Registration Dossier
Registration Dossier
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EC number: 426-650-9 | CAS number: 191743-75-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998-02-05 - 1998-04-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 426-650-9
- EC Name:
- -
- Cas Number:
- 191743-75-6
- Molecular formula:
- Unspecified
- IUPAC Name:
- 2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products
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 (on 01/20/98)
- Age at study initiation: Animals were born the weeks 11/09 through 11/23/97, Experimental Start Date: 02/10/98
- Weight at study initiation: 2.0 – 2.5 kg (1 male/ 5 females)
- Housing: 1 animal/sex/cage in suspended wire cage, bedding was changed three times/week
- Diet: Fresh Purina Rabbit Chow, provided daily
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hours dark / 12 hours light
- Animal room was temperature controlled, kept clean and vermin free
IN-LIFE DATES: From: 1998-02-10 To: 1993-02-13
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g, based on the dry weight - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after patch removal
- Number of animals:
- 6 rabbits (1 male, 5 females)
- Details on study design:
- TEST SITE
- 24 h before: Dorsal area of the trunk of each animal was clipped free of hair
- Area of exposure: approximately 10 x 15 cm
- Test item was placed under a 2.5 x 2.5 cm surgical gauze patch moistened with distilled water
- Gentle pressure was applied to the gauze to aid in the distribution of the test item
- Patch was secured with non-irritating tape
- Type of wrap: 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: Residual test item was gently washed with distilled water from the dose site prior to dermal observations.
OBSERVATIONS
- Duration of observation period following administration: 72 hours
- Test sites were scored for dermal irritation at 30 to 60 minutes post patch removal and again at 24, 48 and 72 hours post patch removal using the numerical Draize scoring code. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Additional signs were described.
- The general health status of the animals was monitored at each observation time.
- Frequency of weighing: recorded pretest
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Erythema and edema were absent at all observation intervals. The modified Primary Initation Index was 0.
- Other effects:
- There were no abnormal systemic signs noted during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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