Adenosine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Peer reviewed study performed following the method of Draize, method well documented, without detailed results documentation

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Draize Test: the substance to be tested is applied in a single dose to one of the eyes of the experimental animal; the untreated eye serves as the control. The degree of eye irritation/corrosion is evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Adenosine

EC Number:

200-389-9

EC Name:

Adenosine

Cas Number:

58-61-7

Molecular formula:

C10H13N5O4

IUPAC Name:

adenosine

Test animals / tissue source

Species:

rabbit

Strain:

other: Japanese white

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Takeo Breeder (Shizuoka, Japan)
- Age at study initiation: not specified
- Sex: female
- Weight at study initiation: 2.0 -2.2 kg
- Housing: Metal cages (39 x 40 x 44 cm)
- Diet: RC4 Diet (Oriental Yeast Co., Tokyo, Japan) ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/- 1 °C
- Humidity (%): 55 +/- 5 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h dark/light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye was left untreated as blank

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

Chemicals were not rinsed

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

Three

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
Cornela opacity, erythema, chemosis, secretat and iritis were classified using the Draize score.

Observation: 1, 4, 24, 72, 96 hr, 7, 14 and 21 days after treatment with the chemical

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Substance was classified in a group of chemicals that produce no or minimal irritation fully reversible within 24 h

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Substance was classified in a group of chemicals that produce no or minimal irritation fully reversible within 24 h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Substance was classified in a group of chemicals that produce no or minimal irritation fully reversible within 24 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Substance was classified in a group of chemicals that produce no or minimal irritation fully reversible within 24 h

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Adenosine (CAS 58-61-7) was classified into a group of chemicals that induce no or minimal irritation, which is fully reversible after 24 h. Therefore, Adenosine does not require classification according to the UN GHS classification and the CLP classification system.

Executive summary:

This study was performed to correlate eye irritation ratings with molecular descriptors and develope a QSAR model.

130 heterogeneous chemicals were tested, among them Adenosine (CAS 58-61-7).

100 mg or 0.1 ml of the test chemicals were placed in the conjuctival sac of the left eye of 3 female japanese white rabbits. The left eye was left untreated as blank. The grade of ocular reaction was recorded at defined intervals up to 21 days. The chemicals were classified in three categories: Class I chemicals induced no or minimal irritation that fully reversed in 24 h, Class II chemicals induced damages persisting for more that 24 h, but fully recovering until 21 days, and Class III chemical which induced damages that were not reversible after 21 days.

Adenosine (CAS 58-61-7) was classified as Class I: chemicals that induce no or minimal irritation fully reversible after 24 h.

Therefore, Adenosine does not require classification according to the UN GHS classification and the CLP classification system.