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EC number: 247-279-7 | CAS number: 25811-35-2
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 02 Feb - 05 Feb 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (no analytical purity reported)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- Deviations:
- yes
- Remarks:
- no analytical purity reported
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- EC Number:
- 267-022-2
- EC Name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- Cas Number:
- 67762-53-2
- IUPAC Name:
- 67762-53-2
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow liquid
- Analytical purity: not reported
- Lot/batch No.: CRU 98433
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino Rabbits; New Zealand White, HM: (NZW)fBR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Inc., Hewitt, NJ, USA
- Age at study initiation: at least 8 weeks old
- Weight at study initiation: 2.5 – 2.8 kg
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: certified Lab Rabbit Diet, HF, No. 5325; PMI Feeds, Inc. St. Louis, MO (approx 125 g/day while on test)
- Water: automatic watering system, municipal water supply, ad libitum
- Acclimation period: 60 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 22
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
reading time points: 24, 48, and 72 hours - Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: intact skin of the dorsal trunk surface
- Type of wrap if used: 6 cm² gauze square placed directly on the intact test site per animal and directly held in place with tape. Gauze was then wrapped around the animal and secured with tape to keep the test material in contact with the skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The site was wiped free of test material with 0.9% saline and gauze
- Time after start of exposure: At the end of the exposure period
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 an 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- All three animals showed a very slight or slight erythema 1 hour after the test item application. Within 48 hours after removal of the patches the dermal effect were completely reversible.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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