Registration Dossier
Registration Dossier
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EC number: 911-467-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Jun 2018 to 10 Sep 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP Guideline study
- Justification for type of information:
- The in vivo data have been generated as part of a new substance notification in China for which this test is a standard requirement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2017
- Deviations:
- yes
- Remarks:
- See below
- Principles of method if other than guideline:
- Deviations:
- Six times points of humidity deviated with the highest value measured being 73%. Deviations were very short time periods. This does not affect the quality and integrity of the study.
- At 24 and 48h, the observation of one of the animals deviated by about 4h. Because no dermal irritant symptoms were seen, this deviation was considered not to affect the quality and integrity of the study. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2016-05-30
Test material
- Reference substance name:
- Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate
- EC Number:
- 911-467-3
- Molecular formula:
- C2O2F3K and CO2F3KS
- IUPAC Name:
- Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
- Remarks:
- Aqueous solution
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Qinqdao Kangda Biological Technology Limited Company
- Age at study initiation: 92-95 days
- Weight at study initiation: 2018-2293 g
- Housing: Individually in stainless wire cages
- Diet (e.g. ad libitum): rabbit maintenance feed, ad libitum
- Water (e.g. ad libitum): purified drinking water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9
- Humidity (%): 47-73
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 Jun 2018 To: 28 Jun 2018
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4h
- Observation period:
- 72h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5cm
- Type of wrap if used: elastic bandage and medical paper tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substances wiped off with cotton moisted with tepid water
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
Immediately, 1, 24, 48 and 72h after patch removal
SCORING SYSTEM:
- Method of calculation: according to the guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no observable abnormalities for the three control sites and for the three test sites.
- Other effects:
- No abnormal signs or symptoms were observed.
All animals showed expected gains in body weights.
Any other information on results incl. tables
| Individual scores - Observation time (hour) | Mean scores 24-48-72h | |||||
| 1 | 24 | 48 | 72 | |||
| Animal 1 | Edema | 0 | 0 | 0 | 0 | 0 |
| Erythema | 0 | 0 | 0 | 0 | 0 | |
| Animal 2 | Edema | 0 | 0 | 0 | 0 | 0 |
| Erythema | 0 | 0 | 0 | 0 | 0 | |
| Animal 3 | Edema | 0 | 0 | 0 | 0 | 0 |
| Erythema | 0 | 0 | 0 | 0 | 0 | |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Reaction mass of TFSK/TFAK is not iritating to the skin.
- Executive summary:
In an in vivo skin irritancy study following OECD TG 404 and under GLP conditions, three rabbits were dosed with 0.5 mL of the test substance. No mortality or systemic toxicity was observed. All erythema and edema scores were equal to 0. Based on the outcome of this study, it can be concluded that the test substance is not classified as corrosive or irritant to the skin.
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