Registration Dossier
Registration Dossier
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EC number: 247-744-4 | CAS number: 26495-91-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb 12 - March 18, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24th April, 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 454-780-6
- EC Name:
- -
- Cas Number:
- 27445-54-1
- Molecular formula:
- Hill formula: C12H27NO2Si CAS formula: C12H27NO2Si
- IUPAC Name:
- Cyclohexyl-((diethoxy-methyl-silanyl)-methyl)-amine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test Animals
New Zealand White Rabbits HsdIf:NZW.
Three female animals were used.
A single animal initial test was employed first.
The animals were derived from a controlled full barrier maintained breeding system (SPF).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Animal Husbandry
Semi-barrier in an air conditioned room
Temperature: 18 ± 3°C
ReI. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to Altromin 2123 maintenance diet for rabbits, rich in crude
fibre, totally pathogene free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period
Preparation ofthe Animals
Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0,5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- Application:
The test item was applied in a single dose to a small area (approx. 6 cm2) of skin on one side of the dorsal area with a gauze patch, which was held in place with non-irritating tape. The untreated other side served as control. The test item was applied to the patch first, and then applied to the skin. The patch was fixed with a semi-occlusive dressing.
Exposure Period:
Test item was held in contact with the skin throughout a 4-hour period. At the end ofthe exposure, residual test item was removed by using tap water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effect observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 h
- Irritant / corrosive response data:
- The test item Geniosil® XL 924 showed slight irritant, but no corrosive effects on the intact skin after a contact time of 4 hours.
- Other effects:
- No clinical signs oftoxicity were found.
There were no significant body weight changes during the contact and observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the test item showed slight irritant effects below the criteria for classification and labelling.
- Executive summary:
The test for acute dermal irritation/corrosion according to OECD Guideline No. 404 was performed with the test item.
Considering the reported data of this irritation study it can be stated that the test item showed slight irritant, but no corrosive effects.
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