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Registration Dossier
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EC number: 608-605-7 | CAS number: 313482-99-4
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-12-17 to 2002-12-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester
- EC Number:
- 608-605-7
- Cas Number:
- 313482-99-4
- Molecular formula:
- C22H26O5Si
- IUPAC Name:
- 9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester
- Test material form:
- solid
- Details on test material:
- - State of aggregation: yellow mass (frozen melt)
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the freezer protected from light, under nitrogen
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 8 - 10 weeks old
- Weight at study initiation: 1823 - 1904 g
- Housing: individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56 x 44 x 37.5 cm)
- Diet: standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany) approx. 100 g/day; pressed hay (BMI, Helmond, the Netherlands) twice a week
- Water (ad libitum): tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative Humidity: 30 - 70 %
- Air changes: approx. 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: corn oil
- Controls:
- no
- Amount / concentration applied:
- NOTE: since the test substance did not mix with water, the powdery test substance was moistened with corn oil, heated up to approximately 40 °C, immediately before application, to ensure close contact with the animal's skin.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams of the lest substance moistened with corn oil - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- NOTE: all available data relevant to the potential dermal irritation/corrosivity of the substance indicated that no significant irritation was to be expected. Therefore, this in-vive skin irritation study was started with three animals.
TEST SITE
- Area of exposure, % coverage and type of wrap: approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10 x 15 cm²). Whenever considered necessary the treated skin areas were re-clipped at least 3 hours before the observations, to facilitate scoring.
The test substance was moistened with the vehicle and applied to the skin of one flank, using a metalline patch' of 2 x 3 cm. The patch was mounted on Micropore tape', which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin cleaned of residual test substance using water.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
Approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance
SCORING SYSTEM: Draize scale
OBSERVATIONS:
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- Body Weight: day of treatment (prior to application) and at termination
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see "Remarks"
- Remarks:
- dry remnants of the test substance present 1 hour after application
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: see "Remarks"
- Remarks:
- dry remnants of the test substance present 1, 24 and 48 hours after application
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- other: see "Remarks"
- Remarks:
- dry remnants of the test substance present 1 hour and 24 hours after application
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Four hours exposure to 0.5 g of TESAC resulted in well-defined erytherna and slight oederna in lhe treated skin-areas of two rabbits and well-defined erythema and very slight oedema in the other animal. The skin irritalion had resolved within 48 hours.
There was no evidence of a corrosive effect on the skin.
No staining of the treated skin by the test substance was observed. Sticky remnants of the test substance were observed in all animals immediately after removal of the bandage. Dry remnants of the test substance were present on the skin 1 hour after treatment in one animal, 24 hours after treatment in the second animal and 48 hours after treatment in the last animal. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
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