Registration Dossier
Registration Dossier
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EC number: 221-022-9 | CAS number: 2976-74-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study had been performed in accordance with OECD Guideline No.: 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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
- Reference substance name:
- 2,3-dichlorophenoxyacetic acid
- EC Number:
- 221-022-9
- EC Name:
- 2,3-dichlorophenoxyacetic acid
- Cas Number:
- 2976-74-1
- Molecular formula:
- C8H6Cl2O3
- IUPAC Name:
- (2,3-dichlorophenoxy)acetic acid
- Details on test material:
- - Name of test material (as cited in study report): Dichlorophenoxyacetic acid
- Physical state: light beige powder
- Purity test date: 26. 09. 2005
- Lot/batch No.: 10
- Expiration date of the lot/batch: : 07. 2006
- Storage condition of test material: at room temperature, protected from light
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Ferenc Sándor, address: Császár street 135, Kartal, H-2173, Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: 2809-2835 g
at study termination: 2835-2936 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, PURISTAR standard diet for rabbits (produced by AGRIBRANDS Europe)
- Water (e.g. ad libitum): tap water (for human cosumption) from automatic self supplying watering system
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30± 70 %
- Photoperiod (hrs dark / hrs light): 12-12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
0.5 g of Dichlorophenoxyacetic acid was applied on the test site. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours (1, 24, 48 and 72 hours after the patch removal)
- Number of animals:
- 3 (male)
- Details on study design:
- TEST SITE
- Area of exposure: ~6 cm2
- Type of wrap if used: sterile gauze pads (5x5 cm) kept in contact with the skin by a patch of a surrounding adhesive hypoallergenic plaster.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the treatment perion the rest of the test item was removed with body temperature water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize (1959)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after the patch removal
- Score:
- 0 - 0.33
- Max. score:
- 0.33
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after the patch removal
- Score:
- 0
- Irritant / corrosive response data:
- One hour after the patch removal in two animals (No.: 04650, 04644) very slight erythema and in animal No.: 04621 moderate erythema and very slight oedema appeared on the treated skin surface.
24 hours after the patch removal only in one animal (No.: 04621) very slight erythema was found on the skin surface. The animals No.: 04650 and 04644 become fully symptom-free by this time.
48 hours after the patch removal no primary irritation symptoms, like erythema and oedema or other signs occurred on the treated skin surface.
72 hours after the treatment the study was terminated, since no primary irritation symptoms occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to EEC directive 2001/59/EEC, the test item DICHLOROPHENOXYACETIC ACID has not been classified as irritating for the skin.
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