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Registration Dossier
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EC number: 701-138-0 | CAS number: 242482-67-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 23 APR 1996 to 03 MAY 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline 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
- Remarks:
- according to Principles of Good Laboratory Practice, annex of paragraph 19a, section 1 of the chemical law of July 25, 1994
Test material
- Reference substance name:
- tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate
- EC Number:
- 701-138-0
- Cas Number:
- 242482-67-3
- Molecular formula:
- C21H46N2O6
- IUPAC Name:
- tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate
- Test material form:
- other: fluid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, Biberach, Germany
- Weight at study initiation: 2.9 to 3.5 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet: ssniff K-H (V 2333), ad libitum and hay (approx. 15 g daily)
- Water: water, ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): fully air conditioned rooms
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hours (point in time at which first washing took place)
- Observation period (in vivo):
- 7 days (reading times: 1, 24, 48 and 72 hours after instillation of test material, as well as 7 days thereafter)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: details see below
SCORING SYSTEM: according to Draize
CORNEA
Degree of opacity (most dense area used)
0: No opacity
1: Scattered or diffuse areas, details of iris clearly visible
2: Easily discernible translucent areas, details of iris slightly obscured
3: Opalescent areas, no details of iris visible, size of pupil barely discernible
4: Opaque cornea, iris invisible
Affected area (opacity or stained by fluoresceine test)
0= no translucence
1 =punctate to 1/4
3 = more than 1/2 to 3/4
2 = more than 1/4 to 1/2
4 = more than 3/4 to 4/4
IRIS
0: Normal
1: 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)
2: No reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae)
0: Blood vessels normal
1: Blood vessels definitely injected above normal.
2: More diffuse, deeper crimson red, individual blood vessels not easily discernible
3: Diffuse beefy red
Chemosis (refers to palpebral and bulbar conjunctivae)
0: No swelling
1: Any swelling above normal (includes nictitating_membran)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids half closed to completely closed
Discharge
0: No discharge 0
1: Any amount different from normal (does not include small amounts normally observed in inner canthus)
2: Discharge with moistening of the lids and hairs just adjacent to the lids
3: Discharge with moistening of the lids and hairs, and considerable area around the eye
Additional information
S = slight; M=moderate; E = extreme; x= finding present; N = previous finding reversible; ? = not assessable
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- 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:
- 0
- 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:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- 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:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- One and 24 hours after application the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse beefy red colour and very slight up to obvious swellings. The iris was sporadically reddened. Additionally, clear - colourless eye discharge was noted. 48 and 72 hours after application the conjunctivae of one animal showed a diffuse crimson red or a diffuse beefy red colour and a very slight swelling. 7 days after application all signs of irritation were vanished.
- Other effects:
- No systemic effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is slightly irritating to the eyes when tested under the conditions of the OECD guideline 405. Chemosis was seen at 1 (all animals), 24 h (two animals), and 48 h (one animal) being reversible within 72 h. A redness of the conjunctivae was also seen in all animals in the 1 and 24 h reading, being fully reversibly after 7 days. Animal #1 and #3 had an iris score of 1 in the 24 h reading. These effects were fully reversible within 48 h. No corneal effects were observed.
The effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008. - Executive summary:
The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. For this purpose 0.1 mL of test material were instilled in the left conjunctival sac of three New Zealand white rabbits. Chemosis was observed in all three animals 1 h after application (maximum score observed 2). The effect was fully reversible within 72 hours. Conjunctival redness was observed in all three animals up to 72 h after application (maximum score observed 3), but was reversible within seven days. Iridial effects were noted in two animals up to 24 h (maximum score observed 1). Corneal opacity was not oberved in any animal.
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