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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2012-11-02 to 2012-12-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: CEGAV, Argenvilliers, France
- Age/weight at study initiation: at the beginning of the study, the animals were 2 to 4 months old and had a mean body weight of 3850 g (range: 3695 g to 3975 g)
- Fasting period before study: no
- Housing: the animals were individually housed in noryl cages
- Diet: 110 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): 18 ± 3°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: 27 November 2012 to 07 December 2012.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g/flank. - Duration of treatment / exposure:
- 3 min, 1 h, 4 h.
- Observation period:
- 1, 24, 48 and 72 h after removal of the dressing and if relevant, daily until reversibility of reactions.
- Number of animals:
- 3 males.
- Details on study design:
- TEST SITE
- Area of exposure: Right and left anterior and/or posterior flanks of the animals
- % coverage: 6 cm2
- Type of wrap if used: gauze pad held in place by a non-irritation semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing:using a moistened cotton pad
- Time after start of exposure: at removal of each dressing (see Duration of exposure)
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- : 4-hour exposure
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- : 4-hour exposure
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- : 4-hour exposure
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- : 4-hour exposure
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- : 4-hour exposure
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- : 4-hour exposure
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- After a 3-minute and a 1-hour exposures, a very slight erythema (grade 1) was observed from day 1 to day 4 in the treated animal .
After a 4-hour exposure, a well defined erythema (grade 2) was noted in one animal and a slight erythema (grade 1) was noted in the two others one hour after patch removal. At the 24-hour reading, a slight erythema was still present in one animal but cleared at the 72-hour reading.
Any other information on results incl. tables
Table 7.3.1/1 Cutaneous reactions after a 4 -hour exposure
Rabbit number |
Dermal irritation |
SCORES |
Mean irritation score (1) |
|||
1h |
24h |
48h |
72h |
|||
D1 |
D2 |
D3 |
D4 |
|||
A30281 |
Erythema |
2 |
1 |
1 |
0 |
0.7 |
Edema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
|
A30282 |
Erythema |
1 |
0 |
0 |
0 |
0.0 |
Edema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
|
A30283 |
Erythema |
1 |
0 |
0 |
0 |
0.0 |
Edema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
(1) mean of scores on days 2,3 and 4
h = hour
D= day
* = none
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 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 potential of the test item to induce skin irritation was assessed in 3 rabbits according to OECD Guideline 404 in compliance with Good Laboratory Practices.
The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single New Zealand White rabbit. After the 4-hour application, since the mean value from grading at 24, 48 and 72 hours after patch removal was < 2.3 for erythema or for edema, the test item was applied on the skin of two other animals for 4 hours.
A quantity of 0.5 g/flank was applied to a skin area of approximately 6 cm2under a semi-occlusive dressing for 4 hours. Skin reactions were observed 1, 24, 48, 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal. Each animal was observed once a day for mortality and clinical signs. Body weight was recorded at the beginning and the end of the observation period. On completion of the observation period, the animals were used subsequently for the evaluation of the ocular irritation potential of the same test item.
No unscheduled deaths occurred during the study and no clinical signs indicative of systemic toxicity were noted in any animals.The body weight of the animals was unaffected by the test item treatment.
After a 4-hour exposure, a well defined erythema (grade 2) was noted in one animal and a slight erythema (grade 1) was noted in the two others one hour after patch removal. At the 24-hour reading, a slight erythema was still present in one animal but cleared at the 72-hour reading.
The mean scores calculated for each animal over 24, 48 and 72 hours were 0.7, 0.0, 0.0 for erythema and 0.0, 0.0; 0.0 for oedema.
It was concluded that the test item was slightly irritant when applied topically to rabbits.
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