Registration Dossier
Registration Dossier
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EC number: 209-077-7 | CAS number: 554-95-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Consumer Product Safety Commision USA (Code of Federal Regulations, Title 16, Section 1500.41)
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzene-1,3,5-tricarboxylic acid
- EC Number:
- 209-077-7
- EC Name:
- Benzene-1,3,5-tricarboxylic acid
- Cas Number:
- 554-95-0
- Molecular formula:
- C9H6O6
- IUPAC Name:
- benzene-1,3,5-tricarboxylic acid
- Test material form:
- solid
- Details on test material:
- Benzene-1,3,5-tricarboxylic acid manufactured by Chemische Werke Hüls AG Marl (1980)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: White New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: White New Zealand
- Sex: male and female
- Source: J. Scheele, Büderich (Germany)
- Number of animals: 3 males, 3 females
ENVIRONMENTAL CONDITIONS
- Feed: Ssniff K 4 (Ssniff, Soest; Germany)
- Water: tap water ad libitum
- Room temperature: 20°C (+/- 1°C)
- Illumination: 12 hour light/dark rhythm
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- ADMINISTRATION/EXPOSURE
- Vehicle: none
- Total volume applied: 0.5 ml - Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- Postexposure period: 72 hours
- Number of animals:
- 3 per sex
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Area of exposure: 6 cm²
- Occlusion: mull patch, polyethylene film, impervious material (such as rubberized cloth)
- Removal of test substance: after 24 hours, no rinsing
- Postexposure period: 72 hours
EXAMINATIONS
- Scoring system: according to Draize
- Examination time points: 24 and 72 hours after administration of the test substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 72 h
- Score:
- 0
- Max. score:
- 8
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0
- Irritation index: 0 - Other effects:
- no other effects
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions, none of the six rabbits exposed for 24 hours to 0.5 mL test item/patch showed any skin reaction.
- Executive summary:
The purpose of this study was to examine the test item for acute dermal irritation/corrosion properties in rabbits (patch test).
In a primary skin irritation test with three male and three female rabbits test item applied with occlusive dressing to the shaved and scarified back skin at a dose level of 0.5 mL per animal for 24 h. Residual test substance was not rinsed.
Skin reaction were scored according to ETAD Subcommitee for toxicology at 24h and 72h after application.
Under the present test conditions, none of the six rabbits exposed for 24 hours to 0.5 mL test item/patch showed any skin reaction.
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