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EC number: 614-657-1 | CAS number: 68609-08-5
- 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:
- from 2007-10-03 to 2007-12-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 92/69/EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
- EC Number:
- 614-657-1
- Cas Number:
- 68609-08-5
- Molecular formula:
- C41H68N4O4
- IUPAC Name:
- Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. TOXI COOP Ltd. 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: Young adult rats
- Weight at study initiation: Male: 252 - 283 g; Female: 216 - 239 g
- Fasting period before study: None
- Housing: Individual caging (1 animal/cage); Type II polypropylene/polycarbonate
- Diet: Animals received ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany and tap water from the municipal supply, ad libitum.
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 -24 °C
- Humidity (%): 38 - 58 %
- Air changes (per hr): 8 - 12 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Test item was pulverized and moistened with water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 10 per cent of the total body surface
- % coverage: appr. 10
- Type of wrap if used: semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing: water at body temperature
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount applied: single dose of 2000 mg/kg bw
- For solids, paste formed: yes, with water - Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Males: 5; 2000 mg/kg bw;
Females: 5; 2000 mg/kg bw; - Control animals:
- no
- Details on study design:
- Observations: Animals were observed for a 14-day post-treatment period. Clinical examinations, body weight assessment and gross necropsy were conducted.
Clinical Examination: A careful individual clinical examination was made on the day of treatment 1 h and 5 h after the administration of the test item, and once each day for 14 days thereafter. Individual observations were performed on the skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern.
Weight Assessment: The body weight of each animal was recorded on day 0 (beginning of the experiment), on day 7 and on day 14 with a precision of 1 g.
Pathology: On day of the last clinical observation, all animals were exsanguinated under carbon dioxide anaesthesia and gross necropsy was performed. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All gross pathological changes were recorded for each animal on post mortem record sheets.
Evaluation of Results: The method used allows assigning an LD50 value, according to the OECD Guidelines for Testing of Chemicals, No. 402, and B.3. 92/69/EEC.
Individual animal data were provided and summarised in tabular form, showing for each dose group the number of animals used.
Clinical observations were noted individually and in summary tables.
Body weight changes were summarised in tabular form.
Necropsy findings were described and summarised in tabular form. - Statistics:
- No statistics performed
Results and discussion
- Preliminary study:
- No preliminary study was performed
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male Female
Dose level (mg/kg bw): 2000 2000
Number of animals treated: 5 5
Number of dead animals: 0 0 - Clinical signs:
- other: There were no clinical signs. The behaviour and physical condition of animals were considered to be normal. 2000 mg/kg bw of the test item caused slight to marked erythema (5/5 male, 5/5 female), erosion (1/5 female) and sloughing (3/5 male, 5/5 female) o
- Gross pathology:
- No macroscopic alterations due to the effects of the test item were found. Gross necropsy revealed pinprick-sized haemorrhages (5/5 male, 2/5 female) and reddish mottled colour (1/5 female) in the lungs due to the method of anaesthesia and exsanguinations, which are also observable in untreated animals after anaesthesia.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single 24-hour dermal administration of 2000 mg/kg bw of the test item, the test item caused erosion, erythema and sloughing on the treated skin, which recovered within 2 - 13 days. Mortalities were not observed, neither in male nor in female CRL:(WI)BR rats. The acute dermal LD50 value of the test item is greater than 2000 mg/kg bw in male and female CRL: (WI) BR rats.
- Executive summary:
The acute dermal toxicity study (Limit Test) with the test item was performed in compliance with OECD guideline No.: 402 and method B.3. 92/69/EEC. A limit test was carried out at 2000 mg/kg bw dose level. Five male and five female CRL:(WI)BR rats were treated with a dose of 2000 mg/kg bw. The test item was applied once in its original form by dermal route and held in contact with the skin for a 24-hour period. The observation period after patch removal continued for 14 days. Clinical observations were made one and five hours after the treatment, then once a day. Body weight was measured weekly. Gross necropsy was performed in all animals at the termination of the experiment.
Mortality
No mortality was observed in male and female animals up to the limit dose of 2000 mg/kg bw.
Clinical Observations
There were no clinical signs. The behaviour and physical condition of animals were considered to be normal. 2000 mg/kg bw of the test item caused slight to marked erythema (5/5 male, 5/5 female), erosion (1/5 female) and sloughing (3/5 male, 5/5 female) on the skin after 24-hour exposure. Skin became normal between days 2 and 10 in male animals and between days 8 and 13 in female animals.
Body Weight
The mean body weight and the body weight gain of the male and female animals were considered to be normal during the two-week observation period., similar to the expected values in untreated animals of the same age and strain.
The following table contains the body weight and body weight gain values of control animals of same age and strain.
Male animals:
Body weight (g)
Body weight gain (g)
Day 0
Day 7
Day 14
Day 0 - 7
Day 7 - 14
Day 0 - 14
Mean
264.5
316.6
366.4
52.0
49.8
101.9
Sd
15.0
14.1
15.1
4.9
7.6
8.7
n
21
21
21
21
21
21
Female animals:
Body weight (g)
Body weight gain (g)
Day 0
Day 7
Day 14
Day 0 - 7
Day 7 - 14
Day 0 - 14
Mean
226.7
242.7
251.3
16.0
8.7
24.7
Sd
6.8
7.3
10.2
7.8
5.8
11.1
n
23
23
23
23
23
23
Necropsy
No macroscopic alterations due to the effects of the test item were found. Gross necropsy revealed pinprick-sized haemorrhages (5/5 male, 2/5 female) and reddish mottled colour (1/5 female) in the lungs due to the method of anaesthesia and exsanguinations, which are also observable in untreated animals after anaesthesia.
Under the conditions of the present study, a single 24 -hour dermal administration of 2000 mg/kg bw of test item, the test item caused erosion, erythema and sloughing on the treated skin, which recovered within 2 - 13 days. Mortalities were not observed, neitehr in male nor in female CRL:(WI)BR rats. The acute dermal LD50 value of the test item is greater than 2000 mg/kg bw in male and female CRL:(WI) BR rats.
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