Registration Dossier
Registration Dossier
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EC number: 204-605-2 | CAS number: 123-15-9
Skin irritation / corrosion
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:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- 2-methylvaleraldehyde
- EC Number:
- 204-605-2
- EC Name:
- 2-methylvaleraldehyde
- Cas Number:
- 123-15-9
- Molecular formula:
- C6H12O
- IUPAC Name:
- 2-methylpentanal
- Details on test material:
- - Name of test material: 2-METHYLPENTANAL
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system 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
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