Registration Dossier
Registration Dossier
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EC number: 416-900-5 | CAS number: 79723-02-7 TMAP
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1987-July 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles. Test substance only indicated by abbreviation; no information on test substance purity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- no information on test substance purity
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tetramethylammonium hydrogen phthalate
- EC Number:
- 416-900-5
- EC Name:
- Tetramethylammonium hydrogen phthalate
- Cas Number:
- 79723-02-7
- Molecular formula:
- C12H17NO4
- IUPAC Name:
- tetramethylazanium 2-carboxybenzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): TMAP
- Physical state: white crystalline powder
- Storage condition of test material: room temperature in sealed container
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.70 - 2.88 kg
- Housing: individually in suspended metal cages.
- Diet: ad libitum (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.)
- Water: Free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 65 - 68
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 18 June 1987 To: 21 June 1987
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze patch, secured with a strip of surgical adhesive tape (BLENDERM); the trunk of each rabbit was wrapped in an elasticated corset
(TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1,2,3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean score; one animal scored 1 at 1h after exposure
- Irritation parameter:
- edema score
- Basis:
- animal: #1,2,3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean score
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated skin site one hour after removal of the patches. No adverse skin reactions were noted at the remaining treated skin sites at this time or at any treated skin site at subsequent 24, 48 and 72- hour observations.
- Other effects:
- No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a skin irritation test in rabbits performed according to OECD guideline 404 and GLP principles, TMAP was found to be not irritating to rabbit skin.
- Executive summary:
A skin irritation test in rabbits was performed according to OECD guideline 404. Very slight erythema was noted at one treated skin site one hour after removal of the patches. No adverse skin reactions were noted at the remaining treated skin sites at this time or at any treated skin site at subsequent 24, 48 and 72- hour observations.
The test material produced a primary irritation index of 0.0 and was classified as non- irritant to rabbit skin.
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