Registration Dossier
Registration Dossier
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EC number: 944-086-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The material was additionally tested on scarified skin; 6 animals employed
- GLP compliance:
- no
- Remarks:
- pre-dates GLP regulation
Test material
- Reference substance name:
- Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
- EC Number:
- 249-352-9
- EC Name:
- Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
- Cas Number:
- 28983-56-4
- Molecular formula:
- C37H29N3O9S3.2Na
- IUPAC Name:
- Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- SPF-Albino-Himalayan-Rabbit; Strain: Hoe:HIMK(SPF Wiga)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped or clipped and abraded
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- 500 mg/site
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- Six rabbits of 1,5 to 2 kg bw were used. The material was secure by adhesive tape to the clipped or clipped and abrades skin site on the flanks of the animals for 24 hours under an occlusive wrap. Application site were 2,5 x 2,5 cm².
Findings were evaluated immediately after removal of the patches as well as 48 and 72 hours after start of exposure. The irritation index was calculated according to § 1500 . 41 Federal Register 38, No. 187, 27. 9. 1973 , p 27019
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.9
- Max. score:
- 8
- Reversibility:
- not specified
- Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The overal irritation index was determined as 0.9 according to § 1500. 41 Federal Register 38, No. 187 , 27 . 9. 1973 , p 27019
- Executive summary:
The test item was applied to the clipped or clipped and abraded skin of 6 rabbits for 24 hours under occlusive conditions. Findings were evaluated 24, 48 and 72 hours after start of exposure.
The overal irritation index was determined as 0.9 according to § 1500. 41 Federal Register 38, No. 187 , 27 . 9. 1973 , p 27019
The material did not meet the criteria for classification accordimg to GHS.
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