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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
Study period:
1989 - 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study according to OECD TG 404 (adopted May 12th, 1981) without GLP compliance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted May 12th, 1981)
Deviations:
no
GLP compliance:
yes
Remarks:
(storage of the report and raw data is noticed)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 2-METHYLPENTANAL

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; D-6050 OFFENBACH/MAIN, FRG
- Age at study initiation: no data
- Weight at study initiation: 2.67 kg (male rabbit), 2.48 kg (females)
- Housing: CAGE MADE OF STAINLESS STEEL WITH WIRE MESH WALK FLOORS, FLOOR AREA: 40 CM X 51 CM, 1 Animal/cage
- Diet: KLIBA 341, 4 MM; FIRMA KLINGENTALMUEHLE AG, CH-4303 KAISERAUGST, SWITZERLAND (ABOUT 130 G PER ANIMAL PER DAV)
- Water: ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Acclimation period: AT LEAST 8 DAYS BEFORE THE BEGINNING OF THE STUDY; SAME HOUSING CONDITIONS AS DURING THE STUDY

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 DEGREES CELSIUS
- Humidity: 30 - 70 %
- Rooms: FULLY AIR-CONDITIONED
- Photoperiod (hrs dark / hrs light): 12 H/12 H

IN-LIFE DATES: From: 1989-11-13 To: 1989-12-07

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: APPLICATION 0F 0.5 ML 0F THE UNDILUTED TEST SUBSTANCE TO THE TEST PATCH (2.5 CM x 2.5 CM)

Duration of treatment / exposure:
4 h
Observation period:
15 days
Number of animals:
1 M, 2 F
Details on study design:
TEST SITE
- Area of exposure: 2.5 CM X 2.5 CM (UPPER THIRD OF THE BACK OR FLANKS)
- % coverage: < 10
- Type of wrap if used: POROUS DRESSING (FOUR LAYERS OF ABSORBENT GAUZE + POROUS BANDAGE).

REMOVAL OF TEST SUBSTANCE
- Washing: WITH LUTROL AND LUTROL/WATER (1:1)
- Time after start of exposure: AT THE END OF THE EXPOSURE PERIOD

SCORING SYSTEM: CALCULATION OF THE MEAN ACCORDING TO 83/467/EEC CRITERIA OF JULY 29TH, 1983
- Readings: 30 - 60 MINUTES AFTER REMOVAL OF THE TEST PATCHES AND 24 H, 48 H, 72 H, 8 D, 15 D AFTER THE BEGINNING OF APPLICATION
- Negative Conrol: UNTREATED SKIN SITES OF THE SAME ANIMAL

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h (compendious data)
Score:
2.9
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h (compendious data)
Score:
2
Max. score:
4
Irritant / corrosive response data:
Animal 1 and 2: Scaling was observed at the end of the observation period (first noticed on day 8)
Animal 3: Severe scaling was observed at the end of the observation period (first noticed on day 8)

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU