Propanedioic acid, 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]-, 1,3-dimethyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.01.1993 - 13.03.1993

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dimethyl 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]propanedioate

Cas Number:

172529-93-0

Molecular formula:

C12 H14 Cl N5 O4

IUPAC Name:

1,3-dimethyl 2-[2-(2-amino-6-chloro-9H-purin-9-yl)ethyl]propanedioate

Constituent 2

Reference substance name:

Amino-6-chloro-9-(methyl-2-carbomethoxybutanoate-4-yl)purine

IUPAC Name:

Amino-6-chloro-9-(methyl-2-carbomethoxybutanoate-4-yl)purine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

55 MG

Duration of treatment / exposure:

single application

Observation period (in vivo):

The animals were observed for up to 14 days.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Max. score:

2

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Results 5

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 7

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

2

Results 8

Irritation parameter:

chemosis score

Max. score:

2

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

1.3

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 12

Irritation parameter:

cornea opacity score

Max. score:

2

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0 (related to all animals)

Results 13

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 14

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 15

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 16

Irritation parameter:

iris score

Max. score:

1

Remarks on result:

other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 14 days

Other effects:

Dulling of the cornea in 2 animals 1 hour after start of exposure. Vascularisation of the cornea: 2 rabbits on day 7.
Ectropion - eyelids partially overted and pocess a convoluted appearance: 1 rabbit on days 3 and 7.
Discharge: observed in the 3 rabbits from 1 hour to 3 days after dosing.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

according to the OECD-Guideline 405 and the REGULATION (EC) No 1272/2008., the test material is regarded as a irritating to eyes.