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Registration Dossier
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EC number: 248-227-6 | CAS number: 27107-89-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1st September 1992 - 11th September 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted on less pure form of the substance, namely a mixture of MOTE and DOTE with the ratio of MOTE:DOTE being 70:30.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
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:
- Octyltin tris(2-EHMA) [CAS No. 27107-89-7]:Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1] (70:30% mixture); colorless liquid.
- IUPAC Name:
- Octyltin tris(2-EHMA) [CAS No. 27107-89-7]:Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1] (70:30% mixture); colorless liquid.
- Details on test material:
- Octyltin tris(2-EHMA) [CAS No. 27107-89-7]:Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1] (70:30% mixture); colorless liquid.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: NDA
- Weight at study initiation: 2350 - 2670 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1st September 1992 To: 11th September 1992
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control patch on left side of the animal.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): N/A
VEHICLE
- N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days.
Skin observations recorded at 1, 24, 48 and 72 hours according to the OECD scoring system. - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 12 - 16 cm²
- % coverage: NDA
- Type of wrap if used: gauze patch covered with aluminium foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed
- Time after start of exposure: N/A
SCORING SYSTEM: OECD 404 scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Because reactions were observed within 7 days after removing the bandages, the observation period was extended to 10 days to determine the reversibility of the skin reactions. Scaling was observed in all animals on day 7.
The skin reactions observed were reversible until the end of the observation period on day 10. - Other effects:
- None
Any other information on results incl. tables
Table 1. Individual skin reaction scores.
| Erythema | Edema | |||||
| Animal number | 738/F CF/TF | 856/F CF/TF | 720/F CT/TF | 738/F CF/TF | 856/F CF/TF | 720/F CT/TF |
| After 1 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/2 |
| After 24 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
| After 48 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
| After 72 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
| Mean 24-72 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
| After 7 days | 0/1s | 0/1s | 0/1s | 0/0 | 0/0 | 0/0 |
| After 10 days | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 |
CF: Control flank
TF: Test flank
s: Scaling
Table 2. Individual bodyweights.
| Animal number | 738/F | 856/F | 720/F |
| At start of test | 2350 | 2670 | 2560 |
| After 3 days | 2360 | 2780 | 2500 |
| After 7 days | 2470 | 2900 | 2700 |
| After 10 days (end) | 2580 | 2990 | 2750 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed TK 10315/S induced erythema and oedema reactions when applied to the clipped albino rabbit skin.
The reactions were reversible by the reading 10 days after application. - Executive summary:
TK 10315/S (Mono-n-octyl-tin-tris-(2-ethylhexylmercaptoacetate)) was applied to the skin female New Zealand White rabbits via an occlusive patch. The test was conducted according to OECD 404 and performed to GLP. The patch was applied for 4 hours and the rabbits were then observed for 10 days.
Under the experimental conditions employed TK 10315/S induced erythema and edema reactions when applied to the clipped albino rabbit skin.
The reactions were reversible by the reading 10 days after application.
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