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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

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

Constituent 1
Chemical structure
Reference substance name:
Methyl(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate
Cas Number:
147118-40-9
Molecular formula:
C23H30FN3O6S
IUPAC Name:
Methyl(3R,5S,6E)-7-{4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: S&K-LAP Kft. Kartal, Hungary- Age at study initiation: adult albino male rabbits- Weight at study initiation: 2830-2932 g at study termination: 2954-3162 g- Housing: individually in metal cages.- Diet (e.g. ad libitum): ad libitum, Hair fattening mixed diet (YAQ-TÁP Kft.)- Water (e.g. ad libitum): ad libitum, tap water from watering bottles.- Acclimation period: 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 3- Humidity (%): 30-70 %- Air changes (per hr): No data- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 g of test item in pure state, as a single dose
Duration of treatment / exposure:
The eyes were not rinsed after the administration of the test item.
Observation period (in vivo):
1, 24, 48, 72 hours and 1 weeks after the application.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCEno removalSCORING SYSTEM:by Draize (1959) and OECD 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 1 week
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 1 week
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 1 week
Irritant / corrosive response data:
1 hour after the treatment - Moderate to severe chemosis and severe discharge occured.- Redness of the conjuctivae, corneal and iris alterations could not be observed in two animals due to the swelling the lids were completely closed. In third animal, slight redness was found at this time. 24 hours after the treatment - Slight to moderate redness, severe discharge, slight chemosis and cornea opacity were detected. The area of cornea involved was unchanged. The discharge observed was slight or severe in this time point. 48 hours after the treatmentOne animal became free of symptoms. Slight redness, chemosis and cornea opacity were observed. The area of cornea involved was unchanged. The discharge observed was slight or severe in this time point.1 week after the treatment the animals was symptom free.
Other effects:
The general state and behaviour of animals were normal during the whole study.There were no notable body weight changes during the contact and observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion the test item applied to the rabbit's eye mucosa, caused slight to severe conjuctival and slight corneal irritant effects fully reversible within 1 week. The test item does not have to be classified and has no obligatory labelling requirement according to both DSD and GHS criteria.