Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-825-2 | CAS number: -
- 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 2013-05-22 to 2013-07-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of 12-hydroxyoctadecanoic acid with ethane-1,2-diamine and hexane-1,6-diamine and 1,3-phenylenedimethanamine
- EC Number:
- 700-825-2
- Molecular formula:
- Not applicable (UVCB substance).
- IUPAC Name:
- Reaction products of 12-hydroxyoctadecanoic acid with ethane-1,2-diamine and hexane-1,6-diamine and 1,3-phenylenedimethanamine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: the males had a mean body weight of 401 g (range: 391 g to 409 g) and the females had a mean body weight of 192 g (range: 182 g to 201 g)
- Fasting period before study: no
- Housing: the animals were housed by five from the same sex and group in polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 11 June 2013 to 28 June 2013.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The quantity of test item applied to each animal was adjusted according to the body weight recorded on the day of dose application.
- Constant volume: no - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- Ten Sprague-Dawley rats (five males and five nulliparous and non pregnant females).
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- No clinical signs were observed in any animals.
- Body weight:
- The mean body weight gain was unaffected by the test item treatment.
- Gross pathology:
- There were no macroscopic findings at necropsy.
- Other findings:
- On the application site, 4/5 females showed a very slight to well defined erythema on day 3 or from day 3 up to day 4 or 6, associated with dryness of the skin from day 3 or 5 up to day 6 or 7. In one of these four females, scabs were also observed from day 3 to day 5. Moreover, 3/5 males presented a very slight erythema on the application site on day 3 or days 3 to 4. These local reactions were considered to be related to the test substance.
No cutaneous reactions were noted in other animals.
Any other information on results incl. tables
Table 7.2.3/1: Mean body weight changes (g) in treated animals during the observation period compared to laboratory historical control data
Sex |
Female |
Male |
||
Group |
Laboratory Historical control data |
1 |
Laboratory Historical control data |
2 |
Dose-level (mg/kg bw) |
0 |
2000 |
0 |
2000 |
Body weight (mean (± SD)) |
||||
. Day 1 |
236 (± 8.9) |
192 (± 7.2) |
362 (± 12.0) |
401 (± 6.8) |
. Day 8 |
253 (± 12.0) |
223 (± 9.9) |
394 (± 15.3) |
435 (± 11.7) |
. Day 15 |
273 (± 16.3) |
247 (± 9.5) |
441 (± 21.5) |
474 (± 16.7) |
Body weight change (mean (± SD)) |
||||
. Days 1-8 |
+17 (± 11.0) |
+31 (± 7.9) |
+32 (± 9.1) |
+34 (± 7.9) |
. Days 8-15 |
+20 (± 7.1) |
+24 (± 6.5) |
+47 (± 7.5) |
+39 (± 5.1) |
. Days 1-15 |
+37 (± 16.3) |
+55 (± 6.7) |
+79 (± 15.6) |
+73 (± 12.0) |
SD: standard deviations.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of the test substance was higher than 2000 mg/kg bw in rats.
Therefore, the substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures. - Executive summary:
The substance was tested for acute dermal toxicity according to OECD 402 guideline and in compliance with Good Laboratory Practices.
The test item was applied in its original form to the skin of five female then five male Sprague‑Dawley rats at the dose-level of 2000 mg/kg bw. The application site was covered by a semi‑occlusive dressing for 24 hours.
Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded the day before treatment, then on days 1, 8 and 15.
On completion of the observation period, the animals were sacrificed and then submitted to a macroscopic post-mortem examination.
No unscheduled deaths occurred during the study and no clinical signs were observed in any animals.
Local reactions such as erythema, dryness of the skin and scabs were transiently noted in 7 out 10 animals given 2000 mg/kg bw. These were considered to be treatment- related.
When compared to historical control data, the mean body weight gain was considered to be unaffected by the test item treatment in males and females. At necropsy, there were no macroscopic findings related to the test item administration.
The acute dermal LD50 was found greater than 2000 mg/kg bw.
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.