Registration Dossier
Registration Dossier
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EC number: 216-088-0 | CAS number: 1493-27-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Draize test (exposure of 24 hours), sufficiently detailed, no GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure of 24 hours instead of 4 hours
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-fluoro-2-nitrobenzene
- EC Number:
- 216-088-0
- EC Name:
- 1-fluoro-2-nitrobenzene
- Cas Number:
- 1493-27-2
- Molecular formula:
- C6H4FNO2
- IUPAC Name:
- 1-fluoro-2-nitrobenzene
- Test material form:
- other: liquid
- Details on test material:
- no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2 cm²
- Type of wrap if used: no data
SCORING SYSTEM:
Erythema
No erythema .........................................................................................................................0
slight erythema (barely perceptible...................................................................................1
Well-defined erythema ........................................................................................................2
Moderate to severe erythema.............................................................................................3
Severe erythema (beet redness) to slight eschar formation (injuries in depth).........4
Edema
No edema..................................................................................................................................0
Very Slight edem(barely perscepible)...................................................................................1
Slight edema (edges of area well defined by definite raising)...........................................2
Moderate edema (raised approximately 1 mm)...................................................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure).......4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: no score at 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no score at 48 hours
- Irritant / corrosive response data:
- For more details see table in field " Any other information on results incl. tables".
- Other effects:
- none
Any other information on results incl. tables
Table: skin irritation score
| Individual score (6 rabbits) | Intact skin | Abraded skin | ||
| 24 h | 72 h | 24 h | 72 h | |
| Erythema | 0/0/0/1/0/0 | 0/0/0/0/0/0 | 0/0/0/1/0/0 | 0/0/0/0/0/0 |
| Edema | 0/0/0/0/0/0 | 0/0/0/0/0/0 | 0/0/0/1/0/0 | 0/0/0/0/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this test, the substance is not irritating to skin.
- Executive summary:
In this acute dermal irritation/corrosion test, 0.5 ml of the undiluted substance has been applied in a single dose to the intact or abraded skin of six rabbits during 24 hours. No irritant effect has been observed. Based on the result of this test, the substance is not classified according to CLP.
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