Registration Dossier
Registration Dossier
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EC number: 812-925-4 | CAS number: 1639345-42-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 10 - June 25, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-[fluoro(dimethyl)silyl]butanenitrile
- EC Number:
- 812-925-4
- Cas Number:
- 1639345-42-8
- Molecular formula:
- C6H12FNSi
- IUPAC Name:
- 4-[fluoro(dimethyl)silyl]butanenitrile
- 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
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Housing: ABS - plastic rabbit or Noryl rabbit cages, floor 4200 cm²
- Diet: ad libitum, Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Water: ad libitum, tap water
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Due to the persistent lesions 72 hours after the patch removal, the observation period was extended
in order to evaluate the reversibility or irreversibility of the lesions. Therefore, animal no. 1 was
observed for 10 days, animal no. 2 was observed for 9 days and animal no. 3 was observed for
4 days. - Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 d
- Irritant / corrosive response data:
- The test item showed slightly irritant (erythema up to grade 2, oedema up to grade 2), but no corrosive effects on the intact skin of three male rabbits (strain NZW) after a contact time of 4 hours. All signs of irritation were completely reversible within up to 10 days after patch removal.
- Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- The test item showed slightly irritant (erythema up to grade 2, oedema up to grade 2), but no corrosive effects on the intact skin of three male rabbits (strain NZW) after a contact time of 4 hours. All signs of irritation were completely reversible within up to 10 days after patch removal.
- Executive summary:
In this irritation study the test item was applied to one site of the closely clipped backs of three male rabbits (strain NZW) at a dose of 0.5 mL per application site. The untreated other side served as control.
The application site was covered with a semi-occlusive bandage for a 4-hour contact time.
Neither mortalities nor significant clinical signs of toxicity were observed.
Under the conditions of the present study, the test item showed irritant but no corrosive effects which were fully reversible within up to 10 days.
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