Registration Dossier
Registration Dossier
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EC number: 834-894-6 | CAS number: 113601-85-7
- 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
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- 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
Endpoint summary
Administrative data
Description of key information
In-Vivo Skin irritation:
SN-475N does not require classification as a skin irritant.
In-Vivo Eye irritation:
SN-475N does not require classification as a eye irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 October 2012 to 19 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In-Vivo study carried out as substance is intended for global registration where In-Vivo data is required.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See any other information section for details
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See any other information section for details
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- See any other information section for details
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- No further details specified in the study report
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- EXPERIMENTAL ANIMALS
Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft.
2173 Kartal, Császár út 135, HUNGARY
Justification of strain: The New Zealand White albino rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test.
Number of animals: 3
Age of animals at treatment: ~14 - 15 weeks old
Sex: Male
Body weight range at the
beginning of the in-life phase: 3477 – 3618 g
end of the in-life phase: 3572 – 3701 g
Acclimation time: 33 days
Animal identification: The animals were identified by engraved ear tags. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal number.
Husbandry
Number of animal room: 618
Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature range during
the study: 18.5-22.2 °C
Relative humidity during
the study: 38 – 82 %
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour
The temperature and relative humidity values were measured continuously. The measured range was checked at least daily during the acclimatisation and experimental phases.
Variation from the target relative humidity (max. 82 %) was observed during the acclimation period. These deviations were considered to have no impact on the animal health, as certified by the Clinical Veterinarian, or on the outcome of the study and interpretation of the results.
Food and Feeding
Animals received UNI diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary, ad libitum. Animals were provided with the following batch:
• 0140 07 12, expiry date: 25 October 2012
The details of the diet used will be archived with the raw data and are not reported.
Water Supply
The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.
Water Analysis
The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. The quality control analysis is performed once every three months and microbiological assessment is performed monthly by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). Copies of the relevant Certificates of Analysis are retained in the archives at CiToxLAB Hungary Ltd. - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- The test item was used as supplied, as a single dose of 0.5 g, applied to the test area.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- To assess skin irritation, animals were examined at 1, 24, 48, and 72 hours after the patch removal. Additional general examinations were performed daily.
- Number of animals:
- 3
- Details on study design:
- TREATMENT PERIOD
Day of treatment
Day 0
16 October 2012
Animal skin examination and assignment to study
Day 0 (pre-treatment)
16 October 2012
Body weight measurement
Day 0, 3
16 and 19 October 2012
Clinical observation
Scoring at 1, 24, 48 and 72 hours after treatment
(16, 17, 18 and 19 October 2012)
End of in life phase
Day 3
19 October 2012
ADMINISTRATION OF THE TEST ITEM
Dosage
The test item was used as supplied, as a single dose of 0.5 g, applied to the test area. The untreated skin of each animal served as a control. The test item was powdered which was dispensed for studies with this test item.
Application of the Test Item
Patch testing was used to detect primary irritating effects of the test item. Three male animals in acceptable health condition were selected for this test.
Approximately 24 hours prior to the test, the hair was clipped from the back and flanks of the animals. Removal of hair was performed in two steps. The majority of hair was clipped with an electronic hair clipper and the remaining hair was moistened with water and shaved with a razor.
The test item was applied to an approximately 6 cm² area of intact skin as follows:
• A single layer of a fine medical gauze (open-weave with large holes) of approximately 5x5 cm was placed over the application area,
• The appropriate amount of test item was carefully spread over the application area (the gauze helped maintain the test item in place),
• Three more layers of gauze were placed over the test item,
• These gauze patches were kept in contact with the skin by a patch of clear plastic with a surrounding adhesive hypoallergenic plaster to ensure continued good contact between the moistened test item and the shaved skin.
• The entire trunks of the animals were wrapped with plastic wrap for 4 hours.
• Medical elastic tubing was placed over the plastic to keep it in place.
An initial test was performed using one animal. Three minutes and one hour after application of the test item, the application site was examined. No severe irritation or corrosive effect was found in the initial test, therefore the bandage was replaced and the exposure continued for a further 3 hours (a total 4 hours exposure). Two additional animals were then included in the study.
Duration of Exposure
Duration of exposure: 4 hours. After the treatment period, the test item was removed with water at body temperature.
OBSERVATIONS AND SCORING
Clinical Observations
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes and then at 24, 48 and 72 hours after patch removal.
Scoring and Assessment of Local Reactions
The dermal irritation scores were evaluated according to the scoring system by Draize (1959) shown in Appendix 1. The animals were observed for 72 hours and the duration of the study was sufficient to evaluate fully the reversibility or irreversibility of the effects observed. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects:
- Measurement of Body Weight
Body weights were recorded at the beginning and at the end of experiment.
Termination
At the end of the observation period, euthanasia of the animal was by intramuscular injections of CP-Ketamin 10 % and CP-Xylazin 2 % followed by i.v. Euthasol® 40% anaesthesia (see details in 3.1.2.). Death was verified by checking pupil and cornea reflex, absence of respiration and pulse. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- SN-475N does not require classification as a skin irritant.
- Executive summary:
An acute skin irritation study was performed with SN-475N in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).
A volume of 0.5 g test item was applied to the skin of the experimental animals. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin. Sterile gauze pads were placed on the skin of rabbits. These gauze pads were kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.
After 4 hours, the remaining test item was removed with water at body temperature.
To assess skin irritation, animals were examined at 1, 24, 48, and 72 hours after the patch removal. Additional general examinations were performed daily.
There was no mortality during the observation period.
There was no test item related effect on body weight.
At observation one hour after patch removal, oedema (score 1) on 1/3 animals were observed on the skin of the treated animals.
At observation 24, 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.
As no clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72 hours observation.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.00, 0.00 and 0.00 respectively.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.
The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.00.
According to Directive 2001/59/EC, SN-475N does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, SN-475N does not require classification as a skin irritant.
According to the classification system based on the scheme devised by Draize (1959), SN-475N is a "non-irritant"
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Justification for type of information:
- In-vivo study carried out as substance is intended for global registration where in-vivo data is required.
Referenceopen allclose all
SCORING OF ERYTHEMA FORMATION
Animal No./ Sex |
Body weight (g) |
1 h |
24 h |
48 h |
72 h |
|
At the beginning of the study |
At the end of the study |
|||||
2607 / M |
3618 |
3701 |
0 |
0 |
0 |
0 |
2643 / M |
3477 |
3572 |
0 |
0 |
0 |
0 |
2606 / M |
3552 |
3644 |
0 |
0 |
0 |
0 |
Total |
- |
- |
0 |
0 |
0 |
0 |
M = male
h = hour
SCORING OF OEDEMA FORMATION
Animal No./ Sex |
Body weight (g) |
1 h |
24 h |
48 h |
72 h |
|
At the beginning of the study |
At the end of the study |
|||||
2607 / M |
3618 |
3701 |
1 |
0 |
0 |
0 |
2643 / M |
3477 |
3572 |
0 |
0 |
0 |
0 |
2606 / M |
3552 |
3644 |
0 |
0 |
0 |
0 |
Total |
- |
- |
1 |
0 |
0 |
0 |
M = male
h = hour
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- In-Vivo study carried out as substance is intended for global registration where In-Vivo data is required.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2012 to 26 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In-Vivo study carried out as substance is intended for global registration where In-Vivo data is required
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See other information on method section for details
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- See other information on method section for details
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- See other information on method section for details
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- No further details specified in the study report
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- EXPERIMENTAL ANIMALS
Species and strain: New Zealand White rabbit
Source: S&K-LAP Kft.
2173 Kartal, Császár út 135, Hungary
Justification of strain: The New Zealand White rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animal in acceptable health condition was used for the test. Both eyes of animal provisionally selected for testing were examined prior to starting the study.
Number of animals: 3 animals
Age of animals at treatment: ~14-15 weeks old (young adult)
Sex: Male
Body weight at the
beginning of the in-life phase: 3756-3828 g
end of the in-life phase: 3822-3897 g
Date of receipt: 13 and 19 September 2012
Acclimatization time: At least 34 days
Animal identification: The individual identification was by engraved ear tag. The cage was marked with individual identity card with information about study code, sex, dosage, cage number and individual animal number.
HUSBANDRY
Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 609
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature
during the in-life phase: 17.5 – 22.2°C
Relative humidity
during the in-life phase: 40 – 82 %
Housing/Enrichment: Rabbit was individually housed in AAALAC approved metal wire rabbit cages. Cage was of an open wire structure and cage was placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour.
The temperature and relative humidity values were measured continuously. The measured range was checked at least daily during the acclimatisation and experimental phases.
Variations from the target relative humidity (max. 82 %) were observed during the acclimation period. These deviations were considered to have no impact on the animal health, as certified by the Clinical Veterinarian, or on the outcome of the study and interpretation of the results.
FOOD AND FEEDING
Animals received diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum (Batch number: 0140 07 12 Expiry date: 25 October 2012,). The details of diets used will be archived with the raw data and are not reported.
WATER SUPPLY AND QUALITY CONTROL OF WATER
The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system. The quality control analysis is performed once every three months and microbiological assessment is performed monthly, by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201
Veszprém, József A.u.36., Hungary). The quality control results are retained in the archives of CiToxLAB Hungary Ltd. - Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- A single volume of 0.1g of the solid test item SN-475N was administered to the animals.
- Duration of treatment / exposure:
- The treated eye was rinsed with physiological saline solution at 1 hour observation.
- Observation period (in vivo):
- 72 hours
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- ADMINISTRATION OF THE TEST ITEM
Dosage
A single volume of 0.1g of the solid test item SN-475N was administered to the animals.
Application of the Test Item
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition and any with ocular lesions were rejected.
An initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item. The contra lateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made according to the six point scale.
After consideration of the ocular responses produced in the first animal, one hour after the treatment of the first animal, two additional animals were treated.
Duration of Exposure
The treated eye was rinsed with physiological saline solution at 1 hour observation.
OBSERVATIONS AND SCORING
Clinical Observations
The eyes were examined at 1, 24, 48 and 72 hours after the application. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill-health during the study were recorded. At the end of the observation period, the animals were sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol® 40% anaesthesia. Death was verified by checking pupil and corneal reflex and the absence of respiration.
Scoring and Assessment of Local Reaction
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002)
Classification of the Test Items
Individual reactions of the animal were recorded at each observation time. The nature, severity and duration of all lesions observed were described.
Results were presented and interpreted according to Regulation (EC) No 1272/2008 and UN Globally Harmonised System of Classification and Labelling of Chemicals.
Measurement of Body Weight
Individual body weight was recorded at the beginning (the day of treatment) and end of the experiment. - Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Examination of eye-irritancy
The eyes were examined at 1, 24, 48 and 72 hours after the application.
Initial Pain Reaction (IPR) (score 2) was observed in two animals and (score 1) in one animal.
One hour after the application, conjunctival redness (score 2) was seen in all animals, conjuctival chemosis (score 2) was observed in one animal and (score 1) in two animals, discharge (score 2) was seen in all rabbits.
At 24 hours after treatment, conjunctival redness (score 2) was seen in all animals, discharge (score 1) was seen in one rabbit.
At 48 hours after treatment, conjunctival redness (score 1) was seen in all animals.
At 72 hours after treatment, no signs of eye irritation or other clinical signs were observed. - Other effects:
- MORTALITY
There was no mortality observed during the study.
BODY WEIGHTS
The body weight and body weight change were considered to be normal with no indication of a treatment related effect.
CLINICAL OBSERVATION
General daily examination
There were no clinical signs observed that could be related to treatment. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item SN-475N (Batch No.: 90603), applied to rabbit eye mucosa, caused conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 72 hours. Not classified as eye irritant.
- Executive summary:
An acute eye irritation study of the test item SN-475N was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).
The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A single volume of 0.1 g of the test item was administered as a single dose.
Individual body weight was recorded at the beginning (the day of treatment) and end of the experiment. Morbidity and clinical signs of toxicity were checked daily. The eyes were examined at 1, 24, 48 and 72 hours after the application.
Initial Pain Reaction (IPR) (score 2) was observed in two animals and (score 1) in one animal.
One hour after the application, conjunctival redness (score 2) was seen in all animals, conjuctival chemosis (score 2) was observed in one animal and (score 1) in two animals, discharge (score 2) was seen in all rabbits.
At 24 hours after treatment, conjunctival redness (score 2) was seen in all animals, discharge (score 1) was seen in one rabbit.
At 48 hours after treatment, conjunctival redness (score 1) was seen in all animals.
At 72 hours after treatment, no signs of eye irritation or other clinical signs were observed.
As all signs of eye irritation had fully reversed the study was terminated after a period of 72 hours observation.
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
The body weight of the treated rabbits was considered to be within the normal range of variability.
The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:
chemosis : 0.00, 0.00, 0.00
discharge : 0.33, 0.00, 0.00
redness : 1.00, 1.00, 1.00
cornea opacity : 0.00, 0.00, 0.00
iris : 0.00, 0.00, 0.00
The test item SN-475N (Batch No.: 90603), applied to rabbit eye mucosa, caused conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 72 hours.
According to Regulation (EC) No 1272/2008, SN-475N does not require classification as an eye irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, SN-475N does not require classification as an eye irritant.
Referenceopen allclose all
Study Code: 12/356-005N
Species: NZW Rabbit
Dose: 0.1 g
Sex: Male
Start of Exposure: 23 October 2012
Test Item: SN-475N
Abbreviations:
R = Redness, OD = Opacity degree of density,
CH = Chemosis, OE = Extent of opaque area,
D = Discharge, IPR = Initial pain reaction
Time of Observation: Day 0
Time |
Animal No. |
Score of irritation |
IPR |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
||||||
R |
CH |
D |
OD |
OE |
R |
|||||
1 hour |
2639 |
2 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
1 |
2646 |
2 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
|
2601 |
2 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
2 |
Time of Observation: Day 1
Time |
Animal No. |
Score pf irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
24 hours |
2639 |
2 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
2646 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2601 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Time of Observation: Day 2
Time |
Animal No. |
Score pf irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
48 hours |
2639 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2646 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2601 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Time of Observation: Day 3
Time |
Animal No. |
Score pf irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
72 hours |
2639 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2646 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2601 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean Values of Eye Irritation (24, 48, 72 hour reading)
Study Code: 12/356-005N
Species: NZW Rabbit
Dose: 0.1 g
Sex: Male
Start of Exposure: 23 October 2012
Test Item: SN-475N
Animal Number |
Sex |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
2639 |
Male |
0.00 |
0.00 |
1.00 |
0.00 |
0.33 |
2646 |
Male |
0.00 |
0.00 |
1.00 |
0.00 |
0.00 |
2601 |
Male |
0.00 |
0.00 |
1.00 |
0.00 |
0.00 |
Body Weight Data
Animal Number |
At the beginning of experiment (Day of treatment) (g) |
At the end of experiment (72 hours after treatment) (g) |
Body weight gain (g) |
2639 |
3787 |
3846 |
59 |
2646 |
3756 |
3822 |
66 |
2601 |
3828 |
3897 |
69 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to Directive 2001/59/EC, SN-475N does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, SN-475N does not require classification as a skin irritant.
According to the classification system based on the scheme devised by Draize (1959), SN-475N is a "non- irritant".
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