Registration Dossier
Registration Dossier
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EC number: 700-699-9 | CAS number: 877397-65-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 Aug to 02 Sep 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- (1S)-1-(2,6-dichloro-3-fluorophenyl)ethan-1-ol
- EC Number:
- 700-699-9
- Cas Number:
- 877397-65-4
- Molecular formula:
- C8H7Cl2FO
- IUPAC Name:
- (1S)-1-(2,6-dichloro-3-fluorophenyl)ethan-1-ol
Constituent 1
- Specific details on test material used for the study:
- - Purity: 100.0 % area (HPLC)
- Batch No.: E010010678 (PFI-09-01-097)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: between 10-20 weeks old
- Weight at study initiation: 2-4 kg
- Housing: housed in labeled cages with perforated floors and shelters
- Diet (e.g. ad libitum): Pelleted diet approximately 100 grams per day, Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: At least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC (actual range: 19.0-19.9ºC)
- Humidity (%): 40-70% (actual range: 49 - 87%)
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day
IN-LIFE DATES: From: 2010-08-24 To: 2010-09-02
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 150 square centimeters (10x15 cm)
- % coverage:
- Type of wrap if used: Micropore tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: numerical scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 475
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal: 486
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- erythema score
- Basis:
- animal: 489
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- edema score
- Basis:
- animal: 475
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- edema score
- Basis:
- animal: 489
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritation parameter:
- edema score
- Basis:
- animal: 486
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: The exposure period is 4 hours.
- Irritant / corrosive response data:
- Four hours exposure to 0.5 g of test substance resulted in very slight erythema in the treated skin areas of the three rabbits. The skin irritation resolved within 24 hours after exposure in all animals.
There was no evidence of a corrosive effect on the skin. - Other effects:
- No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Individual skin irritation scores
Animal |
475 |
489 |
486 |
|||
Time after exposure |
Erythema (0-4) |
Oedema (0-4) |
Erythema (0-4) |
Oedema (0-4) |
Erythema (0-4) |
Oedema (0-4) |
1 hour |
1 |
0 |
1 |
0 |
1 |
0 |
24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- No skin irritation was caused by 4 hours exposure to the test substance.
- Executive summary:
Primary skin irritation/corrosion study with PF-00968603 in the rabbit (4-hour semi-occlusive application).
The study was carried out based on the guidelines described in: OECD No.404, "Acute Dermal Irritation/Corrosion" (2002) EC, No 440/2008; B4: "Acute Toxicity: Dermal Irritation/Corrosion" US EPA, OPPTS 870.2500 (1998), Acute Dermal Irritation JMAFF Guidelines (2000) including the most recent partial revisions.
Three rabbits were exposed to 0.5 grams of PF-00968603, moistened with water, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
Exposure to PF-00968603 resulted in very slight erythema in the treated skin areas of the three rabbits. The skin irritation resolved within 24 hours after exposure in all animals.
No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
Based on these results PF-00968603 does not have to be classified and has no obligatory labelling requirement for skin irritation according to the: - Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007), - Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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