1,3-diethyldiphenylurea

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28.11.-5.12.2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-diethyldiphenylurea

EC Number:

201-645-2

EC Name:

1,3-diethyldiphenylurea

Cas Number:

85-98-3

Molecular formula:

C17H20N2O

IUPAC Name:

1,3-diethyl-1,3-diphenylurea

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Centralit
- Physical state: white solid crystalline
- Analytical purity: 99.9 % (w/w)
- Lot/batch No.: 0500906
- Expiration date of the lot/batch: 16.9.2016
- Stability under test conditions: stable
- Storage condition of test material: in dry room at the temperature < 40°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Age at study initiation: 2 – 5 months
- Weight at study initiation: 3.1 – 3.6 kg
- Housing: individually in metallic cages
- Diet (e.g. ad libitum): standard pelleted diet TM-MAK 1 for rabbits and guinea pigs
- Water (e.g. ad libitum): drinking tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark

STUDY TIME SCHEDULE
Animal supply: 16. 11. 2011
Experimental part of study: 28. 11. – 05. 12. 2011

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

72 h

Observation period (in vivo):

1, 24, 48, 72 hours

Number of animals or in vitro replicates:

1 male - initial test
2 males - confirmatory test

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): noSCORING SYSTEM: according to the grading system given in Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008.

TOOL USED TO ASSESS SCORE: After recording the observations at 24 hours, the eyes of rabbit were examined with the aid of fluorescein and the ophthalmoscopy.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The following changes were observed on eye at 1 hour after application: conjunctivae – diffuse, crimson colour, individual vessels not easily discernible in all rabbits and some swelling above normal in one rabbit. At 24, 48 and 72 hours after application no irritating effects of eye was observed in all animals.
No clinical signs of systemic intoxication were detected.

Evaluation of results after single application demonstrated that the test substance, Centralit, is not irritating for eye of rabbit.

Executive summary:

The test substance, Centralit, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).

The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test was performed initially using one animal. Because a corrosive or severe irritating effects were not observed in initial test, the response was confirmed using two additional animals.

The following changes were observed on eye at 1 hour after application: conjunctivae – diffuse, crimson colour, individual vessels not easily discernible in all rabbits and some swelling above normal in one rabbit (No. 16). At 24, 48 and 72 hours after application no irritating effects of eye was observed in all animals.

No clinical signs of systemic intoxication were detected.

Evaluation of results after single application demonstrated that the test substance, Centralit, is not irritating for eye of rabbit.