Registration Dossier
Registration Dossier
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EC number: 204-623-0 | CAS number: 123-38-6
Skin irritation / corrosion
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Propionaldehyde
- EC Number:
- 204-623-0
- EC Name:
- Propionaldehyde
- Cas Number:
- 123-38-6
- Molecular formula:
- C3H6O
- IUPAC Name:
- propanal
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
- Weight at study initiation: 3.21 kg for male and 3.80 kg for females
- Housing: single in cage made of stainless steel with wire mesh walk floors. Floor area: 40 cm x 51 cm
- Diet: Kliba 341, 4MM; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day); ad libitum
- Water: about 250 ml tap water per animal per day; ad libitum
- Acclimation period: at least 8 day (clipping of the fur at least 15 hours before the beginning of the study)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 4, 24, 48 and 72 hours
- Number of animals:
- 3 (one male 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: no data
- Type of wrap if used: test patches are secured in position with a porous dressing (4 layers of absorbent gauze + porous bandage).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol/water (1:1)
- Time after start of exposure: at the end of the exposure period
SCORING SYSTEM: OECD
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-48-72-hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: a slight erythema (1) was observed in 2 animals 30-60 min after treatment, but resolved within 24 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-48-72-hour
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- all irritation scores were 0 after 24, 48 and 72 hours
- Other effects:
- no other effects
Any other information on results incl. tables
No signs of irritation were observed in 2 additional groups for each 3 animals treated for 1 or 3 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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