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EC number: 943-535-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
- Vapour pressure
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-07-15 to 2014-08-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 1 hour observation performed ca. 2.5 hours after patch removal.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 1 hour observation performed ca. 2.5 hours after patch removal.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Succinic anhydride, alkylation products with C12-rich branched olefins from propene oligomerisation, hydrolyzed, esterification products with propylene oxide
- EC Number:
- 943-535-3
- Molecular formula:
- C19H34O5
- IUPAC Name:
- Succinic anhydride, alkylation products with C12-rich branched olefins from propene oligomerisation, hydrolyzed, esterification products with propylene oxide
- Details on test material:
- - Physical state:amber coloured viscous liquid
- Analytical purity: 100%
- Expiration date of the lot/batch: 17 March 2016
- Storage condition of test material: room temperature on the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlon Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.46 kg and 2.66 kg
- Housing: individual suspended cages
- Diet (e.g. ad libitum): 2930C Teklad Global Rabbit Diet ad libitum
- Water (e.g. ad libitum): mains drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark
IN-LIFE DATES: From: 2014-07-15 To: 2014-08-19
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- Area of exposure: 1st rabbit: 3 sites on back or rabbit, 2nd rabbit: 1 site
- Type of wrap if used: Cotton gauze patch secured with surgical adhesive tape. Trunk of rabbit wrapped in elasticated corset.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 1st rabbit: 3 mins, 1 hour (2.5 hour as per deviation) and 4 hours. 2nd rabbit: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 14 days
- Remarks on result:
- other: glossy skin noted at both sites but erythema fully reversed.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- See attached document for table of scores and observations.
No corrosive effects were noted
3 minutes
No evidence of skin irritation was noted during the study.
1 hour exposure
Very slight erythema was noted at the treated skin site at the treated skin site at the 24-hour observation with well-defined erythema and very slight oedema noted at the 48-hour observation and very slight erythema and very slight oedema at the 72-hour observation.
The treated skin appeared normal atthe 7-day observation.
4-hour exposure
Very slight erythema and very slight oedema were noted at one treated site 1 hours after patch removal. Well-defined erythema and very slight oedema were noted at both treated skin sites at the 24-hour observation with well-defined erythema and slight oedema noted at the 8 and 72-hour observations. Well-defined erythema and very slight oedema were noted at one treated skin site at the 7-day observation. - Other effects:
- 4 hour exposure
Loss of skin elasticity and flexibility were noted at both treated skin sites at the 48 and 72-hour observations and at one treated skin site at the 7-day observation. Light brown discolouration of the epidermis was also noted at both treated skin sites at the 72-hour observation. Superficial cracking of the epidermis was also noted at one treated skin site at the 7-day observation. Crust formation was noted at one treated skin site at the 7 and 14-day observations and preventedaccurate evaluation of erythema and oedema at teh 7-day observation. Glossy skin was noted at the other treated skin site at the 14-day observation.
Body weight
Both animals showed expecetd gain in body weigt during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the primary effects, erythema and edema, were reversed by the end of the observation period and the scores for erythema did not fall within the range requiring classification..
- Executive summary:
Test Guidance
OECD Guideline No. 404 and EU Method B4
Method and materials
An acute dermal irritation study was conducted using undiluted test substance on New Zealand white rabbits. Initially, one rabbit was used and three patches of 0.5 mL test substance/site was applied on to clipped unabraded skin under a 2.5 cm x 2.5 cm cotton guaze patch. One patch was removed following 3 minutes, 1 hour and 4 hours after application. After consideration of the skin reactions observed in animal 1, one further animal was treated. The test substance was administered once and the patch remained in contact with the skin for 4 hours and then followed by removal of the patch containing the test article. Following the exposure periods, the bandages were removed and the application sites were evaluated in accordance with the method of Draize at approximately 24, 48, and 72 hours after patch removal and daily through Day 14.
Results
The mean total scores for erythema and oedema were 2 and 1.67 respectively. All erythema and oedema was reversible by the 14 day observation period.
A single 4 -hour, semi-occluded application of the test item to intact skin of two rabbits produced well-defined erythema and slight oedema. Other dermal reactions noted were loss of skin elasticity and flexibility, light brown disolouration of the epidermis, superficial cracking of the epidermis, crust formation and glossy skin. On one occasion the reactions noted prevented the accurate evaluation of erythema and oedema. No corrosive effects were noted.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for dermal irritation as the primary effects, erythema and edema, were reversed by the end of the observation period and the scores for erythema did not fall within the range requiring classification.
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