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EC number: 215-268-6 | CAS number: 1317-37-9
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, therefore it is considered relevant, reliable and adequate for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24 april 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Iron sulphide
- EC Number:
- 215-268-6
- EC Name:
- Iron sulphide
- Cas Number:
- 1317-37-9
- Molecular formula:
- FeS
- IUPAC Name:
- sulfanylideneiron
- 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: Toxicology, Department of Safety Assessment, Advinus Therapeutics Limited, Bangalore 560 058, India
- Age at treatment: 6-7 months
- Weight at treatment: 2.83 – 2.94 kg
- Fasting period before study: Not provided
- Housing: Individually in rabbit cages (approx. size L 65 x B 65 x H 45 cm) with noryl shallow cage body and facilities for pelleted food (Stainless steel feed hopper: changed at least 1x/week). The litter collection tray (noryl waste tray) will be changed daily (except on Sundays).
- Diet (e.g. ad libitum): Rabbit feed manufactured by Pranav agro Industries Ltd., Sangli, Maharashtra, India, ad libitum.
- Water (e.g. ad libitum): 750 mL makrolon bottle fitted with stainless steel sipper tube (changed at least 1x/week), deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier manufactured by Eureka Forbes Ltd., Mumbai 400 001, India
- Acclimation period: One rabbit (RB9615) was acclimatized for 5 days while the other two (RB9616 and RB9617) rabbits were acclimatized for 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 65-67%
- Air changes (per hr): 12-15/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: July 19, 2012 To: July 28, 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: de-ionised water
- Controls:
- other:
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 mL of
de-ionised water - Duration of treatment / exposure:
- 4 hours
- Observation period:
- At 1, 24, 48, 72 hours, 7 and 14 days post removal of test patch.
If reversibility is seen at 72 hours, 7 days or before 14 days, the experiment is terminated. - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: left side of the dorsolateral trunk
- % coverage: 6 cm2
- Type of wrap if used: cotton gauze (±6 cm : 2 x3 cm -6 ply) secured by an adhesive tape (‘Johnson –plast’ USP manufactured by Johnson & Johnson Ltd., Mumbai, India) and a crepe bandage around the torso
REMOVAL OF TEST SUBSTANCE
- Washing (if done): thoroughly with de-ionised water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the numerical scoring system of Draize et al. (1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Table 1. Individual Skin Reaction Scores
Rabbit No. |
Sex |
Washing after (hours) |
observations for skin reactions (post removal of the test patch) |
Erythema score |
Edema Score |
Total score |
|||
C |
T |
C |
T |
C |
T |
||||
RB9615* |
M |
4 |
1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
RB9616 |
M |
4 |
1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
RB9617 |
M |
4 |
1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
M: Male; C: Control patch; T: Treatment patch; 0: No Erythema/No Edema
* : The responses (skin reactions) were assessed immediately after the removal of the test patches at 3 minutes, 1 hour and 4 hours after application and it indicated that the test item was not irritating or corrosive.
Table 2. Mean Skin Reaction Scores
Observation (post removal of the test patch in)
|
Erythema Score |
Edema Score |
Total Mean Score |
|||
C |
T |
C |
T |
C |
T |
|
1 hour
|
0 |
0 |
0 |
0 |
0 |
0 |
24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
C: Control patch; T: Treatment patch; 0: No Erythema/No Edema
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, the test item, Tribotecc®-Ferrostar is “Non-irritant” to the skin of New Zealand White Rabbits under the testing conditions adopted as per Draize’s Classification Scheme.
- Executive summary:
The acute dermal irritation/corrosion study in New Zealand White Rabbits was conducted to evaluate the skin irritation potential of iron sulfide (Tribotecc ®-Ferrostar). A quantity of 0.5 g of the test item was made into paste by adding 0.2 mL of de-ionised water on a cotton gauze of 6 cm2 applied to the prepared area of skin under occlusive dressing. After 4 hours contact period, the treated area was washed with de-ionised water. The study was conducted in a stepwise manner (i.e., one rabbit was dosed, followed by two additional rabbits). The degree of irritation was evaluated and scored by CLP classification method at 1, 24, 48 and 72 hours post removal of the test patch. The total mean score of skin reaction was ‘0’ at all the observation periods, indicating that the test item did not cause dermal irritation to rabbits. There were no toxic signs, pre-terminal deaths and no skin reactions observed. There were no abnormalities detected at necropsy.
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