Registration Dossier
Registration Dossier
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EC number: 441-000-4 | CAS number: 121219-07-6 1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-01-26 to 2000-02-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 29 Decembre 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-ethoxy-2,3-difluorobenzene
- EC Number:
- 441-000-4
- EC Name:
- 1-ethoxy-2,3-difluorobenzene
- Cas Number:
- 121219-07-6
- Molecular formula:
- Hill formula: C8H8F2O
- IUPAC Name:
- 1-ethoxy-2,3-difluorobenzene
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 Wiga GmbH, Kißlegg, Germany
- Age at study initiation: about 16 weeks
- Weight at study initiation: 3.27 kg (range from 3.20 to 3.36)
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm;)
- Diet: ad libitum, pellets (Altromin Standard Diet TPF(R) 2113)
- Water: ad libitum, tap water
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 37 - 64
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 8 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: left side of the animals backs (3 patches of about 6 cm²
- Type of wrap: self-adhesive fabric (Fixomull® stretch, Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
1, 24, 48, 72 hours and then daily upt o study day 8
SCORING SYSTEM:
- Method of calculation: according to the DRAIZE-, OECD- and EEC recommendations
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation were observed in any of the 3 animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the conducted study, the test substance is not regarded as irritant to the skin.
- Executive summary:
The test on skin irritation was performed in accordance with OECD TG 404. The test substance (0.5 mL) was spread onto 6 cm² patches (3) and applied to the intact skin of 3 previously shaven New Zealand White rabbits (females) for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 8 days.
Under the conditions of the present study, no signs of toxicity were seen.
Evaluation of each animal:
Mean score (24h, 48h, 72h)
Maximum value (24h, 48h, or, 72h)
Animal No.
1
2
3
1
2
3
Erythema
0
0
0
0
0
0
Edema
0
0
0
0
0
0
No signs of irritation were observed in any of the 3 animals. Thus, the test material was not considered as a irritant to the skin.
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