[No public or meaningful name is available]

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 19 Dec 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

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

Test material information

Constituent 1

Reference substance name:

potassium (trans-4-(methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino)-cyclohexyl)-methanesulfonate

Cas Number:

2124221-14-1

Molecular formula:

C14H19KN4O3S

IUPAC Name:

potassium (trans-4-(methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino)-cyclohexyl)-methanesulfonate

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, on 02 Nov 2016
- Age at study initiation: The male animals were born on 09 Jul2016 and/or 16 Jul2016 and the female
animal was born on 16 Ju12016.
- Weight at study initiation: The pre-test body weight range was 3.0 -3.2 kg.
- Housing: The animals were individually housed in suspended wire-bottom cages. Absorbent paper b
edding 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): temperature controlled
- 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:

0.1 ml equivalent (59 mg)

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

14 days

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.78

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

1

Reversibility:

fully reversible within: 8 days

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 term
ination.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is slightly irritant to rabbit eyes.

Executive summary:

The eye irritation study is performed using rabbit eyes, according to OECD Guideline 405 under GLP.
The substance is slightly irritant to rabbit eyes. While based on GHS, it is not classified as eye irritant.