Registration Dossier
Registration Dossier
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EC number: 601-779-5 | CAS number: 121451-02-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 August 1999 - 20 August 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Primary Dermal Irritation Study, 1985
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- EC Number:
- 601-779-5
- Cas Number:
- 121451-02-3
- Molecular formula:
- C17H7Cl2F9N2O3
- IUPAC Name:
- 1-[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]-3-(2,6-difluorobenzoyl)urea
- Test material form:
- solid
- Details on test material:
- - Substance type: White solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.2 - 2.4 kg
- Diet: 5 ounces of pelleted rodent feed per day.
- Water: Municipal water was provided ad libitum
- Acclimation period: for at least two weeks prior to study start.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3 °C
- Humidity (%):40 – 60 %
- Air changes (per hr): 12-15 times/hour.
- Photoperiod (hrs dark / hrs light): 12-hour light/dark photocycle, lights on at 6:00 a.m. and off at 6:00 p.m.
IN-LIFE DATES: From: 01/05/1999 To: 20/08/1999
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 0.5 % methylcellulose
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g (neat test material)
VEHICLE
- Amount applied: 0.7 mL
- Concentration: 0.5 % methylcellulose - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Three rabbits, two males and one female.
- Details on study design:
- TEST SITE
- Area of exposure: An area approximately 10 cm x 10 cm of the back of each rabbit.
- Type of wrap if use: The test site was covered with a gauze patch (approximately 6 cm²) with cotton backing. The gauze patch was held in place with an elastic rabbit jacket.
REMOVAL OF TEST SUBSTANCE
- Washing: The back of each rabbit was wiped with a damp disposable towel to remove any residual test substance.
- Time after start of exposure: 4 hours.
SCORING SYSTEM
The application sites were graded for erythema and oedema within thirty minutes, and 24, 48 and 72 hours after test material removal.
BODY WEIGHTS
Animals were weighed on the day of treatment, and at study termination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 99A3936
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 99A3937
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 99A3938
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 99A3936
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 99A3937
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 99A3938
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- There was no irritation observed in any of the three rabbits, see Table 2.
- Other effects:
- No systemic toxicity was observed.
No effect on body weight was observed.
Any other information on results incl. tables
Table 2: Individual Irritation Scores
Observation Time – Time After Removal |
Animal Number |
Erythema |
Edema |
Within 40 minutes |
99A3936 |
0 |
0 |
99A3937 |
0 |
0 |
|
99A3938 |
0 |
0 |
|
24 hours |
99A3936 |
0 |
0 |
99A3937 |
0 |
0 |
|
99A3938 |
0 |
0 |
|
48 hours |
99A3936 |
0 |
0 |
99A3937 |
0 |
0 |
|
99A3938 |
0 |
0 |
|
72 hours |
99A3936 |
0 |
0 |
99A3937 |
0 |
0 |
|
99A3938 |
0 |
0 |
Table 3: Individual Body Weights
Animal Number |
Body Weight (kg) |
|
Test Day 1 |
Test Day 2 |
|
99A3936 |
2.389 |
2.445 |
99A3937 |
2.348 |
2.397 |
99A3938 |
2.185 |
2.197 |
Note: Animals 99A3936 and 99A3937 were males, 99A3938 was female.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, application of the test material resulted in no irritation in any of the rabbits, and had no effect on body weights.
- Executive summary:
The acute dermal irritation potential of the test material was determined in a GLP study conducted in accordance with the standardised guidelines OECD 404, EPA OPPTS 870.2500, EU Method B.4, and Japan MAFF Primary Dermal Irritation Study, 1985.
Aliquots of 0.5 g of the neat test material, moistened with 0.7 mL of 0.5 % methylcellulose, were applied for four hours to the intact skin on the back of three New Zealand White rabbits.
Under the conditions of the test, application of the test material resulted in no irritation in any of the rabbits, and had no effect on body weights.
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