Registration Dossier
Registration Dossier
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EC number: 205-465-5 | CAS number: 141-17-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Oct 2012 - 19 Dec 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study. No signature.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- xxx_DRAFT REPORT_XXX
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- EC Number:
- 205-465-5
- EC Name:
- Bis(2-(2-butoxyethoxy)ethyl) adipate
- Cas Number:
- 141-17-3
- Molecular formula:
- C22H42O8
- IUPAC Name:
- bis(2-(2-butoxyethoxy)ethyl) adipate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: males: 8 - 9 weeks; females: 12 - 14 weeks
- Weight at study initiation: males: 231 - 250 g; females: 208 - 234 g
- Housing: individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 160812)
- Diet: Altromin 1324 maintenance diet for rats and mice (lot no. 1039), ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: not less than 10%
- Type of wrap if used: The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using aqua ad injectionem (Ampuva, lot no. 19FG30HA, expiry date: 06/2015)
- Time after start of exposure: 24 h
TEST MATERIAL
The test item was used as delivered by the sponsor. - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of dosing (once during the first 30 minutes and with special attention given during the first 4 hours post-dose) and once daily until the end of the observation period thereafter
- Frequency of weighing: on day 1 (prior to the application) and on days 8 and 15
- Necropsy of survivors performed: yes (in case of findings during gross pathological examination, the tissues were preserved for a possible histopathological evaluation)
- Other examinations performed: Primary Skin Irritation using the Draize Scoring System
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred throughout the study period.
- Clinical signs:
- other: No signs of systemic toxicity were observed throughout the study period. Signs of dermal irritation after a single dose application were noted in females only: scratches (2/5) on Days 7-11; desquamation (1/5) on Days 7-11; eschar (1/5) on Days 9-11. Howev
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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