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EC number: 700-777-2 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- Study carried out before the entry into force of amendments to annex VII
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Between 06 June 2012 and 02 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- lithium 3-((3,4-dicyanophenyl)sulfonyl)propane-1-sulfonate)
- EC Number:
- 700-777-2
- Cas Number:
- 667889-11-4
- Molecular formula:
- C11H9N2O5S2Li
- IUPAC Name:
- lithium 3-((3,4-dicyanophenyl)sulfonyl)propane-1-sulfonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Sponsor's identification: S193308
Description : white powder
Batch number : 422 (Bag 3)
Purity : 98.9%
Date received : 02 May 2012
Expiry date : not supplied
Storage conditions: room temperature in the dark
The integrity of supplied data relating to the identity, purity and stability of the test item is the responsibility of the Sponsor.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.51 to 2.85 kg and were twelve to twenty weeks old. After an acclimatisation period of at least 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 cages. Free access to mains drinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A volume of 0.1 ml of the test item, which was found to weigh approximately 72 mg.
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test item, which was found to weigh approximately 72 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made according to the six point scale shown in appendix 1.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on application of the test item, one drop of local anaesthetic (Tetracaine hydrochloride 0.5%, Bausch & Lomb, Surrey, UK) was instilled into both eyes of these animals 1 to 2 minutes before treatment.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in apppendix 2 below (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.48 to 49).
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Any clinical signs of toxicity, if present, were also recorded. An additional observation was made on Day 7 to assess the reversibility of the ocular effects. Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 72093 Male
- Time point:
- other: Highest score at 1, 24, 48, 72 hours and 7 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 72126 Male
- Time point:
- other: Highest score at 1, 24, 48, 72 hours and 7 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 72156 Male
- Time point:
- other: Highest score at 1, 24, 48, 72 hours and 7 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 72093 Male
- Time point:
- other: Highest score at 1, 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: 72126 Male
- Time point:
- other: Highest score at 1, 24, 48, 72 hours and 7 days
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: 72156 Male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 72093 Male
- Time point:
- other: Highest score at 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 72126 Male
- Time point:
- other: Highest score at 1, 24, 48, 72 hours and 7 days
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 72156 Male
- Time point:
- other: Highest score at 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- iris score
- Basis:
- animal: 72093
- Time point:
- other: Highest score at 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- animal: 72126 Male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: 72156 Male
- Time point:
- other: Highest score at 1, 24, 48, 72 hours and 7 days
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2.
Iridial inflammation was noted in one treated eye one hour after treatment. Scattered or diffuse corneal opacity and iridial inflammation were noted in this treated eye at the 24, 48 and 72 Hour observations. No corneal or iridial effects were noted in the two other treated eyes during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment. Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation noted in one treated eye at the 24 Hour observation. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation noted in two treated eyes at the 48 Hour observation. Moderate conjunctival irritation persisted in one treated eye with minimal conjunctival irritation noted in one other treated eye at the 72 Hour observation.
One treated eye appeared normal at the 72 Hour observation and two treated eyes appeared normal at the 7 Day observation. - Other effects:
- Bodyweight
Individual bodyweights and bodyweight changes are given in Table 3.
All animals showed expected gain in bodyweight during the study.
Any other information on results incl. tables
Interpretation of Results
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 cornea involved). 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
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 (seeAppendix3) was used to classify the ocular irritancy potential of the test item. This was 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 were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test item.
If evidence of irreversible ocular damage is noted, the test item will be classified as corrosive to the eye.
The results were interpreted according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances andRegulation (EC) No 1272/2008, relating to the Classification, Packaging and Labelling of Dangerous Substances.
Table 1 Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
72093Male |
72126Male |
72156Male |
|||||||||||
IPR= 3 |
IPR = 0+ |
IPR = 0+ |
||||||||||||
Time After Treatment |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
7 |
1 |
24 |
48 |
72 |
7 |
CORNEA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
10 |
10 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A = Redness |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
1 |
0 |
B = Chemosis |
1 |
1 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
1 |
1 |
1 |
1 |
0 |
C = Discharge |
2 |
1 |
0 |
0 |
2 |
2 |
1 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
Score (A + B + C) x 2 |
10 |
8 |
4 |
0 |
12 |
12 |
10 |
10 |
0 |
10 |
6 |
6 |
4 |
0 |
Total Score |
10 |
8 |
4 |
0 |
17 |
27 |
25 |
20 |
0 |
10 |
6 |
6 |
4 |
0 |
IPR= Initial pain reaction
+= One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment
Table 2 Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores At: |
||||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
|
72093Male |
10 |
8 |
4 |
0 |
- |
72126Male |
17 |
27 |
25 |
20 |
0 |
72156Male |
10 |
6 |
6 |
4 |
0 |
Group Total |
37 |
41 |
35 |
24 |
0 |
Group Mean Score |
12.3 |
13.7 |
11.7 |
8.0 |
0.0 |
- = Observation not required - considered to be zero for calculation of Group Mean Score
Table 3 Individual Bodyweights and Bodyweight Changes
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
72093Male |
Day 0 |
Day 3 |
0.05 |
2.85 |
2.90 |
||
72126Male |
Day 0 |
Day 7 |
0.08 |
2.79 |
2.87 |
||
72156Male |
Day 0 |
Day 7 |
0.14 |
2.51 |
2.65 |
Applicant's summary and conclusion
- Interpretation of results:
- other: mild irritant (Class 4 on a 1 to 8 scale)
- Remarks:
- Criteria used for interpretation of results: other: modified Kay and Calandra classification system
- Conclusions:
- The test item produced a maximum group mean score of 13.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test item did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC or the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Packaging and Labelling of Dangerous Substances.
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Result. A single application of the test item to the non-irrigated eye of three rabbits produced scattered or diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 72‑Hour observation and two treated eyes appeared normal at the 7‑Day observation.
Conclusion. The test item produced a maximum group mean score of 13.7 and was classified as a mild irritant (Class4on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test item did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC or thecriteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Packaging and Labelling of Dangerous Substances.
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