Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (OECD) with acceptable restrictions (observation period of 8 days, termination of the experiment in absence of reversibility.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Theophylline
EC Number:
200-385-7
EC Name:
Theophylline
Cas Number:
58-55-9
Molecular formula:
C7H8N4O2
IUPAC Name:
1,3-dimethyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione
Details on test material:
- Name of test material (as cited in study report): Theophyllin;
- Analytical purity: not reported.

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder: Gaukler, Offenbach/Main, Germany;
- Mean weight at study initiation: 3.20 kg;
- Housing: single;
- Diet (e.g. ad libitum): KLIBA 341, 4 mm, Klingenthalmuehle AG; Kaiseraugst, Switzerland. About 130 g per animal per day;
- Water (e.g. ad libitum): Tap water, about 250 mL per animal per day;
- Acclimation period: At least 8 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C;
- Humidity (%): 30 - 70 %;
- Photoperiod (hrs dark / hrs light): 12h/12h.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 51 mg of the solid test substance).
- Concentration (if solution): undiluted.

Duration of treatment / exposure:
Single application; test substance was not washed out.
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 males
Details on study design:
APPLICATION SITE:
Single application to the conjunctival sac of the right eyelid;

REMOVAL OF TEST SUBSTANCE
- The test substance is not washed out.

READINGS: 1, 24, 48, 72 hours and 8 days after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
4
Reversibility:
not fully reversible within: 8 days.
Remarks on result:
other: One animal showed score 1 after 8 days.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.8
Max. score:
3
Reversibility:
not fully reversible within: within 8 days.
Remarks on result:
other: One animal showed score 2 after 8 days.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Very slight corneal opacity was observed in 1-2 rabbits up to day 8. Slight to well-defined conjunctival redness and conjunctival swellings were observed in all 3 rabbits up to 72h and 48h, respectively. The findings were reversible in 2 of the 3 animals. On day 8 one animal showed conjuctiva redness (grad 2) and slight cornea opacity (grad 1) and keratitis. The effects could possible be due to mechanical irritation by the crystalline test substance. The iris was unaffected in each animal at each time.

Any other information on results incl. tables

Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out.

Animal

Reading

Cornea

Opacity

Iris

Conjunctiva

Redness

Chemosis

Additional findings

 

 

 

 

 

 

 

1

1 h

0

0

2

2

 

2

1 h

0

0

2

2

 

3

1 h

0

0

2

2

 

1

24 h

1

0

2

2

 

2

24 h

1

0

2

1

small retractions in the eyelids

3

24 h

0

0

2

1

 

1

48 h

1

0

2

1

small retractions in the eyelids

2

48 h

1

0

2

0

small retractions in the eyelids

3

48 h

0

0

2

0

 

1

72 h

1

0

2

0

small retractions in the eyelids / Keratitis

2

72 h

0

0

1

0

small retractions in the eyelids

3

72 h

0

0

1

0

 

1

8 d

1

0

2

0

small retractions in the eyelids / Keratitis

2

8 d

0

0

0

0

small retractions in the eyelids

3

8 d

0

0

0

0

 

mean animal 1

24 - 72 h

1.00

0.00

2.00

1.00

 

mean animal 2

24 - 72 h

0.67

0.00

1.67

0.33

 

mean animal 3

25 - 72 h

0.00

0.00

1.67

0.33

 

mean

24 - 72 h total

0.56

0.00

1.78

0.56

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS