Registration Dossier
Registration Dossier
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EC number: 220-864-4 | CAS number: 2921-88-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Primary Dermal Irritation Study, 1985
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Chlorpyrifos
- EC Number:
- 220-864-4
- EC Name:
- Chlorpyrifos
- Cas Number:
- 2921-88-2
- Molecular formula:
- C9H11Cl3NO3PS
- IUPAC Name:
- O,O-diethyl O-3,5,6-trichloropyridin-2-yl phosphorothioate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Substance ID: TSN100759
Lot Number: 7299412
Purity: 97.6%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Kalamazoo, Michigan
- Age at study initiation: Approximately 4 months
- Weight at study initiation: 2.044-2.598 kg
- Housing: Housed individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: At least 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 3
- Humidity (%): 40-60
- Air changes (per hr): 15
- 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: 0.5 mL (The crystalline test substance was gently heated to achieve a liquid state)
- Concentration: Neat - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes, and 24, 48 and 72 hours
- Number of animals:
- Three male and three female animals
- Details on study design:
- TEST SITE
- Area of exposure: 10 x 10 cm
- Type of wrap if used: Elastic rabbit jacket
REMOVAL OF TEST SUBSTANCE
- Washing: The back was wiped with a damp disposable towel to remove any residual test substance
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30 minutes, and 24, 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight erythema was present at the application site of all rabbits, and very slight edema was present at the application site of two rabbits, within 30 minutes after the four-hour exposure. One additional rabbit had very slight edema at the application site 24 hours after exposure. The erythema and edema resolved in all rabbits by 7 days after test material removal, and the test was then terminated.
- Other effects:
- Dermal application of 0.5 ml of the test subtance had no effect on body weight.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating in rabbits
- Executive summary:
The study was conducted following OECD guideline 404 and EPA guideline 81-5. The test substance was evaluated for primary dermal irritation. Aliquots of 0.5 ml of neat test substance were applied for four hours to the intact skin on the back of six New Zealand White rabbits.
Very slight erythema was present at the application site of all rabbits, and very slight edema was present at the application site of two rabbits, within 30 minutes after the four hour exposure. One additional rabbit had very slight edema at the application site 24 hours after exposure. The erythema and edema resolved in all rabbits by 7 days after test material removal, and the test was then terminated. Body weights were not affected.
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