Registration Dossier
Registration Dossier
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EC number: 940-594-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 2-(1,1-dimethylethyl)-4-{[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio}-5-methylphenyl 3-(dodecylthio)propionate and thiobis[2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene] bis[3-(dodecylthio)propionate]
- EC Number:
- 940-594-7
- Molecular formula:
- C52H86O4S3 , C37H58O3S2
- IUPAC Name:
- Reaction mass of 2-(1,1-dimethylethyl)-4-{[5-(1,1-dimethylethyl)-4-hydroxy-2-methylphenyl]thio}-5-methylphenyl 3-(dodecylthio)propionate and thiobis[2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene] bis[3-(dodecylthio)propionate]
- Test material form:
- liquid
- Details on test material:
- Intended use: Antioxidant for plastics
Appearance: Brown liquid
Storage conditions: Room temperature protected from light
Supplier: Sponsor
Lot number: 102Y1
Expiry date: 30 April 2014
Purity 98.8%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animals for this study were selected from a stock supply of healthy adult rabbits of the New Zealand White strain.
- Age at study initiation: 38 weeks
- Weight at study initiation: 3.91 to 4.43 kg
- Housing: The rabbits were housed individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): 125 g of a standard laboratory rabbit diet per day
- Water (e.g. ad libitum):Drinking water was provided ad libitum.
- Acclimation period:All rabbits were acclimatised to the experimental environment for a period of 21 weeks prior to the start of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light):Lighting was controlled by means of a time switch to give 12 hours of artificial light (06:00 to 18:00 GMT) in each 24 hour period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Approximately 0.5 mL of the test substance was applied under a 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape to intact skin sites on three animals.
- Duration of treatment / exposure:
- Three minutes, one and four hours
- Observation period:
- 1, 24, 48 and 72 hours later.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorso-lumbar region of each rabbit
- % coverage: 25 mm x 25 mm
- Type of wrap if used: porous gauze pad secured with ‘blenderm’ surgical tape to intact skin sites on three animals.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: 72 hours
OBSERVATION TIME POINTS (hours): 1, 24, 48 and 72
SCORING SYSTEM:
- Method of calculation: A primary irritation index (PII) was calculated from the erythema and oedema scores.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no sign of toxicity or ill health in any rabbit during the observation period. No dermal reaction was observed in any animal throughout the duration of the study.
- Executive summary:
The Primary Irritation Index was calculated to be 0.0; AO-26 was classified as ‘non-irritant’ according to the criteria of the ECETOC and did not require labelling in accordance with Commission Regulation 1272/2008.
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