Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2013-01-28 to 2013-02-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: According to ECHA Practical Guide 6 the maximum score for read across is rel. 2
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: LPT, Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: female
- Age: approx .6.5 - 10.5 months
- Weight at study initiation: 2.7 kg to 3.2 kg
- Housing: single
- Diet: ad libitum, ssniff K-H (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: untreated skin surrounding the application area
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml test item/patch and animal
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: unchanged
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance, approx. 6 cm2
- Concentration: 0.5 mL of the test item was applied to the test site (area: approx. 6 cm2).
- Occlusion: gauze patch held in place by semi-occlusive non-irritating tape dressing
- Washing: at the end of the exposure time no residual test item had to be removed.
- Inital test: As there was no evidence of the test item producing severe irritancy or corrosion by the test item, a single patch was applied to one
animal for 4 hours.
- Confirmatory test: As no corrosive or severe irritant effects were observed in the initial test, 2 further animals were employed 24 hours after start
of the initial test.
EXAMINATIONS
- Examination time points: 60 minutes, 24, 48, 72 hours,
- Scoring system: Draize (0-4 possible scores each for erythema/eschar and for edema)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0
- Edema: 0 - Other effects:
- no other effects
Any other information on results incl. tables
Findings Examination Skin irritation scores
of the skin schedule
animal no.
1 2 3
E/Oe E/Oe E/Oe
500 ml substance/patch/animal
erythema and
eschar formations/ before dosing 0/0 0/0 0/0
oedema formation
time after removal
of the patch
(4-hour exposure)
60 min 0/0 0/0 0/0
24 hours 0/0 0/0 0/0
48 hours 0/0 0/0 0/0
72 hours 0/0 0/0 0/0
0 no pathological findings
E erythema and eschar formations
Oe oedema
Applicant's summary and conclusion
- Conclusions:
- Under the present test conditions, none of the three male rabbits exposed for 4 hours to 500 ml test item/patch (semi-occlusive conditions) showed any skin reaction. There were no systemic intolerance reactions. Therefore, the test item was non-irritating to skin, hence no labelling is required.
- Executive summary:
The purpose of this study was to examine the test substance for acute dermal irritation/corrosion properties in rabbits (patch test), according to OECD guideline 404, EC method B.4.and OCSPP guideline 870.2500.
Under the present test conditions, none of the three male rabbits exposed for 4 hours to 500 ml test item/patch (semi-occlusive conditions) showed any skin reaction. There were no systemic intolerance reactions. Therefore, the test substance was non-irritating to skin, hence no labelling is required.
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