3-methyl-1,1-diphenylurea

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16.02.-24.02.2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-1,1-diphenylurea

EC Number:

236-039-7

EC Name:

3-methyl-1,1-diphenylurea

Cas Number:

13114-72-2

Molecular formula:

C14H14N2O

IUPAC Name:

3-methyl-1,1-diphenylurea

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material: 3-Methyl-1,1-diphenylurea- Physical state: white solid powder- Composition of test material, percentage of components: main component: 3-Methyl-1,1-diphenylurea CAS:13114-72-2 >98% (w/w) impurities: unlisted additives: unlisted-Molecular formula: C14H14N2O-Molecular weight: 226,27-Batch No.: 14015- Expiration date of the lot/batch: 11/2019- Stability under test conditions: stable- Storage condition of test material: in closed container, in dry room at room temperature (at laboratory conditions)

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, RČH CZ 21760152- Weight at study initiation: 2,4-2,8 kg- Housing: Conventional animal room – individually in metallic cages- Diet: Pelleted standard diet for experimental animals ad libitum- Water: Drinking tap water ad libitum (quality corresponding to the Regulation No.: 252/2004 Czech Coll. of Law) - Acclimation period: yesENVIRONMENTAL CONDITIONS- Room temperature: 20± 3°C, permanently monitored - Relative humidity: 30 – 70%, permanently monitored- Light period: 12 hour light/12 hour dark Study Time ScheduleAnimal supply: 03. 02. 2015Experimental part of study: 16. 02. – 24. 02. 2015Evaluation of results and final report elaboration: 24. 02. – 03. 03. 2015

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL- Amount(s) applied: 0,1 g- Test substance: it was used in delivery form-pH approximately 7

Duration of treatment / exposure:

24h

Observation period (in vivo):

1, 24, 48, and 72 hours

Number of animals or in vitro replicates:

1 female/initial test2 females/confirmatory test

Details on study design:

APPLICATION OF THE TEST SUBSTANCE- The test substance was placed in the conjunctival sac of one eye of animal after gently pulling the lower lid away from the ball. CLINICAL OBSERVATIONThe eyes were examined at 1, 24, 48 and 72 hours after application. After recording the observations at 72 hours, the eyes of rabbit were examined with the aid of fluorescein and the ophthalmoscopy. The grades of ocular reaction for single animal (observation of conjunctivae, cornea and iris) were recorded at each examination. In the end of observation period the animals were sacrificed by injection of veterinary preparation T61 (1 mL/kg).TOOL USED TO ASSESS SCORE: fluorescein and ophthalmoscopy

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 7,8.10

Time point:

other: 24,48,72h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: 7,8,10

Time point:

other: 24,42,72h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: 7,8,10

Time point:

other: 24,48,72h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 7,8,10

Time point:

other: 24,48,72h

Score:

0

Max. score:

0

Any other information on results incl. tables

Table No. 5 – Summary results of reaction of treated eye(grades)

Animal No.	Ocular lesions	Time interval of examination
		1h	24h	48h	72h
7	Cornea Iris Conjunctivae Chemosis	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0
8	Cornea Iris Conjunctivae Chemosis	0 0 1 0	0 0 0 0	0 0 0 0	0 0 0 0
10	Cornea Iris Conjunctivae Chemosis	0 0 0 0	0 0 0 0	0 0 0 0	0 0 0 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No changes were observed on eye at 1 hour after application: only in animals No. 8: Conjunctivae - Some blood vessels were hyperaemic (injected). No negative changes of eyes of all rabbits were observed for the rest of the study. During the observation period (24, 48 and 72 hours after application) no irritating effects on the eye was observed in all animals. No clinical signs of systemic intoxication were detected.Akardit, is not irritating to eye of rabbit.

Executive summary:

The test substance, Akardit, 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 (No. 7). Because no corrosive or severe irritating effects were observed in initial test, the response was confirmed using two additional animals (No. 8 and No. 10).

 

No changes were observed on eye at 1 hour after application: only in animal No. 8: Conjunctivae -Some blood vessels were hyperaemic (injected).

No pathological changes of eyes of all rabbits were observed for the rest of the study. During the observation period (24, 48 and 72 hours after application) no irritating effects on the 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, Akardit,is not irritating to the eye of rabbit.