Registration Dossier
Registration Dossier
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EC number: 224-403-8 | CAS number: 4345-03-3
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:
- guideline study
- Remarks:
- non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- [(2R)-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] acetate
- Cas Number:
- 7695-91-2
- Molecular formula:
- C31H52O3
- IUPAC Name:
- [(2R)-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-yl] acetate
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Vitamin E acetate
- Lot/batch No.: batch no. 7459
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Savo Med. Versuchstierzuchten GmbH, Kisslegg (Germany)
- Age at study initiation: no data
- Weight at study initiation: 2.47 kg (male) 2.25 kg (male) and 2.40 kg (female
- Housing: individually in cages without bedding
- Diet: Kliba 341, ca. 130 g/day
- Water: tap water, ca. 250 ml/day
- Acclimation period: at least 8 days before the beginning of the study, same housing conditions as during the study
The rabbits were identified by ear tattoo.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 (6.00-18.00 h/18.00-6.00 h)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- The fur of each rabbit was clipped at least 15 hours prior to the start of the study.
TEST SITE
- Area of exposure: upper third of the back or flanks
- % coverage: no data
- Type of wrap if used: Test patches (size: 2.5 cm x 2.5 cm) were secured in position with a porous dressing (4 layers of absorbent gauze and porous bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Draize scores: 30-60 minutes after removal of the test patches and at 24, 48, and 72 hours after beginning of application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test substance was not irritating. Mean score was 0.0 for both erythema and edema.
Very slight (grade 1) erythema was observed in 3/3 rabbits at the 4-hour reading. The skin of all animals was normal at the 24-hour reading and later.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not a skin irritant, mean score was 0.0 for both erythema and edema.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404 study. The undiluted test substance was applied to the skin of three Vienna White rabbits for 4 hours. Under the study conditions, the test substance was not a skin irritant, mean score was 0.0 for both erythema and edema (BASF, 1989).
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