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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:
2001-04-16 to 2001-04-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
EC Number:
241-523-6
EC Name:
N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
Cas Number:
17526-94-2
Molecular formula:
C13H20N4O2
IUPAC Name:
3-[3-(dimethylcarbamoylamino)-4-methylphenyl]-1,1-dimethylurea
Constituent 2
Chemical structure
Reference substance name:
3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
Cas Number:
17607-23-7
Molecular formula:
C13H20N4O2
IUPAC Name:
3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
impurity 1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Water
impurity 2
Reference substance name:
unknown
IUPAC Name:
unknown
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: no data
- Weight at study initiation: 4.7 kg, 4.3 kg, 3.0 kg
- Housing: Serni-barrier in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 55+/-10%
- Air changes (per hr): at 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

The properly grind test item was used as delivered by the sponsor.
Duration of treatment / exposure:
as long as observation period. The eyes were not washed after treatment.
Observation period (in vivo):
Animals were observed 72 h respectively and furthermore until the disappea­ rance ofthe symptoms. This was achieved at 48 h for animal No 375, at 96 h ofanimal No 358 and at 192 h for animal No 357.
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: At the end of the observation period the eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo®, Lot H 901).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
: Individual and total mean cumul. score - 24, 48, 72 hour reading
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 144 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
: Individual and total mean cumul. score - 24, 48, 72 hour reading
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
: Individual and total mean cumul. score - 24, 48, 72 hour reading
Basis:
mean
Time point:
24/48/72 h
Score:
0.89
Max. score:
2
Reversibility:
fully reversible within: 192 h
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Other effects:
no other effects

Any other information on results incl. tables

Table 1: Individual eye irritation scores

Animal number

Hour p.a.

Cornea

Iris

Conjunctivae

A

B

C

T/C

T/C

T/C

T/C

T/C

357

1

0/0

0/0

1/0

0/0

0/0

 

24

0/0

0/0

1/0

0/0

0/0

 

48

1/0

0/0

2/0

0/0

0/0

 

72

1/0

0/0

1/0

0/0

0/0

 

96

1/0

0/0

1/0

0/0

0/0

 

120

1/0

0/0

1/0

0/0

0/0

 

144

0/0

0/0

1/0

0/0

0/0

 

168

0/0

0/0

1/0

0/0

0/0

 

192

0/0

0/0

0/0

0/0

0/0

358

1

0/0

0/0

1/0

0/0

0/0

 

24

0/0

0/0

1/0

0/0

0/0

 

48

0/0

0/0

1/0

0/0

0/0

 

72

0/0

0/0

1/0

0/0

0/0

 

96

0/0

0/0

0/0

0/0

0/0

375

1

0/0

0/0

1/0

0/0

0/0

 

24

0/0

0/0

1/0

0/0

0/0

 

48

0/0

0/0

0/0

0/0

0/0

 

72

0/0

0/0

0/0

0/0

0/0

T=Test, C=Control; A=Redness; B=Chemosis; C=Discharge;

marked figures=used for calculation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results it is concluded that TDI-Urone is slightly irritating to the eyes of rabbits but not relevant for classification.
Executive summary:

In a primary eye irritation study according to OECD 405 0.1 g TDI-Urone were applied unchanged into the conjunctival sac of 3 female New Zealand White rabbits (Crl:KBL (NZW) BR). Eyes were not washed after treatment. Animals were observed 72 h respectively and furthermore until the disappearance of the symptoms. This was achieved at 48 h for animal No 375, at 96 h of animal No 358 and at 192 h for animal No 357. Irritation was scored by the method of Draize.

The test item produced redness of the conjunctivae in all three animals as well as opacity of the comea in one animal. Effects were fully reversible.

No comeal lesions were found upon fluorescein examination at the final readings.

In this study TDI-Urone was found to be slightly irritating to the eyes of rabbits but not relevant for classification.