Registration Dossier
Registration Dossier
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EC number: 201-956-3 | CAS number: 89-98-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 18 SEP 2003 to 24 OCT 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 404)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-chlorobenzaldehyde
- EC Number:
- 201-956-3
- EC Name:
- 2-chlorobenzaldehyde
- Cas Number:
- 89-98-5
- Molecular formula:
- C7H5ClO
- IUPAC Name:
- 2-chlorobenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): 2-Chlorbenzaldehyde (OCAD)
- Substance type: transparent
- Physical state: liquid
- Storage condition of test material: room temperature, away from light, airtight (nitrogen purge)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd., Nagano, Japan (Producer, but purchased from Oriental Bioservice Kanto, Inc., Ibaraki, Japan)
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 1.98 to 2.27 kg
- Housing: individually housed in in aluminium, automatic water-washing cages for rabbits
- Diet: pelleted feed for experimental animals Cr-3 (Clea Japan, Inc., Tokyo, Japan), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10 times or more
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 30 SEP 2003 To: 15 OCT 2003
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/application site - Duration of treatment / exposure:
- 4
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x2.5 cm² (6.25 cm²)
- Type of wrap if used: lint patch, occluded with adhesive elastic bandage and surgical tape wrapped around the trunk
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after patch removal with Japanese pharmacopoeia water for injection
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- : individual scores (animal #1/#2/#3; mean) 1.67/2.3/4
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 d
- Remarks on result:
- other: scar formation was observed in one animal
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: scar formation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- : individual scores (animal #1/#2/#3; mean) 1.67/2/2
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- other: scar formation
- Irritant / corrosive response data:
- Results of 4 hour occlusive exposure (score: #1/#2/#3):
- 1 hour after patch removal: no erythema occurred, but edema was already visible (score: 1/2/3). In animal #3 there was a brown macule obvious at that time, too.
- 24 h reading: eyrthema (score: 1/2/4), edema (1/2/2)
- 48 h reading: eyrthema (score: 2/2/4), edema (2/2/2)
- 72 h reading: eyrthema (score: 2/3/4), edema (2/2/2)
- day 4: eyrthema (score: 2/3/4), edema (2/2/1)
- day 5: eyrthema (score: 2/4/4), edema (1/1/0)
- day 7: eyrthema (score: 1/4/4), edema (0/0/0). In one animal (#1) exafoliation of the skin was visible.
- day 10: eyrthema (score: 0/1/1), edema (0/0/0). In two animals (#1/#2) exafoliation of the skin was visible and in animal #3 proceeded to subcutaneous hemorrhage, necrosis of the skin and scar formation.
- day 14: eyrthema (score: 0/0/0), edema (0/0/0). No effects were seen in animals #1 and #2, but in animal #3 the scar remained. - Other effects:
- no other clinical signs occurred
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- Under the conditions used in this guideline study (OECD TG 404) the test item (2-chlorobenzaldehyde) was corrosive to the skin.
- Executive summary:
3 Japanes white rabbits were subjected to test the acute irritation/corrosion potential of the test item (2-chlorobenzaldehyde). According to OECD TG 404 0.5 mL of the indiluted test item were applied onto a lint patch and held at the skin under occlusive conditions for 4 hours. At the relevant readings for classification the test item revealed barely perceptible to severe erythema with slight eschar formation (mean erythema score: 2.67) and very slight to slight edema formation (mean edema score: 1.89). At the end of the observation period two animals were without any dermal reactions, but one animal still had positive dermal reactions, it showed subcutaneous hemorrhage (day 10), eschar formation (day 10) and scar formation (until day 14), which was considered to be a result of necrosis of the skin.
This well performed study which is in accordance with existing guidelines has been selected as key study (RL1).
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