Molecular formula:
- C12H27NO2
- IUPAC Name:
- 2-[(2-hydroxyethyl)(octyl)amino]ethan-1-ol
- Test material form:
- other: liquid
- Details on test material:
- Name: Genamin 3920
CAS No.: 15520-05-5
Molecular Weight of Base Form: 217.3483
Chemical Name: 2,2’-(Octylimino)bisethanol
Physical State at RT: liquid
Colour: clear
pH: 11.6 (23 °C, water:ethanol 1:1)
Storage Conditions: 2 – 8 °C, protected from light
Safety Precautions: The routine hygienic procedures are sufficient to assure personnel health and safety.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 02102150820)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 0446 )
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Preparation of the Animals:
The animals were marked for individual identification by tail painting.
Approximately 25 hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid
abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals. Only healthy animals were used.
Application:
The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and
non-irritating tape and was fixed with an additional dressing in a suitable manner. - Duration of exposure:
- The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period the residual test item was not
removed. - Doses:
- The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not required
- Details on study design:
- Observation period:
All animals were observed for 14 days after dosing
Weight Assessment:
The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
Clinical Examination:
careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given
during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions,
salivation, diarrhoea, lethargy, sleep and coma.
Pathology:
At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial;
lot no.: 250055; expiry date: 31/05/2018) at a dosage of 250-400 mg/kg bw. All animals were subjected to gross necropsy and examined
macroscopically for gross pathological changes. In absence of gross pathological changes no tissues were preserved for a possible histopathologicalevaluation.
Evaluation of Results:
Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by sex and dose level.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.
Necropsy findings were described.
With few exceptions, data were captured using the validated departmental computerised system E WorkBook (version 9.4.0, ID Business Solutions Ltd.) - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the
results is not regarded as necessary.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- other: No treatment-related effects were observed.
- Gross pathology:
- On the skin and in the subcutis either scab or scab and one or more red or dark foci were observed in all animals.
- Other findings:
- Erythema up to grade 2 and oedema up to grade 2 were observed in all animals. Either necrosis or eschar or both were observed in all animals.
The signs of irritation were not reversible within the observation period.
Any other information on results incl. tables
Animal No. |
Dose (mg/kg bw) |
Timepoint |
Observations |
Comment |
|||||
21 |
2000 |
(0min – 240min) |
Nsf |
- |
|||||
21 |
2000 |
(2d – 15d) |
Nsf |
Local findings |
|||||
22 |
2000 |
(0min – 240min) |
Nsf |
- |
|||||
22 |
2000 |
(2d- 5d) |
Nsf |
Local findings |
|||||
22 |
2000 |
(6d – 12d) |
Nsf |
- |
|||||
22 |
2000 |
(13d – 15d) |
Nsf |
Local findings |
|||||
23 |
2000 |
(0min – 6d) |
Nsf |
- |
|||||
23 |
2000 |
(7d) |
Nsf |
Local findings |
|||||
23 |
2000 |
(8d – 12d) |
Nsf |
- |
|||||
23 |
2000 |
(13d – 15d) |
Nsf |
Local findings |
|||||
24 |
2000 |
(0min – 6d) |
Nsf |
- |
|||||
24 |
2000 |
(7d – 15d) |
Nsf |
Local findings |
|||||
25 |
2000 |
(0min – 240min) |
Nsf |
- |
|||||
25 |
2000 |
(2d – 15d) |
Nsf |
Local findings |
Animal No. |
Dose (mg/kg bw) |
Timepoint |
Observations |
Comment |
|||||
26 |
2000 |
(0min – 240min) |
Nsf |
- |
|||||
26 |
2000 |
(2d – 15d) |
Nsf |
Local findings |
|||||
27 |
2000 |
(0min- 12d) |
Nsf |
- |
|||||
27 |
2000 |
(13d – 15d) |
Nsf |
Local findings |
|||||
28 |
2000 |
(0min – 240min) |
Nsf |
- |
|||||
28 |
2000 |
(2d – 15d) |
Nsf |
Local findings |
|||||
29 |
2000 |
(0min – 240min) |
Nsf |
- |
|||||
29 |
2000 |
(2d – 15d) |
Nsf |
Local findings |
|||||
30 |
2000 |
(0min – 240 min) |
Nsf |
- |
|||||
30 |
2000 |
(2d – 15d) |
Nsf |
Local findings |
min = minute(s); h = hour(s); d = day(s), bw = body weight;nsf = no specific findings
Skin Irritation at Application Site – Individual Data – Males
Animal No. | Timepoint | Oedema/ | Local | Comment |
Erythema | Skin Findings | |||
21 | (2d – 5d) | 0/0 | Necrosis | Black focus at application site approx. 2cmx2cm |
21 | (6d – 8d) | 1/2 | Necrosis | Black focus approx. 3cmx4cm |
21 | (9d -12d) | 1/1 | Necrosis | Black focus approx. 3cmx4cm |
21 | (13d – 15d) | 0/1 | Necrosis | Eschar peeling off, black focus approx. ø 1cm |
22 | (2d) | 0/0 | Necrosis | Black focus at application site approx. 2cmx2cm |
22 | (3d – 4d) | 0/0 | Necrosis | Black focus at application site approx. ø 0.5cm |
22 | (5d) | 1/1 | Necrosis | Black focus at application site approx. ø 0.5cm |
22 | (6d) | 2/2 | Nsf | - |
22 | (7d) | 1/2 | Nsf | - |
22 | (8d – 12d) | 0/1 | Nsf | - |
22 | (13d - 14d) | 0/0 | Eschar | 3 foci ø 0.5cm |
22 | (15d) | 0/0 | Eschar | 2 foci ø 0.3cm |
23 | (2d – 4d) | 0/0 | Nsf | - |
23 | (5d) | 1/1 | Nsf | - |
23 | (6d) | 2/2 | Nsf | - |
23 | (7d) | 2/2 | Necrosis | Black focus approx. 1.5cmx1.5cm |
23 | (8d – 12d) | 0/1 | Nsf | - |
23 | (13d) | 0/0 | Eschar | 1 focus ø 0.5 cm |
23 | (14d – 15d) | 0/0 | Eschar | 1 focus ø 0.3 cm |
24 | (2d – 4d) | 0/0 | Nsf | - |
24 | (5d) | 1/1 | Nsf | - |
24 | (6d) | 2/2 | Nsf | - |
24 | (7d) | 2/2 | Necrosis | Black focus approx. 2cmx2cm |
24 | (8d) | 1/1 | Necrosis | Black focus approx. 1cmx1cm |
24 | (9d – 12d) | 0/1 | Necrosis | Black focus approx. 1cmx1cm |
24 | (13d) | 0/0 | Eschar | 1 focus ø 0.5cm |
24 | (14d – 15d) | 0/0 | Eschar | 1 focus ø 0.3cm |
25 | (2d) | 0/0 | Necrosis | Black focus at application site approx. 2cmx2cm |
25 | (3d – 4d) | 0/0 | Necrosis | Black focus at application site approx. 1cm |
25 | (5d) | 1/1 | Necrosis | Black focus at application site approx. 1cm |
25 | (6d) | 1/2 | Necrosis | Black focus approx. 1cmx0.5cm |
25 | (7d) | 1/2 | Necrosis | Black focus approx. 2cmx2cm |
25 | (8d) | 1/1 | Necrosis | Black focus approx. 1.5cmx1.5cm |
25 | (9d – 12d) | 0/1 | Necrosis | Black focus approx. 1.5cmx1.5cm |
25 | (13d – 15d) | 0/0 | Eschar | 2 foci ø 0.3cm |
Animal No. | Timepoint | Oedema/ | Local | Comment |
Erythema | Skin Findings | |||
26 | (2d – 4d) | 0/0 | Necrosis | Black focus at application site approx. 2cmx2cm |
26 | (5d) | 2/2 | Necrosis | Black focus at application site approx. 2cmx2cm |
26 | (6d – 12d) | 2/2 | Necrosis | Black focus approx. 3cmx4cm |
26 | (13d – 15d) | 0/1 | Necrosis | Black focus approx. 2cmx2cm, eschar peeling off |
27 | (2d – 3d) | 0/0 | nsf | - |
27 | (4d) | 0/2 | nsf | - |
27 | (5d) | 1/2 | nsf | - |
27 | (6d – 7d) | 2/2 | nsf | - |
27 | (8d – 12d) | 0/1 | nsf | - |
27 | (13d – 15d) | 0/0 | Eschar | 1 focus approx. ø 0.4cm |
28 | (2d – 4d) | 0/0 | Necrosis | Black focus at application site approx. 2cmx2cm |
28 | (5d) | 1/2 | Necrosis | Black focus at application site approx. 2cm.x2cm |
28 | (6d – 7d) | 2/2 | Necrosis | Black focus approx. 2cmx2cm |
28 | (8d – 12d) | 1/1 | Necrosis | Black focus approx. 2cmx2cm |
28 | (13d – 15d) | 0/1 | Necrosis | Black focus approx. 2cmx2cm |
29 | (2d – 3d) | 0/0 | Necrosis | Black focus at application site approx. 2cmx2cm |
29 | (4d) | 0/1 | Necrosis | Black focus at application site approx. 2cmx2cm |
29 | (5d) | 0/2 | Necrosis | Black focus at application site approx. 2cmx2cm |
29 | (6d) | 1/2 | Necrosis | Black focus approx. 2cmx2cm |
29 | (7d) | 1/2 | Necrosis | Black focus approx. 2.5cmx2.5cm |
29 | (8d) | 1/1 | Necrosis | Black focus approx. 2.5cmx2.5cm |
29 | (9d – 12d) | 0/1 | Necrosis | Black focus approx. 2.5cmx2.5cm |
29 | (13d) | 0/0 | Necrosis | Black focus approx. 2.5cmx2.5cm |
29 | (14d – 15d) | 0/0 | Eschar | Eschar peeling off, approx. ø 1cm |
30 | (2d – 4d) | 0/0 | Necrosis | Black focus at application site approx. 2cmx2cm |
30 | (5d – 6d) | 1/2 | Necrosis | Black focus at application site approx. 2cmx2cm |
30 | (7d) | 2/2 | Necrosis | Black focus approx. 2.5cmx2.5cm |
30 | (8d – 12d) | 1/1 | Necrosis | Black focus approx. 2.5cmx2.5cm |
30 | (13d – 14d) | 0/1 | Necrosis | Black focus approx. 1cmx1cm, eschar peeling off |
30 | (15d) | 0/0 | Eschar | Eschar peeling off, approx. ø 1cm |
E
= erythema; O = oedema; 0, 1, 2, 3, 4 = scoring system laid down in OECD
Guideline 404;
nsf
= no specific findings
Absolute Body Weights in g and Body Weight Gain in %
Test Group | Animal No. | Dose (mg/kg bw) | Body Weight (g) on Day | BW gain in Comparison to Day 1 (%) | ||
Day 1 | Day 8 | Day 15 | Day 15 | |||
Males | 21 | 2000 | 243 | 252 | 258 | 6 |
22 | 241 | 257 | 278 | 15 | ||
23 | 244 | 257 | 280 | 15 | ||
24 | 267 | 283 | 321 | 20 | ||
25 | 241 | 257 | 282 | 17 | ||
Females | 26 | 2000 | 231 | 227 | 212 | -8 |
27 | 232 | 228 | 235 | 1 | ||
28 | 225 | 221 | 227 | 1 | ||
29 | 230 | 237 | 243 | 6 | ||
30 | 220 | 218 | 225 | 2 |
bw = body weight
Macroscopic Findings - Individual Data - Males and Females
Test Group | Animal No. | Dose (mg/kg bw) | Organ | Macroscopic Findings |
Males | 21 | 2000 | Skin | Scab 1cm |
Subcutis | Focus red 1cm | |||
22 | 2000 | Skin | Scab 2cmx0.3cm | |
23 | 2000 | Skin | Scab 0.3cm | |
24 | 2000 | Skin | Scab 0.3cm | |
25 | 2000 | Skin | Scab 2cmx0.3cm | |
Females | 26 | 2000 | Skin | Scab 4cm |
Subcutis | Focus dark 1cm; | |||
focus red 3cm | ||||
27 | 2000 | Skin | Scab 0.4cm | |
Subcutis | Focus red 0.2cm | |||
28 | 2000 | Skin | Scab 4cm | |
Subcutis | Focus red 1cm | |||
29 | 2000 | Skin | Scab 1cm | |
Subcutis | Focus red 1cm | |||
30 | 2000 | Skin | Scab 1cm | |
Subcutis | Focus red 1cm |
nsf = no specific findings
LD50
Test Group | Dose (mg/kg bw) | Number of Animals | Number of Intercurrent Deaths | LD50Cut-Off (mg/kg bw) |
Males | 2000 | 5 | 0 | > 2000 |
Females | 2000 | 5 | 0 |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- severely irritating but no systemic toxicity
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item Genamin 3920 to rats at a dose of 2000 mg/kg body weight was
associated with no mortality and no signs of systemic toxicity but with signs of irritation/corrosion at the application site which were not fully
reversible within the observation period.
The dermal LD50 was determined to be > 2000 mg Genamin 3920 / kg body weight. - Executive summary:
Summary Results
LD50: > 2000 mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): no vehicle used
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402, EC 440/2008, Method B.3
Results
Test Group
Animal No.
Dose (mg/kg bw)
Number of Animals
Number of Intercurrent Deaths
Males
21 - 25
2000
5
0
Females
26 - 30
2000
5
0
bw = body weight
Signs of systemic toxicity related to dose level used, time of onset and duration:
No treatment-related effects were observed.
Effect on organs (related to dose level):
On the skin and in the subcutis either scab or scab and one or more red or dark foci were observed in all animals.
Signs of irritation:
Erythema up to grade 2 and oedema up to grade 2 were observed in all animals.Either necrosis or eschar or both were observed in all animals.
The signs of irritation were not reversible within the observation period.
Conclusion
Under the conditions of the present study, single dermal application of the test itemGenamin 3920to rats at a dose of 2000 mg/kg body weight was associated with no mortality and no signs of systemic toxicity but with signs of irritation/corrosion at the application site which were not fully reversible within the observation period.
The dermal LD50was determined to be > 2000 mgGenamin 3920/ kg body weight.
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