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EC number: 937-237-2 | CAS number: 1370006-50-0
- 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:
- 2007-10-31 to 2007-11-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
- Cas Number:
- 1370006-50-0
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 weeks
- Weight at study initiation:
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
Wood blocks (Harlan Laboratories Ltd., Füllinsdorf) and haysticks 4642 (batch no. 08/07, Provimi Kliba AG / Switzerland) were provided for gnawing.
- Diet: ad libitum, pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch no. 52/07) provided by Provimi Kliba AG, 4303 Kaiseraugst /
Switzerland.
- Water: ad libitum, municipal water
- Acclimation period: 4-6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod: 12 hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- purified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL test substance was weighed as delivered by the Sponsor and then moistened with approximately 0.5 mL of purified water
before application.
- pH: 6.44 (1 % solution) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 animals, 1 male, 2 females
- Details on study design:
- PRE-EXPERIMENTAL PROCEDURE
Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin
of the animals was examined one day before treatment, and regrown fur of all animals was clipped again.
ADMINISTRATION OF THE TEST ARTICLE
On the day of treatment, 0.5 mL of test substance was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The application sites were observed for erythema, edema and other dermal findings approximately 1, 24, 48 and 72 hours after patch removal and on study days 7, 10 and 14.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004.
Grading of skin reaction
Erythema and Eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) or eschar formation
(injuries in depth preventing erythema reading) 4
Oedema formation
No oedema 0
Vera slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (edges raised approximately 1mm) 3
Severe oedema (raised more then 1mm and
extending beyond the are of exposure) 4
Mortality / Viability: the rabbits were observed daily from acclimatization of the animals to the termination of test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: scaling present
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: scaling present
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: scaling present
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: scaling present
- Irritant / corrosive response data:
- CLINICAL SKIN OBSERVATIONS
One hour after removal of the dressing a well-defined erythema was observed in all animals which progressed into moderate to severe and persisted as very slight up to 10 or 14 days after treatment. A very slight to moderate oedema was recorded in all animals from the 1-hour up to the 72-hour reading or up to 10 days after treatment. Scaling was present in all animals 7 to 14 days after removal of the application patch.
No alterations and no corrosive effects were observed on the treated skin.
REVERSIBILITY
With the exception of scaling in all three animals and a very slight erythema in the male, these effects were reversible and were no longer evident 14 days after treatment. - Other effects:
- TOXIC EFFECTS OTHER THAN SKIN IRRITATION
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Body weights: the body weights of all rabbits were considered to be within the normal range of variability.
- No necropsy was performed on the animals sacrificed at termination of observation.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time
Score at time point |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
1 hour |
2/2/2 |
3/2/2 |
24 hours |
3/3/3 |
3/3/2 |
48 hours |
3/3/3 |
2/2/2 |
72 hours |
3/3/3 |
2/2/2 |
7 days |
1/1/1 |
1/0/1 * |
10 days |
1/1/1 |
1/0/1 * |
14 days |
1/0/0 |
0/0/0 * |
* = scaling present
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Judgment is based on erythema/eschar and edema calculated as mean scores for each animal following grading at 24, 48 and 72 hours after removal of the test material, in consideration of reversibility. The following mean scores were calculated for partially unsaturated IQAC, DMS quaternised (no solvent): erythema 3 and edema 2.33/2.33/2. Edema was fully reversible within 14 days in all animals, whereas scaling was still present in all animals at study termination (day 14). Erythema was not fully reversible at study day 14 in one animal.
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 (Apr. 24, 2002), three young adult New Zealand White rabbits were dermally exposed to 0.5 mL of partially unsaturated IQAC, DMS quaternised (100 % a.i.) moistened with 0.5 mL purified water for 4 hours under semi-occlusive dressing. Animals then were observed for 14 days. The skin reaction was scored according to OECD Guideline 404.
One hour after removal of the dressing a well-defined erythema was observed in all animals which progressed into moderate to severe and persisted as very slight up to 10 or 14 days after treatment. A very slight to moderate oedema was recorded in all animals from the 1-hour up to the 72-hour reading or up to 10 days after treatment. Scaling was present in all animals 7 to 14 days after removal of the application patch. No alterations and no corrosive effects were observed on the treated skin.
In this study, partially unsaturated IQAC, DMS quaternised is a dermal irritant. The test substance is irritating to the skin based on results of the topical semi-occlusive application in rabbits.
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