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EC number: 236-526-4 | CAS number: 13419-67-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 06, 1999 to December 08, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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:
- Ammonium 2-mercaptopropionate
- EC Number:
- 236-526-4
- EC Name:
- Ammonium 2-mercaptopropionate
- Cas Number:
- 13419-67-5
- Molecular formula:
- C3H9NO2S
- IUPAC Name:
- ammonium 2-sulfanylpropanoate
- Test material form:
- liquid
- Details on test material:
- colourless
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White rabbits supplied by David Percival Ltd, Maston, Sandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.58 to 2.87 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 17 to 23 °C and 30 to 70 % respectively. Occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- Test performance:
On the day before the test each rabbit was dipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 mL of the test substance was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.
Observations:
Four hours after application the corset and patches were removed from each animal and any residual test substance removed by gentle swabbing with cotton wool soaked in 74 % Industrial Methylated Spirits.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J H, (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.
Any other skin reactions, if present, were also recorded. Additional observations were made on days 7 and 14 to assess the reversibility of skin reactions.
Interpretation of results:
Calculation of primary irritation index and grading of the irritancy potential using the Draize scheme:
The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test substance. The test substance was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity":
Primary irritation index:
0 (Non-irritant)
> 0 to 2 (Mild irritant)
> 2 to 5 (Moderate irritant)
> 5 to 8 (Severe irritant)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of three
- Time point:
- 14 d
- Score:
- 4.2
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- - Well-defined erythema was noted at all treated skin sites 1-hour after patch removal and at the 24, 48 and 72-hour observations. Very slight erythema was noted at two treated skin sites at the 7-day observation.
- Moderate oedema was noted at one treated skin site with slight oedema at two treated skin sites 1-hour after patch removal and at the 24-hour observation. Slight oedema was noted at all treated skin sites at the 48 and 72-hour observations. Very slight oedema was noted at two treated skin sites at the 7-day observation.
- Scattered areas of blanching of the skin were noted at all treated skin sites with scattered haemorrhage of the dermal capillaries also noted at two treated skin sites 1-hour after patch removal.
- Light brown discolouration of the epidermis was noted at all treated skin sites at the 24-hour observation. Light brown discolouration of the epidermis, loss of skin flexibility and/or loss of skin elasticity were noted at all treated skin sites at 48 and 72-hour observations. Crust formation was noted at all treated skin sites at the 7-day observation. Reduced regrowth of fur was noted at all treated skin sites with glossy skin also noted at one treated skin site at the 14-day observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance produced a primary irritation index of 4.2.
- Executive summary:
A study was conducted to determine the irritancy potential of the test substance to the skin of the New Zealand White rabbit according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. A single 4 h, semi-occluded application of the test substance to the intact skin of three rabbits produced well-defined erythema and slight to moderate oedema. Blanching of the skin, haemorrhage of the dermal capillaries, light brown discolouration of the epidermis, loss of skin elasticity, loss of skin flexibility, crust formation, reduced regrowth of fur and glossy skin were also noted. Under the study conditions, the test substance produced a primary irritation index of 4.2 (Sanders, 2000).
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