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 11-May-2009 to 26-May-2009
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-methyl-1-(trans-4-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide
- Cas Number:
- 1208319-26-9
- Molecular formula:
- C15H23N5O2S
- IUPAC Name:
- N-methyl-1-(trans-4-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide
Constituent 1
- Specific details on test material used for the study:
- Test material name in the study: PF-03394197-00
Batch Number: JFB80003
Purity: 97.17%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan France, Z1 Le Malcourlet, 03800 Gannat / France
- Age at study initiation: 17 weeks (male), 15 weeks (females)
- Weight at study initiation: 2697 g (male), 2582 - 3124 g (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Fullinsdorf ad libitum.
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): light cycle of 12 hours light and 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g (per animal)
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.55
- 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
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for
each animal for corneal opacity, iris, redness and cherna sis of the conjunctivae, separately. The
individual mean scores for corneal opacity and iris were 0.00 for all three animals. The
individual mean scores for the conjunctival reddening were 0.67, 0.33 and 0.67, respectively.
The individual mean scores for the conjunctival swelling was 0.00 for each of the three animals.
No abnormal findings were observed in the cornea or iris of any animal at any of the
measurement intervals. Slight reddening of both the conjunctivae and the sclerae were observed
in all three animals at the 1 hour observation after instillation. The reddening of the conjunctivae
persisted up to the 24-hour (one female) or the 48-hour (one male, one female) observation after
application.
The reddening of the sclerae persisted up to the 72-hour observation after treatment in one male
and one female. Slight ocular discharge was present at the 1 hour observations after
administration in two females.
No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the
end of the observation period for all animals. - Other effects:
- No mortality occurred.
No clinical signs were observed during the course of the study.
The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is considered to be "not irritating" to the rabbit eye.
- Executive summary:
The eye irritation study is performed according to OECD Guideline 405 under GLP. The test item is considered to be "not irritating" to the rabbit eye.
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