Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Annex to Commission Directive 2001/73/EC, 2004
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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: 2.60 – 2.92 kg
- 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) and drinking water (750 mL makrolon bottle fitted with sipper tube). The litter collection trays (noryl waste tray) were washed daily with water (except on Sundays). The water bottle and feed hopper were changed once a week.
- Diet (e.g. ad libitum): Rabbit feed manufactured by Pranav agro Industries Ltd, Sangli, Maharashtra, India was provided ad libitum.
- Water (e.g. ad libitum): 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 provided in Makrolon bottles with stainless steel sipper tubes, ad libitum.
- Acclimation period: One rabbit was acclimatized for 5 days while the other two rabbits were acclimatized for six days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C
- Humidity (%): 65-66%
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:August 8, 2012 To: August 17, 2012 (August 13,2012 to August 21,2012 ??)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (0.1g) - Duration of treatment / exposure:
- single application; the lids were held together gently for about one second to prevent loss of test item.
- Observation period (in vivo):
- Initial single animal: 96 hours (scores only recorded through 72 hours post instillation)
Confirmatory two rabbits: up to 72 hours post application
The eyes of each rabbit were examined at 1, 24, 48 and 72 hours post-instillation and scored. - Number of animals or in vitro replicates:
- 3 (Initial Test: single animal test; Confirmatory Test: two additional animals)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours contact period, the treated eye was irrigated with de-ionised water for one minute to remove the residual test item. Similarly, the control eye was also irrigated with de-ionised water.
- Time after start of exposure:24 hours
SCORING SYSTEM:
The grades of ocular reaction was assessed according to the numerical scoring system, as per 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. 48 to 49 (Table 1)) and Classification according to “Modified Version of the Kay J H and Calandra J C. (1962) System” (Table 2).
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Maximum total score possible = 110
Using the numerical data obtained, a modified version of the system described by Kay J H and Calandra J C. 1962., (J. Soc. Cosmet. Chem., 13:281-289) was used to classify the ocular irritancy potential of the test item. This is achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation is calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enables the classification of the eye irritancy potential of the test item.
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Redness score of 1 was observed in all the three rabbits at 1, 24 & 48 hours post instillation. Chemosis score of 1 was observed in 1 rabbit at 24 & 48 hours and in the other 2 rabbits at 24 hours post instillation. In one rabbit discharge score of 2 was observed at 1 hour and 24 hours and score of 1 at 48 hours, in the other two rabbits discharge score of 2 was observed 1 hour and score of 1 at 24 & 48 hours post instillation. There were no eye reactions observed at 72 hours post instillation. There were no corneal opacity and iris reactions.
Any other information on results incl. tables
Table 1. Individual Eye Irritation Scores
Rabbit No. |
Elapsed Time
|
CONJUNCTIVA |
IRIS |
CORNEA |
Total score (0-110) |
||||||
Redness (0-3) A |
Chemosis (0-4) B |
Discharge (0-3) C |
Tissue score (0-20) (A+B+C) x 2 |
Pupil (0-2) D |
Tissue score (0-10) Dx5 |
Opacity (0-4) E |
Area of opacity (1-4) F |
Tissue score (0-80) (E x F) x 5 |
|||
RB9630 |
1 hour |
1 |
0 |
2 |
6 |
0 |
0 |
0 |
NA |
0 |
6 |
24 hours |
1 |
1 |
1 |
6 |
0 |
0 |
0 |
NA |
0 |
6 |
|
48 hours |
1 |
1 |
1 |
6 |
0 |
0 |
0 |
NA |
0 |
6 |
|
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
NA |
0 |
0 |
|
Mean |
24-72 h |
0.66 |
0.66 |
0.66 |
|
0 |
|
0 |
|
|
|
RB9631 |
1 hour |
1 |
0 |
2 |
6 |
0 |
0 |
0 |
NA |
0 |
6 |
24 hours |
1 |
1 |
1 |
6 |
0 |
0 |
0 |
NA |
0 |
6 |
|
48 hours |
1 |
0 |
1 |
4 |
0 |
0 |
0 |
NA |
0 |
4 |
|
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
NA |
0 |
0 |
|
Mean |
24-72 h |
0.66 |
0.33 |
0.66 |
|
0 |
|
0 |
|
|
|
RB9632 |
1 hour |
1 |
0 |
2 |
6 |
0 |
0 |
0 |
NA |
0 |
6 |
24 hours |
1 |
1 |
2 |
8 |
0 |
0 |
0 |
NA |
0 |
8 |
|
48 hours |
1 |
0 |
1 |
4 |
0 |
0 |
0 |
NA |
0 |
4 |
|
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
NA |
0 |
0 |
|
Mean |
24-72 h |
0.66 |
0.33 |
1 |
|
0 |
|
0 |
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the highest total mean eye reaction score of “6.67” at 24 hours post instillation and together with the persistence of the reaction the test item Tribotecc® - Ferrostar is a “Mild Irritant” according to “Modified Version of the Kay J H and Calandra J C. (1962) System”.
Based on the results of the present study the test item Tribotecc® - Ferrostar however does not need to be classified as per Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. - Executive summary:
The acute eye irritation / corrosion study in New Zealand White rabbits was conducted to evaluate the eye irritation potential of iron sulfide (Tribotecc® - Ferrostar). On test day one, a quantity of 100 mg (0.1g) of test item was instilled into the conjunctival sac of the left eye of the animal after gently pulling the lower lid away from the eyeball. The lids were then held together gently for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. All the rabbits (one rabbit for initial test and two rabbits for confirmatory test) were treated in a similar manner. The eyes of each rabbit were examined at 1, 24, 48 and 72 hours post-instillation and scored. The grades of ocular reaction were assessed as per Draize. There were no toxic signs and pre-terminal deaths and no abnormality was detected at necropsy in any of the animals. Based on the highest total mean eye reaction score of 6.67 at 24 hours post instillation and together with the persistence of the reaction the test item Tribotecc® - Ferrostar is a “Mild Irritant” according to “Modified Version of the Kay J H and Calandra J C. (1962) System”. Based on the results of the present study the test item Tribotecc® - Ferrostar however does not need to be classified as per Regulation (EC) No 1272/2008 of the European Parliament and of the council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.