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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
Study period:
14 Sep - 28 Sep 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Adopted in 1992
Deviations:
yes
Remarks:
Mean temperature and relative humidity values in the animal room slightly exceeded the current guideline values. These deviations do not affect the final outcome of the study.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
448-100-7
EC Name:
-
Cas Number:
70441-63-3
Molecular formula:
C9H12FN
IUPAC Name:
4-fluoro-N-(propan-2-yl)aniline
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult, not further specified
- Body weight: 3.6, 4.0, and 3.2 kg
- Housing: Rabbits were individually housed in stainless steel cages with flat rod bases or plastic cages with perforated bases. Excrement trays beneath the cages contained low-dust (wood) bedding (type S 8/15, Ssniff Spezialdiäten GmbH, Soest, Germany).
- Diet: standard diet Ssniff K4 (Ssniff Spezialdiäten GmbH, Soest, Germany), approx. 100 - 120 g/animal/day; once per day in the morning.
- Water: tap water of drinking-water quality, ad libitum.
- Acclimation period: two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23
- Humidity (%): 60 - 80
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 Sep 1993 To: 28 Sep 1993

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 µL
- Concentration (if solution): undiluted, pure test substance
Duration of treatment / exposure:
4 h
Observation period:
1 h, 24 h, 48 h, 72 h, 7 days and 14 days after removal of the patch; observation period till study termination was 14 days
Number of animals:
3 female animals
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: 500 µL of the test substance were applied to a hypoallergenic Hansamed®-patch. The treated skin area was approx. 6 cm² in size.
- Type of wrap if used: semiocclusive dressing (Fixomull®-Stretch Klebevlies (adhesive fleece), Beiersdorf no. 2293)

REMOVAL OF TEST SUBSTANCE
- Washing: After an exposure period of four hours, the dressing and patches were removed. The exposed skin areas were carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 h, 24 h, 48 h, 72 h, 7 days and 14 days after removal of the patch

SCORING SYSTEM
DRAIZE
Erythema and eschar formation:
0 = no erythema
1 = very slight erythema (barely perceptible)
2 = well-defined erythema
3 = moderate to severe erythema
4 = severe erythema (4R) to slight eschar formation (4S) (injuries in depth)
Edema formation:
0 = no edema
1 = very slight edema (barely perceptible)
2 = slight edema (edges of area well defined by definite raising)
3 = moderate edema (raised approx. 1 mm)
4 = severe oedema (raised more than 1 mm and extending beyond area of exposure)

Any serious lesions or toxic effects other than dermal irritation were also recorded and fully described.

- Method of calculation: For each animal the DRAIZE scores recorded approx. 24, 48, and 72 hours after application were added up. The total of these three values was divided by three to give the irritation index. This index was separately calculated for erythema/eschar formation and for edema formation. Where three animals were used, interpretation was based on the individual indices obtained from the two most sensitive animals. Where more than three animals were used, the mean irritation index was calculated by averaging the total scores of all rabbits tested. If delayed reactions occurred, or where no irritation indices could be calculated (e. g. due to coloration by the test substance) other interpretation criteria were applied.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Exposure of the test substance to the skin resulted in erythematous and exsudative reactions in all three animals; signs did not prove to be reversible up to day 14. These results indicate that the test substance is irritating to the skin.
Seven days post exposure a white squamous coat appeared on the treated skin.

Any other information on results incl. tables

Table 1. Results of dermal irritation/corrosion testing with female New Zealand White rabbits exposed for 4 hours to N-Isopropyl-4-fluoroaniline

Animal no. Body weight (kg) Draize grade after
1 h 24 h 48 h 72 h 7 d 14 d
e o e o e o e o e o e o
1 3.6 1 0 2 2 1 1 1 1 1 1f 2 0
2 4.0 2 2 2 1 3 1 2 0 2 1 2 0f
3 3.2 2 2 2 2 3 1 2 0 1 0f 1 0

e = erythema and eschar formation

o = oedema formation

f = white squamous coat

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Exposure of the test substance to the skin resulted in erythematous and exsudative skin reactions in all three tested animals. Signs were not reversible up to study day 14.
The Draize scoring results and the missing of full reversibility provide evidence for the test substance to be irritating to skin, thus waranting classification and labeling as Cat 2 H315 according to GHS.