Registration Dossier
Registration Dossier
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EC number: 903-945-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- from 03 jan 1990 to 19 sept 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, OECD 404 compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Chlorodifluoroacetic acid
- EC Number:
- 200-928-8
- EC Name:
- Chlorodifluoroacetic acid
- Cas Number:
- 76-04-0
- Molecular formula:
- C2HClF2O2
- IUPAC Name:
- chloro(difluoro)acetic acid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bancel (Albon - 26140 Saint Rambert d'Albon - France)
- Age at study initiation: adult, 3 males
- Weight at study initiation: 2.4 and 2.5 kg
- Housing: Individually in polystyrene cages (560 x 355 x 315 mm)
- Diet (e.g. ad libitum): 150 g pe animal and per day of rabbits food pellets (U.A.R, formula 112 - U.A.R, Villemoison - 91360 Epinay/Orge - France)
- Water (e.g. ad libitum): softened and filtered water (15 µm), ad libitum
- Acclimation period: 13 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h, lighting: 7h30 - 19h30
IN-LIFE DATES: From 03 jan 1990 To 05 jan 1990
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:
- 4 hours
- Observation period:
- 14 days maximum
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: 6 cm²
- Type of wrap if used: perforated adhesive tape 10 cm width.
SCORING SYSTEM: EU
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Animals were killed at 48 hours for human reason
- Remarks on result:
- other: Necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- > 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- Animals were killed at 48 hours for human reason
- Remarks on result:
- other: reaction bigger than application area
- Other effects:
- Total necrosis of the skin. That's why all animals were killed at 48 hours.
Any other information on results incl. tables
Results:
Observation time |
Erythema |
Edema |
1 hour |
4a/4a/4a |
4/4/3> |
24 hours |
4a/4a/4a |
3>/4/4 |
48 hours |
4n>/4n>/4n> |
n/n/n |
72 hours |
-/-/- |
-/-/- |
Mean (24, 48 and 72 h) |
4/4/4 |
-/-/- |
a : eschar on application area
> : Reaction bigger than application area
n: total necrosis of the skin
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive)
- Conclusions:
- Chlorodifluoroacetic acid is corrosive category 1 according to CLP 1272/2008/EC. However, the exposition time of 4 hours does not allow to differentiate between A, B or C categories.
- Executive summary:
In a GLP study, 0.5 ml of Chlorodifluoroacetic acid was applied on the back or flanks, of 3 New Zealand White rabbits (males), under semiocclusive conditions during 4 hours.
The highest score (4) was observed only after 1 hour of observation.
Regarding the total necrosis observed in all animals, bigger than the application area, animals were killed for human reason after 48 hours.
Based on these observation, Chlorodifluoroacetic acid can be classified as corrosive for the Skin, Category 1 according to CLP 1272/2008/EC. In absence of shorter exposition time it is not possible to apply a stronger classification based on this study alone.
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