Registration Dossier
Registration Dossier
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EC number: 273-227-8 | CAS number: 68953-84-4
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:
- other: GLP study performed in manner consistent with OECD & EPA guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.
- EC Number:
- 273-227-8
- EC Name:
- 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.
- Cas Number:
- 68953-84-4
- Molecular formula:
- C18-20H16-20N2
- IUPAC Name:
- Reaction mass of N-phenyl,N'-o-tolyl-phenylene diamine, N,N'-diphenyl-p-phenylene diamine and N,N'-di-o-tolyl-phenylene diamine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Adult test animals (all females) were received from Myrtle's Rabbitry, Tennessee, and weighed 2.1 to 2.5 kg. A five day quarantine was imposed prior to test initiation. Animals were maintained in room at 68-72 degrees F with 38-48% humidity, 12 hr light/12hr dark photocycle. Rabbits were fed Purina Rabbit Chow ad libitum, and provided drinking water ad libitum tested for chemical contaminants.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- The test material was applied to one site per animal in 0.5 gram amounts under a 1-inch square patch of moistened (with 0.5 ml water) gauze. Neck collars were affixed to prevent animals' interference with dermal test sites. These collars were in place for the full 72 hr test period.
- Duration of treatment / exposure:
- Gauze patches remained at test sites for period of 4 hrs. At that time, excess test material was removed by swabbing each site with moistened gauze.
- Observation period:
- Observations at chemical application sites at 1, 24, 48, & 72 hr after patch removal from dermal sites.
- Number of animals:
- Six females were used as test animals.
- Details on study design:
- Test chemical was applied to the dorsal area of the animal, one site (1-inch square) per rabbit. The binding was an elastic wrap covering the gauze patch.
The scoring system used was based upon Draize method. Animals were observed for clinical signs of intoxication.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 hr period
- Score:
- ca. 0.23
- Max. score:
- 0.37
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hr period
- Score:
- ca. 0.46
- Max. score:
- 0.75
- Reversibility:
- fully reversible within: 72 hr
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hr period
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight erythema (score of 1 out of 4) seen in 5 of 6 rabbits.
Any other information on results incl. tables
No animals exhibited edema during 72 hr study.
Slight erythema (grade 1 of 4) was observed in 5/6 rabbits at 1 hr, 3/6 at 24 & 48 hrs, and 0/6 at 72 hrs.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Primary Irritation Index
- Conclusions:
- According to criteria established for Primary Irritation Index, the chemical is rated "slight irritant".
- Executive summary:
The test chemical was subjected to a dermal irritation assessment consistent with methods described by OECD and EPA. Following application of undissolved test chemical to rabbit skin sites for a period of 4 hrs, scoring for signs of irritation were made at 1, 24, 48, & 72 hrs following removal of residual chemical. Only signs of slight erythema were observed. According to criteria established for Primary Irritation Index, the chemical is rated "slight irritant".
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