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Registration Dossier
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EC number: 807-619-2 | CAS number: 65535-29-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June to July 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 67/548/EEC in the version of Directive 93/21/EEC
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 17 July 1992
- Deviations:
- yes
- Remarks:
- exposure time 24 hrs instead of 4 hrs, 6 animals instead of 3, few details in test description and reporting
- Principles of method if other than guideline:
- A combined study on acute dermal toxicity and on local tolerance was used to assess skin irritation/corrosion (comparable to OECD TG 402 and 404). The study design and reporting deviates from the current OECD TG 404, however, the study is considered sufficient for assessment of this endpoint. As described in ATP 96/54/EC ANNEX IV A, PART B: METHODS FOR THE DETERMINATION OF TOXICITY AND OTHER HEALTH EFFECTS, a strategy of testing for irritancy allows the non-performance of a test if an acute toxicity study by the dermal route has been conducted at the limit test dose with the substance (method B.3), and no skin irritation was observed, further testing for skin irritation (method B.4) may be unnecessary.
- GLP compliance:
- yes
- Remarks:
- - but a QA check was not performed
Test material
- Reference substance name:
- 9beta, 11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
- Cas Number:
- 65535-29-7
- Molecular formula:
- C27 H35 F O5
- IUPAC Name:
- 9beta, 11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: males: 105-111 g; females: 93-107 g
- Fasting period before study: ca. 19 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): pell. Altromin® R ad libitum
- Water (e.g. ad libitum): demineralized acidified water, pH 2-3 ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 54-64
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: 900 mg NaCl ad 100 ml bidest water
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 210-222 mg/male animal or 186-214 mg/female animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight on day 1, 7, and 14.
- Necropsy of survivors performed: yes
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The test was conducted according to Directive 67/548/EEC which requires the 24, 48 and 72h measurement timepoints. However, the exact timepoints were not reported.
- Other effects:
- none
Applicant's summary and conclusion
- Conclusions:
- A single dermal administration of the test substance for 24 hours to male and female rats at a dose of 2000 mg/kg bw (210-222 mg/male and 186-214 mg/female applied as a paste) was tolerated without any local irritations. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) during the observation period of 14 days were 0. Therefore, local application of the test item was tolerated without irritation of the skin.
- Executive summary:
In a primary dermal irritation study similar to OECD TG 404 (adopted 17 July 1992), (3/sex) female and male Wistar rats were dermally exposed to 186-214 mg females and 210-222 mg males of Epoxide-Valerate (100% a.i). in physiological saline. Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 14 days. Evaluation of skin reactions (reddening, scab formation and swelling of the skin) was done according to the system recommended in Directive 67/548/EEC.
A single dermal administration of the test item for 24 h was tolerated without any local irritations. In this study, the test item is not a dermal irritant.
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