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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-04-02 to 2001-04-07
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 404 (Acute Dermal Irritation / Corrosion)
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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen.
- Age at study initiation:
- Weight at study initiation:
- Housing: semi-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 least 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated other side of the dorsal area served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 h
Observation period:
Animals were observed for 72 hours after dosing
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: no data
- Type of wrap if used: gauze patch, held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using water
- Time after start of exposure: 4 h

SCORING SYSTEM: see table 1 in "Any other information on materials and methods"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Other effects:
no other effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item TDI-Urone is not considered to be irritating.
Executive summary:

In a primary dermal irritation study according to OECD 404 three female New Zealand White Rabbits Crl:KBL (NZW) BR. were dermally exposed to 0.5 g of TDI-Urone for 4 hours to approximate 6 cm² of the skin on one side of the dorsal area. Animals then were observed for 3 days. The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period. Therefore, TDI-Urone is not irritating to the skin.