Registration Dossier
Registration Dossier
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EC number: 256-289-0 | CAS number: 46948-72-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-11-13 to 1984-12-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, guideline conform GLP study, which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 6-[methyl(phenylsulphonyl)amino]hexanoic acid
- EC Number:
- 256-289-0
- EC Name:
- 6-[methyl(phenylsulphonyl)amino]hexanoic acid
- Cas Number:
- 46948-72-5
- Molecular formula:
- C13H19NO4S
- IUPAC Name:
- 6-(N-methylbenzenesulfonamido)hexanoic acid
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 1.8 - 3.0 kg
- Labelling: earmarks
- Housing: individually in cages; air-conditioned
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 hours periodically
Test system
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 100 mg
- Concentration (if solution): 100 mg test item in 0.2 mL of 0.9 % (w/w) of NaCl solution - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours p.a.
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 day
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 1 h/24 h/48 h/72 h/7 days/ 14 days/ 21 days
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- After the application of the test item, the conjunctiva of the animals showed obvious until strong swelling as well as diffuse and strong redness. All animals showed hyperemia of the iris. The opacities of the cornea were pearl white and no details of the iris could be recognized. The surface of the cornea were uneven. All irritations co-occured with white segregations. On day 7 p.a. all irritations were weakened. One animal showed vaskularisation. On day 21 all animals showed no irritations any more.
Applicant's summary and conclusion
- Conclusions:
- According the guideline 83/467/EWG the test item has to be classified as irritating R41 - Risk of serious damage to eyes. According to GHS the test item has to be classified as H318 categorie 1 - Causes serious eye damage.
- Executive summary:
The primary eye irritation potential of the registration substance was evaluated in the New Zealand albino rabbit according to OECD test guideline 405. Only animals without ocular abnormalities were used for the study. 100 mg of the test material (in 0.2 mL 0.9% NaCl solution) was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. An additional examination was performed after 7, 14 and 21 days because there were still effects on the treated eyes after 72 hours.
After the application of the test item, the conjunctiva of the animals showed obvious until strong swelling as well as diffuse and strong redness. All animals showed hyperemia of the iris. The opacities of the cornea were pearl white and no details of the iris could be recognized. The surface of the cornea were uneven. All irritations co-occured with white segregations. On day 7 p.a. all irritations were weakened. One animal showed vaskularisation. On day 21 all animals showed no irritations any more.
According to the guideline 83/467/EWG the test item has to be classified as irritating R41 - Risk of serious damage to eyes. According to GHS the test item has to be classified as H318 categorie 1 - Causes serious eye damage.
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