Registration Dossier
Registration Dossier
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EC number: 429-460-4 | CAS number: 7078-98-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-02-25 - 1998-04-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 404) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted on 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-460-4
- EC Name:
- -
- Cas Number:
- 7078-98-0
- Molecular formula:
- C21 H26 O
- IUPAC Name:
- 2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, U.S.A. (on 2/10 and 2/17/98)
- Age at study initiation: born the weeks of 11/30 through 12/14/97
- Weight at study initiation: 2.2 – 2.5 kg (males/females)
- Housing: 1 rabbit/cage in suspended wire cages
- Diet: Fresh Purina Rabbit Chow, provided daily
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: temperature controlled
- Humidity: Not indicated
- Photoperiod: 12 hours dark / 12 hours light
- Other: Room was kept clean and vermin free
IN-LIFE DATES: From: 1998-03-03 To: 1998-03-06
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g/rabbit, placed under a patch moistened with 1 mL of 0.9 % (w/v) sodium chloride solution - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after patch removal (assessment of skin reactions at 0.5 - 1, 24, 48 and 72 hour(s) after patch removal)
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- 24 hours before treatment, the dorsal area of the trunk of each animal was clipped free of hair
- Area of exposure: approximately 10 x 10 cm
- Type of wrap: Moistened surgical gauze patch (2.5 x 2.5 cm) with the test item - applied to the intact skin of the clipped area – was gentle pressed and secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water to remove residual test item
- Time after start of exposure: 4 hours after the application of the test item
SCORING SYSTEM: numerical Draize technique
OBSERVATIONS
- Dermal irritation: 0.5- 1 hour post patch removal and again at 24, 48 and 72 hours post patch removal
- The general health of the animals was monitored at each observation time
- Body weights were recorded pretest
- Necropsy: no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.11
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.11
- Max. score:
- 4
- Irritant / corrosive response data:
- IRRITATION:
Erythema and edema, absent at 30 to 60 minutes after patch removal, were absent to very slight at 24 and 48 hours and cleared by 72 hours. - Other effects:
- The dose sites were stained yellow until to the end of the observation period.
Any other information on results incl. tables
SYSTEMIC OBSERVATIONS
- There were no abnormal systemic signs noted during the observation period.
- Body weight changes were normal.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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