Registration Dossier
Registration Dossier
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EC number: 203-247-4 | CAS number: 104-88-1
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:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch Test Rabbit - Code of Federal Regulations, Title 16, Section 1500.41
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-chlorobenzaldehyde
- EC Number:
- 203-247-4
- EC Name:
- 4-chlorobenzaldehyde
- Cas Number:
- 104-88-1
- Molecular formula:
- C7H5ClO
- IUPAC Name:
- 4-chlorobenzaldehyde
- Details on test material:
- -Name of the test material : p-Chlorobenzaldehyde, pure
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: W. OStrup / Meerbuch
- Weight at study initiation: average 2.4 kg
- Diet (ad libitum): mümmel z (ssniff / Soest)
- Water (ad libitum): yes
- Acclimation period: 7- 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved or shaved + scratched
- Vehicle:
- other: oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg in oil - Duration of treatment / exposure:
- 24 h
- Observation period:
- 8 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: 5 x 5 cm impermeable foil (PVC) + Eloflex tape
SCORING SYSTEM:
- according to Draize
Scores for erythema and edema fr intact and scratched skin after 24 and 72 hours were averaged.
The resultig means divided by 4 result in the primary irritating index fot the skin..
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- (intact and scratched skin of 6 animals)
- Time point:
- other: 24 h and 72 h
- Score:
- 5.2
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: classified as highly irritating
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: Score after 48 h not available
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- other: Score after 48 h not available
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Executive summary:
In a dermal irritation study (FhG 1980) six New Zealand White rabbits were dermally exposed to undiluted p-Chlorobenzaldehyde in oil. The test site (intact or scratched dorsal skin) was covered with an occlusive dressing for 24 hours. Rabbits then were observed for 8 days. Irritations regarding erythema and edema were scored according to the Draize system after 24 and 72 hours. The test item p-Chlorbenzaldehyde exhibited a highly irritating potential in this study (after 24 h exposure with occlusive conditions), but it seems to be unlikely that the substance would be corrosive after a 4 h semiocclusive treatment according to OECD Guideline 404.
Primary dermal irritation index (6 animals): 5.2 (highly irritating)
The substabce is classified as Skin Irrit. Cat. 2 according to GHS.
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