Registration Dossier
Registration Dossier
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EC number: 277-146-9 | CAS number: 72968-71-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- according to § 1500.41 in Federal Register Vol. 38, No. 187, S. 26019 ov 27.09.73
The procedure followed the standards of that time. - GLP compliance:
- no
Test material
- Reference substance name:
- Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate
- EC Number:
- 277-146-9
- EC Name:
- Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate
- Cas Number:
- 72968-71-9
- Molecular formula:
- C23H29N7O4S
- IUPAC Name:
- methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Name of test substance given in report: Thermoplastrot BS – Misch-Nr. 07-4264,
Composition given in report: 103,0 Teile Thermoplastrot Lm Fw/400 Stück ber. 100%
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- breeder: M. Gaukler, 6050 Offenbach
mean weight: about 3.0 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: pasted with 50% water
- Amount / concentration applied:
- about 0.5 g on a patch of about 2.5 x 2.5 cm
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 8 days after patch removal
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: about 2.5 x 2.5 cm
- Type of wrap if used: patch is covered with a rubberized linnen lobe, fixed and wrapped with a gauze bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
24 hours, 72 hours and 8 days after patch removal
SCORING SYSTEM:
- Method of calculation: scores of 1-4 for reddening and oedema
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-6
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- due to substance induced staining of the skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-6
- Time point:
- other: 72h and 8 days after patch removal
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 1-6
- Time point:
- other: 24h, 72 h and 8 days after patch removal
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Executive summary:
In a skin irritation study performed according to Fed. Reg. 38, no. 187, § 1500.41 (1973) 0.5g of the solid test item pasted with water was applied for 24 hours to the intact skin of the back of 6 rabbits. 24 hour after patch removal erythema could not be evaluated due to a distinct red/brown staining of the skin due to the coloured test item. 72 hours and 8 days after patch removal no indication of erythema was recorded. Oedema was not seen at all scoring times (24h, 72h, 8days). The test item thus did not show irritating effects to the skin of rabbits.
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