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EC number: 207-256-4 | CAS number: 456-04-2
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, well documented with accepted restrictions (no GLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Short term test
- GLP compliance:
- no
Test material
- Reference substance name:
- α-chloro-4-fluoroacetophenone
- EC Number:
- 207-256-4
- EC Name:
- α-chloro-4-fluoroacetophenone
- Cas Number:
- 456-04-2
- Molecular formula:
- C8H6ClFO
- IUPAC Name:
- 2-chloro-1-(4-fluorophenyl)ethan-1-one
- Details on test material:
- - Name of test material (as cited in study report): omega-chlor-para-fluoracetophenon
- Physical state: not reported
- Analytical purity: 98 %, technical grade
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: no data
- Weight at study initiation: males 2.69 kg mean
- Housing: singly
- Diet: Kliba 341, about 130 g per animal/day
- Water: about 250 ml per animal per day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: fur clipped at least 15 h before application
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged test substance moistened with distilled water - Duration of treatment / exposure:
- 3 min and 1 h, respectively
- Observation period:
- 15 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on the upper third of the back or flanks
- Type of wrap if used: semiocclusive: porous dressing (four layers of absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: after 3 min and 1 hour, respectively
SCORING SYSTEM: Based on J.H. Draize: Appraisal of the safety of chemicals in foods, drugs and cosmetics. In Dermal Toxicity pp. 46 - 59, 1959. Austin, Tex.: Association of Food and Drug Officials of the United States, Texas, State Department of Health.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 1 h
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Erythema grade 2 and superficial scabbing after 15 d
- Irritation parameter:
- erythema score
- Remarks:
- 1 h
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Full thickness necrosis after 8 d
- Irritation parameter:
- erythema score
- Remarks:
- 1 h
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Superficial scabbing after 8 d, severe scaling after 15 d
- Irritation parameter:
- edema score
- Remarks:
- 1 h
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 15 days
- Remarks on result:
- other: Edema grade 2 and superficial scabbing after 15 d
- Irritation parameter:
- edema score
- Remarks:
- 1 h
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: Full thickness necrosis after 8 d,
- Irritation parameter:
- edema score
- Remarks:
- 1 h
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: Superficial scabbing beyond exposure area after 8 d, severe scaling after 15 d
- Irritation parameter:
- erythema score
- Remarks:
- 1 h
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: full thickness necrosis in 1 animal
- Irritation parameter:
- edema score
- Remarks:
- 1 h
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: full thickness necrosis in 1 animal
- Irritation parameter:
- erythema score
- Remarks:
- 3 min
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- erythema score
- Remarks:
- 3 min
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- 3 min
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- edema score
- Remarks:
- 3 min
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: Scaling after 8 d, abated completely by d 15
- Irritation parameter:
- edema score
- Remarks:
- 3 min
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: exposure
- Irritation parameter:
- edema score
- Remarks:
- 3 min
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- 3 min
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.4
- Irritation parameter:
- edema score
- Remarks:
- 3 min
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.6
- Reversibility:
- fully reversible within: 8 d
- Irritant / corrosive response data:
- 1-hour exposure:
Erythema and edema were extending beyond the area of exposure at 24, 48 and 72 h in all animals, animals 1 and 2 showed hemorrhages from 24 h to 72 hours, animal 3 from 48 to 72 h. Animal 2 developed a full thickness necrosis after 8 days and was killed, findings were confirmed by gross-pathological examination. Animal 3 showed superficial scabbing extending beyond the area of exposure after 8 days and severe scaling after 15 days.
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