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EC number: 914-147-1 | 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:
- 28 June 2010 - Sept.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline (observed deviation was not considered to have compromised the validity of the results and study); adequate coherence between data, comments and conclusions.
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)
- Deviations:
- yes
- Remarks:
- temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan (up to 24°C)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- temperature recorded in the animal room was sometimes outside of the target ranges specified in the study plan (up to 24°C)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
- IUPAC Name:
- Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
- Details on test material:
- - Name of test material (as cited in study report): Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoediate
- Substance type: UVCB (substance of unknown or variable composition, complex reaction products or biological materials)
- Physical state: brown liquid
- Purity test date: 26 march 2009
- Lot/batch No.: T710/712
- Expiration date of the lot/batch: 20 September 2010
- Storage conditions of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Grimaud Frères Selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: on the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation:on the day of treatment, the animals had a mean body weight ± standard deviation of 2.7 ± 0.2 kg
- Housing: the animals were individually housed in Pajon cages (50 cm x 57 cm x 75 cm)
- Diet (e.g. ad libitum): free access to breeding pelleted diet “type 110”
- Water (e.g. ad libitum): tap water (filtered using a 0.22 µm filter) contained in bottles
- 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: From: 29 June 2010 To: 26 July 2010.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL of undiluted test item - Duration of treatment / exposure:
- 3 minutes, 1 hour, 4 hours.
- Observation period:
- For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then
daily until the reversibility of cutaneous reactions. - Number of animals:
- Three males.
- Details on study design:
- TEST SITE
- Area of exposure: anterior left flank (application for 3 minutes), anterior right flank (application of 1 hour), posterior right flank (application for
4 hours).
- % 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 (if done): any residual test item was wiped off by means of a moistened cotton pad
- Time after start of exposure: the test item was placed on a dry gauze pad, which was then applied to an area of the skin of approximately 6 cm2 of
the animals. The gauze pad was held in place by a non-irritation semi occlusive dressing and a restraining bandage.
For the 4-hour exposure, a dry gauze pad was applied to the opposite flank, which was acted as control.
After required period of contact with the skin, the dressings were removed.
SCORING SYSTEM:
Dermal irritation was evaluated for each animal according to the following scoring scale:
Erythema and eschar formation:
. no erythema 0
. very slight erythema (barely perceptible) 1
. well-defined erythema 2
. moderate to severe erythema 3
. severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Edema formation
. no edema 0
. very slight edema (barely perceptible) 1
. slight edema (edges of area well-defined by definite raising) 2
. moderate edema (raised approximately 1 millimeter) 3
. severe edema (raised more than 1 millimeter and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 8
- Remarks on result:
- other: Exposure of 3 minutes
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure of 3 minutes
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 8
- Remarks on result:
- other: Exposure of 1 hour
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure of 1 hour
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 9
- Remarks on result:
- other: Exposure of 4 hours. Individual scores are : 1.0 - 0.0 - 1.7
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure of 4 hours
- Irritant / corrosive response data:
- After a 3 minute exposure, a very slight erythema was observed from day 1 until day 7.
After a 1 hour exposure, a very slight to well-defined erythema was observed from day 1 to day 7
After a 4 hours exposure (three animals), a very slight erythema was observed on day 1 only in one animal, and from day 1 to day 4 in a second one. In the third treated animal, a well-defined erythema was observed from day 1 to 3, decreasing to a very slight erythema from day 4 to day 8. - Other effects:
- Dryness of the skin was also noted:
After a 3-minute exposure (animal No. 569), from day 5 to 7;
After a 1 hour exposure (animal No. 569) on days 6 and 7
After a 4-hour exposure, from day 2 to day 11 in 1/3 animal.
After a 1-hour exposure (animal No. 569)
A dryness of the skin was noted on days 6 and 7.
After a 4-hour exposure (three animals)
Dryness of the skin was also noted in this last animal, from day 2 to day 11.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information but not classified Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)
- Conclusions:
- Under the experimental conditions of this study, the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, (batch No. T710/712) was slightly irritant when applied topically to rabbits.
- Executive summary:
The objective of this study was to evaluate the potential of the test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, to induce skin irritation following a single topical application to rabbits according to OECD (No. 404, 24th April 2002) and Commission Regulation (EC) (No. 440/2008, B.4, 30 May 2008) guidelines.
The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
Methods
The test item, Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate, was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit.
Since the test item was not severely irritant or corrosive to the skin on this first animal, it was then applied for 4 hours simultaneously to two other animals.
The quantity of the test item administered was 0.5 mL. The test item was placed on a dry gauze pad, which was then applied to an area of the skin of approximately 6 cm2 of the animals. The gauze pad was held in place by a non-irritation semi-occlusive dressing and a restraining bandage. After required period of contact with the skin, the dressings were removed.
For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the reversibility of cutaneous reactions.
Body weight was recorded at the beginning and the end of the observation period. On completion of the observation period, the animals were sacrificed then discarded without macroscopic post‑mortem examination.
The mean values of the scores for erythema and edema were calculated for each animal.
Results
After a 3 -minute exposure (one animal)
A very slight erythema was observed from day 1 until day 7. Dryness of the skin was also noted from day 5 to 7.
After a 1 -hour exposure (one animal)
A very slight to well-defined erythema was observed from day 1 to day 7, associated with a dryness of the skin on days 6 and 7.
After a 4-hour exposure (three animals)
A very slight erythema was observed on day 1 only in one animal, and from day 1 to day 4 in a second one. In the third treated animal, a well-defined erythema was observed from day 1 to 3, decreasing to a very slight erythema from day 4 to day 8. Dryness of the skin was also noted in this last animal, from day 2 to day 11.
Mean scores over 24, 48 and 72 hours for each animal were 1.0, 0.0 and 1.7 for erythema and 0.0, 0.0 and 0.0 for edema.
Conclusion
Under the experimental conditions of this study, the test item Reaction mass of sodium sulfate, sodium amino-12-dodecanoate and sodium dodecanoedioate (batch No. T7110/712) was slightly irritant when applied topically to rabbits.
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