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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04.02.2002 - 19.02.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-imino-1-methylimidazolidin-4-one
EC Number:
200-466-7
EC Name:
2-imino-1-methylimidazolidin-4-one
Cas Number:
60-27-5
Molecular formula:
C4H7N3O
IUPAC Name:
2-imino-1-methylimidazolidin-4-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Creatinin
- Physical state: solid
- Expiration date of the lot/batch: 28.01.2004
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 1987.4 g, 2020.9 g and 2062.7 g
- Housing: Single housed in steel cages with a plastic bottom mould and a habitat of 5445 square centimeters at the bottom and an overall height of 600 millimeters. A non-barrier system with air was used.
- Diet: ad libitum, Supplier: Altromin International, Lage, Germany; Type: 2023; Batch No. 0733
- Water: ad libitum normal tap water from municipal sources
- Acclimation period: The animals were used for a skin irritation test before, where the test substance was classified as non-irritating. The animals were observed for their health condition, therefore it was assured that the animals were in good condition for this investigation and no acclimation period was needed.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g of the test substance was applied into the right eye by pulling the lower eyelid away from the eyeball to form a cup.
Observation period (in vivo):
Examination of the treated eyes was made 1 hour and approximately 24, 48, 72 hours and 7 days after the application of the test substance.
Number of animals or in vitro replicates:
One male and two females were used.
Details on study design:
See "any other information on material and methods"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
Rabbit 501
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
Rabbit 503
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
Rabbit 502
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
Rabbit 501
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
Rabbit 503
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
Rabbit 502
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
Rabbit 501
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Rabbit 503
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
Rabbit 502
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
Rabbit 501
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
Rabbit 503
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
Rabbit 502
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Other effects:
Systemic toxic symptoms caused by the test substance were not observed during the whole study.
Body weight gain was positive and within normal range.

Any other information on results incl. tables

The Primary Irritation Index was used to classify the test substance as follows:

0 -11: non-irritant

12 - 25: midly irritating

26 - 56: moderately irritant

57 - 110: severe irritant

The Primary Irritation Idex for Creatinine was calculated to be 4 if the maximum value after one hour exposure was chosen for calculation.

Ocular Lesions:

Slight redness of the conjunctivea (injectionn of the blood vessels) was observed in all animals one hour after application of the test substance and slight chemosis was observed in two animals one hour after application. Only one animal showed a slight redness of the conjunctivae 24 hours after application. The eyes of all three rabbits were normal from the 24 hour examination on. The numerical scores awarded to the ocular reactions elicited by the test substance are presented in the following table:

 

Rabbit 501(female)

Rabbit 503 (female)

Rabbit 502 (male)

1h

24h

48h

72h

7d

1h

24h

48h

72h

7d

1h

24h

48h

72h

7d

Cornea

A

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

B

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Iris

A

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae

 

A

1

1

0

0

0

1

0

0

0

0

0

0

0

0

0

B

1

0

0

0

0

1

0

0

0

0

1

0

0

0

0

C

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Individual body weights:

Body weight gain was positive and within normal range. The data is given in the following table:

Rabbit number and sex

Weight at day 0 [g]

Weight at day 7 [g]

501 (female)

2020.9

2147.0

503 (female)

1987.4

2157.5

502 (male)

2062.7

2155.2

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study the substance Creatinine could be classified as non-irritant to the eyes
Executive summary:

The substance Creatinine was tested regarding to its irritation potential towards eyes and adjacent muscous membranes of experimental animals according to OECD Guideline No. 405 ("Acute Eye Irritation/Corrosion").

The potential to cause damage to the conjunctiva, iris and corea was assessed by single application of the test substance into the lower conjunctival sac of the eyes of two male and one female rabbit, strain New Zealand White. 0.1 g of the test substance was applied. Ocular reactions were assessed 1, 24, 48, 72 hours and 7 days after removal of the test substance. Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges.

Slight redness of the conjunctivae (injection of the blood vessels) was observed in all animals one hour after application of the test substance and slight chemosis was observed in two animals one hour after application. Only one animal showed a slight redness of the conjunctivae 24 hours after application. The eyes of all three rabbits were normal from the 24 hour examination on.

Under the conditions of this study the test substance Creatinine was classified as non-irritant to the eyes.