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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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:
1988
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

Constituent 1
Chemical structure
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

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.

Applicant's summary and conclusion