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Toxicological information

Skin irritation / corrosion

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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:
2003
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

Constituent 1
Chemical structure
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)

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).