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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
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Short term test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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