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EC number: 419-710-0 | CAS number: 42774-15-2 NYLOSTAB S-EED; NYSEED
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline conform GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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
Test material
- 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: E.S.D. (Chatillon-sur-Chalaronne, France)
- Age at study initiation: 3 months
- Weight at study initiation: 2 -3 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): 150 g/animal/day of pelleted complete rabbit diet (Diet reference 11 C-10-Usine d'Alimentation Rationelle, Epiny-sur-Orge, France)
- Water (e.g. ad libitum): softened and filtered amins drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19+/-3°C
- Humidity (%): >/= 45%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 64 mg (quantity corresponding to a vloume of 0.1 mL)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Method of administration
Each animal was immobilised in a restraining box. The test article was administered into the inferior conjunctival sac of the right eye of each of the rabbits, the left eye serving as control. The lower and upper eyelids were held in contact for a few seconds to prevent loss of the test item. To prevent rubbing of the eye, the animals were kept in restraining boxes for about 1 h after treatment. They were then returned to their individual cages.
- Duration of treatment
After 24 h, the possible presence of corneal erosion was demonstrated uding flourescein which was eliminated with lukewarm tap water.
SCORING SYSTEM:
A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4
IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2
CONJUNCTIVAE
A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3
B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Reversibility of the observed effects (chemosis mean grade 1.4, redness mean grade 1.6, cornea mean score grade 2 and iris mean score grade 1): Changes fully reversible within 14 days
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With reference the reported scores andreversibility of effects within 14 days N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide has to be classified as irritant to the eyes (H 319) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405.
Effects on conjunctivae (redness and swelling), as well as iris congestion and cornea opacity were observed in all animals one hour after application. These signs were fully reversible within 14 days.
With reference the reported scores andreversibility of effects within 14 days N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide has to be classified as irritant to the eyes (H 319) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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