Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 05 Dec 2016 to 16 Dec 2016
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- trans-(4-(methylamino)cyclohexyl)methanesulfonic acid
- Cas Number:
- 2124221-12-9
- Molecular formula:
- C8H17NO3S
- IUPAC Name:
- trans-(4-(methylamino)cyclohexyl)methanesulfonic acid
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA
- Age at study initiation: The male animals were born on 27 Aug 2016 and the female animal was born on 20 Aug 2016.
- Weight at study initiation: The pre-test body weight range was 2.4 - 2.7 kg.
- Housing: The animals were individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml equivalent (60 mg) - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- two males, one female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:
SCORING SYSTEM: Ocular reactions were graded according to the numerical Draize technique.
TOOL USED TO ASSESS SCORE: Sodium fluorescein dye procedures were performed at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Other effects:
- Systemic observations: No abnormal physical signs were observed.
Body Weights: Two animals gained weight and one animal's weight remained the same by study termination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to rabbit eyes.
- Executive summary:
The study is performed according to OECD Guideline 405. It is concluded that the test item is not irritating to rabbit eyes.
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