Registration Dossier
Registration Dossier
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EC number: 214-333-6 | CAS number: 1121-60-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 November - 12 December 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
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:
- Pyridine-2-carbaldehyde
- EC Number:
- 214-333-6
- EC Name:
- Pyridine-2-carbaldehyde
- Cas Number:
- 1121-60-4
- Molecular formula:
- C6H5NO
- IUPAC Name:
- pyridine-2-carbaldehyde
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Pyridine-2-aldehyde
- Physical state: light yellow liquid
- Storage condition of test material: room temperature , in the dark until 31 July 2001 , thereafter approximately 4°C , under nitrogen , in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source : David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation : 12-16 weeks
- Weight at study initiation : 2.60-2,69 kg
- Housing : animals were individually housed in suspended metal cages
- Diet : STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK , ad libitum
- Water : main drinking water , ad libitum
- Acclimation period : 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C) : 16-21°C
- Humidity (%): 46-66%
- Air changes (per hr) : 15
- Photoperiod (hrs dark / hrs light) : 12/12
Test system
- Type of coverage:
- semiocclusive
- 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 ml - Duration of treatment / exposure:
- 3 min / 1 hour / 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure : 6,25 cm2
- Type of wrap if used : One rabbit was initially treated. Three suitable test sites were selected on the back of the rabbit. At each test site a quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset (TUBIGRIP). One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. After consideration of the skin reactions produced in the first animal, two additional animals were treated in a similar manner to the first treated animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done) : Residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
OBSERVATION TIME POINTS
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation
Any other skin reactions, if present, were also recorded. Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions.
SCORING SYSTEM : Draize scoring system .
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema .................................................................................................................. 0
Very slight erythema (barely perceptible)..................................................................... 1
Well-defined erythema.................................................................................................. 2
Moderate to severe erythema ........................................................................................ 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ............. 4
Oedema Formation Value
No oedema..................................................................................................................... 0
Very slight oedema (barely perceptible) ....................................................................... 1
Slight oedema (edges of area well-defined by definite raising).................................... 2
Moderate oedema (raised approximately 1 millimetre) ................................................ 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of
exposure) ....................................................................................................................... 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 24 h
- Score:
- 3.3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 48 h
- Score:
- 3.3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 72 h
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 7 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 14 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 24 h
- Score:
- 2.7
- Max. score:
- 3
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 72 h
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 7 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 4-hour exposure period)
- Time point:
- 14 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 24 h
- Score:
- 3.3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 48 h
- Score:
- 3.3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 72 h
- Score:
- 3.3
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 7 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 14 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 24 h
- Score:
- 2.3
- Max. score:
- 3
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 48 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 7 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 1-hour exposure period)
- Time point:
- 14 d
- Remarks on result:
- other: adverse skin reactions prevented accurate evaluation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 3-minute exposure period)
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 3-minute exposure period)
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 3-minute exposure period)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 3-minute exposure period)
- Time point:
- other: 7/14 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (of all 3 animals / 3-minute exposure period)
- Time point:
- other: 24/48/72 h , 7/14 d
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test material produced a modified primary irritation index of 6.7 based on the degree of erythema/injuries in depth following a 4-hour exposure and was classified as corrosive to rabbit skin
- Other effects:
- A single 4-hour, semi-occluded application of the test material to the Intact skin of three rabbits produced reactions indicative of dermal corrosion at two treated skin sites. The reactions included green-coloured dermal necrosis, severe oedema, a hardened dark brown/black coloured scab and scar tissue. Well-defined erythema, slight oedema, crust formation and slight desquamation were noted at one other treated skin site.
A single 1-hour, semi-occluded application of the test material to the intact skin of three rabbits produced reactions indicative of dermal corrosion at two treated skin sites. The reactions included greencoloured dermal necrosis, severe oedema, a hardened dark brown/black coloured scab and scar tissue. Well-defined erythema, slight oedema, crust formation and slight desquamation were noted at one other treated skin site.
A single, 3-minute, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema, very slight oedema and slight
desquamation. All treated skin sites appeared normal at the 14-day observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test material, 2-ALDEHYDEPYRIDINE, produced a modified primary irritation index of 6.7 based on the degree of erythema/injuries in depth following a 4-hour exposure period and was classified as a CORROSIVE to rabbit skin.
- Executive summary:
A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion" (adopted ‘I7 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
A single 4-hour, semi-occluded application of the test material to the Intact skin of three rabbits produced reactions indicative of dermal corrosion at two treated skin sites. The reactions included green-coloured dermal necrosis, severe oedema, a hardened dark brown/black coloured scab and scar tissue. Well-defined erythema, slight oedema, crust formation and slight desquamation were noted at one other treated skin site.
A single 1-hour, semi-occluded application of the test material to the intact skin of three rabbits produced reactions indicative of dermal corrosion at two treated skin sites. The reactions included greencoloured dermal necrosis, severe oedema, a hardened dark brown/black coloured scab and scar tissue. Well-defined erythema, slight oedema, crust formation and slight desquamation were noted at one other treated skin site.
A single, 3-minute, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema, very slight oedema and slight
desquamation. All treated skin sites appeared normal at the 14-day observation.
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