Urea, reaction products with diethylene glycol, formaldehyde and glyoxal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 437

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fixapret PC, vor Magnesiumchlorid-Zugabe

IUPAC Name:

Fixapret PC, vor Magnesiumchlorid-Zugabe

Details on test material:

- Name of test material (as cited in study report): Fixapret PC, vor Magnesiumchlorid-Zugabe
- Physical state: liquid
- Analytical purity: Reaction product of urea, formaldehyde, glyoxal and diethylene glycol, content: 62.1 % in water
- Impurities (identity and concentrations): 37.9 % water (solvent)
- Lot/batch No.: 153
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor,
and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature; avoid temperatures < 5°C >30°C

Test animals / tissue source

Species:

other: Bovine cornea

Strain:

not specified

Details on test animals or tissues and environmental conditions:

not applicable: in vitro study

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

750µl of undiluted test substance

Duration of treatment / exposure:

10 min incubation time

Observation period (in vivo):

2-hours post-incubation period

Number of animals or in vitro replicates:

8 corneas (3 test substance, 3 negative control, 2 positive control)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: in vitro irritation score (IVIS), test substance

Basis:

mean

Time point:

other: 2 hours

Score:

-4.6

Remarks on result:

other: IVIS > 55: risk of serious damage to the eyes; IVIS < 55: no risk of serious eye damage

Results 2

Irritation parameter:

other: in vitro irritation score (IVIS), negative control

Basis:

mean

Time point:

other: 2 hours

Score:

4.5

Remarks on result:

other: the negative control gave the expected result (IVIS < 55)

Results 3

Irritation parameter:

other: in vitro irritation score (IVIS), positive control

Basis:

mean

Time point:

other: 2 hours

Score:

130.1

Remarks on result:

other: the positive control gave the expected result (IVIS > 55)

Any other information on results incl. tables

The BCOP test showed the following results:

Testsubstance	Mean Opacity Value	Mean Permeability Value	In Vitro Irritancy Score
11/0428-1	-4.5	-0.007	-4.6
NC	4.6	-0.006	4.5
PC *	88.3	2.784	130.1

* Values based on two corneas

In Vitro Irritancy Score	Prediction
> 55	risk of serious damage to the eyes
≤ 55	no risk of serious damage to the eyes

Based on the observed results it was concluded, that Fixapret PC, vor Magnesiumchlorid-Zugabe does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. The test method does not yet allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance. For final assignment of a risk phrase at present, results from another study would be needed.

Applicant's summary and conclusion

Interpretation of results:

other: no serious eye damage