Registration Dossier
Registration Dossier
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EC number: 212-832-3 | CAS number: 872-85-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 May - 7 June 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Isonicotinaldehyde
- EC Number:
- 212-832-3
- EC Name:
- Isonicotinaldehyde
- Cas Number:
- 872-85-5
- Molecular formula:
- C6H5NO
- IUPAC Name:
- pyridine-4-carbaldehyde
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report) : Pyridin-4-aldehyd
- Physical state : liquid
- Analytical purity : minimum 98% (GC)
- Lot/batch No. : 05394
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source : Kleintierfarm Madoerin AG , 4414 Fuellinsdorf , Switzerland
- Age at study initiation : 12 weeks
- Weight at study initiation : 2,5 - 2,7 kg
- Housing : The animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet : rabbit maintenance diet (pelleted standard Kliba 341 , Klingentalmühle AG , 4303 Kaiseraugst , Switzerland) , ad libitum
- Water : tap water , ad libitum
- Acclimation period : 4 days
ENVIRONMENTAL CONDITIONS
- Temperature : 22°C +/- 2°C
- Humidity : 55% +/- 10%
- Air changes (per hr) : no data
- Photoperiod (hrs dark / hrs light) : 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit) : 0,5 g of the undiluted test substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 (1 male , 2 females)
- Details on study design:
- TEST SITE
- Area of exposure : Application was made to one intact skin site on the clipped dorsum ( 3,0 x 3,0 cm) of each rabbit .
- Type of wrap if used : The test article was applied under a patch of surgical gauze approximately 3,0 x 3,0 cm . When the patch was in place , it was covered with impermeable material and fastened to the body with adhesive tape .
REMOVAL OF TEST SUBSTANCE
- Washing (if done) : no data
SCORING SYSTEM : Draize scoring system . The test sites were examined 24 , 48 , 72 hours and 7 days after removing bandages and gauze patch .
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 24h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 48h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 72h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 7 days
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 24h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 48h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 72h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 7 days
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- Irritation : Pyridin-4-aldehyd showed a moderate irritation , when applied to intact rabbit skin .
Corrosion : In 2 rabbits destructions of the treated skin were observed after 7 observation days . - Other effects:
- In the area of application a yellowish discoloration of the skin was observed which could be related to effects of the test article
Any other information on results incl. tables
Individual Findings :
Animal No. 301 , male
| After 1 hour | Due to the aggressive vapour phase , no detailed observations were performed |
| After 24 hours | Application area : swelling , distinct, shiftable in abdominal direction; yellowish discoloration, slight |
| After 48 hours | Application area : swelling, slight hardly visible; slight redness; yellowish discoloration, slight |
| After 72 hours | Application area : slight redness |
| After 7 days | Application area : redness, severe, partly; swelling, slight; yellowish discoloration |
Animal No. 302 , female
| After 1 hour | Due to the aggressive vapour phase , no detailed observations were performed |
| After 24 hours | Application area : swelling , slight, with light foci; yellowish discoloration, slight |
| After 48 hours | Application area : redness, slight, well defined, light foci; yellowish discoloration, slight |
| After 72 hours | Application area : redness, slight, well defined, light foci; yellowish discoloration, slight |
| After 7 days | Application area : well defined, yellow to brown discoloration |
Animal No. 303 , female
| After 1 hour | Due to the aggressive vapour phase , no detailed observations were performed |
| After 24 hours | Application area : swelling , clearly visible; 1/4 necrosis, black; remaining areas red,slight; yellowish discoloration, slight |
| After 48 hours | Application area : 1/4 necrosis, deep, black; marginal area red, swollen, well defined |
| After 72 hours | Application area : 1/4 necrosis, deep, black; marginal area red, swollen, well defined |
| After 7 days | Application area : 1/4 necrosis, deep, black; marginal area red, swollen, well defined |
Body weight : The body weight gain of all rabbits was similar
Toxic symptoms : Staring with day 2 of the observation , rabbit No. 302 refused feed . According to this body weight loss , curved body position , diarrhoe and sedation was observed during the study . Just after the observation at test-day 8 , the animal died spontaneously . (Macroscopic findings : stomach : fundus, focal bleedings ; colon : reddened )
Necropsy : Due to the results obtained , no macroscopic organ examination of the surviving rabbits was indicated .
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The study was performed according to the OECD Guideline 404 with no deviations and according to the good laboratory practice principles, it is considered to be of highest quality (reliability Klimisch 1). The criteria of validity of the test system are fulfilled. Under the conditions of this experiment , Pyridin-4-aldehyd was found to cause a moderate irritation when applied to intact rabbit skin .
- Executive summary:
The skin irritation potential of the test substance was investigated in New Zealand White rabbits according to OECD TG404. The test substance was applied occlusively to the intact skin for 4 hours; thereafter the skin reactions were monitored for 7 days. Under the conditions of this experiment the test material was found to cause a moderate irritation. In the area of application a yellowish discoloration of the skin was observed in the rabbits at all measuring intervals. In 2 rabbits, a corrosion effect had occurred on the skin after 7 observations days. The body weight gain of all rabbits was similar. Starting with day two of the observation, rabbit No. 302 re-fused feed. According to this body weight loss, curved bodyposition, diarrhoe and sedation was observed during the study. Just after the observation at test-day 8, the animal died spontaneously. Macroscopic findings:
- Stomach: fundus, focal bleedings.
- Colon: reddened.
The calculated primary irritation index was found to be 3.1 (Mean irritation index for intact skin).
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