Registration Dossier
Registration Dossier
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EC number: 229-186-3 | CAS number: 6424-76-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.41
- GLP compliance:
- no
Test material
- Reference substance name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- EC Number:
- 229-186-3
- EC Name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- Cas Number:
- 6424-76-6
- Molecular formula:
- C36H18O4
- IUPAC Name:
- 17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- Vat Blue 16
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3 to 4 kg
- Housing: single
- Diet (ad libitum): standard pellet
- Water (ad libitum): tap
- Acclimation period: > 3 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- right flank additionally scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 d
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Preparation: about 2 to 16 h before the start of the study the skin on the back of 6 rabbits was clipped on both sides of the body on an area of approximately 6.25 x 6.25 cm using electric clippers. The skin on the right side at the test patch application site was additionally scarified using a scalpel.
- Area of exposure: 2.5 x 2.5 cm, covered with medical gauze and indifferent, impermeable PVC foils (5 x 5 cm)
- Type of wrap if used: Eloflex as elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours with water or Lutrol 400/water
SCORING SYSTEM: according to the score of Draize
After 7 days, evaluation of the subcutis and the muscles below at necropsy
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- clipped skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- clipped skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- clipped skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- clipped skin
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h + 72 h
- Score:
- 0.88
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Remarks:
- clipped and scarified skin
- Irritant / corrosive response data:
- No signs of systemic toxicity were observed during the observation period
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the experimental conditions the test item is detemined to be not irritating to the skin.
- Executive summary:
In the primary skin irritation test according to the Code of Federal Regulations, Title 16, Section 1500.41 the test item produced a primary irritation score of about 0.88 in intact scarified skin, leading to the conclusion of "not irritant". The main effects in erythema and edema formation was seen in scarified skin, the intact skin did not show signs of irritation. No effects were seen at necropsy in the subcutis. According to GHS classification, the test substance is not irritating to skin.
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