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EC number: 217-568-2 | CAS number: 1889-67-4
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2011-09-22 to 2011-11-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1,1'-(1,1,2,2-tetramethylethylene)dibenzene
- EC Number:
- 217-568-2
- EC Name:
- 1,1'-(1,1,2,2-tetramethylethylene)dibenzene
- Cas Number:
- 1889-67-4
- Molecular formula:
- C18H22
- IUPAC Name:
- (2,3-dimethyl-3-phenylbutan-2-yl)benzene
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: Approximately 8 weeks (males) and 12 weeks (females)
- Weight at study initiation: males: 271 - 288 g; females: 222 - 244 g
- Fasting period before study: no
- Housing: Single caging in Makrolon cages type III (37.5 cm x 21.5 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week
- Diet: Ssniff R/M-H maintenance diet for rats and mice (item V1534-300) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany
- Water: Tap water, from an automatic watering system, ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: Mean of 20.85 °C (continuous control and recording)
- Humidity: Mean of 41.49 % (continuous control and recording)
- Air changes: 12 per hour.
- Photoperiod: Artificial light from 6 a.m. to 6 p.m.
IN-LIFE DATES: From: 2011-10-11 To: 2011-10-25
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6.5 x 8 cm
- % coverage: 10 % of estimated body surface
- Type of wrap if used: semi-occlusive dressing (Fixomull Stretch, Fa. Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was wiped off using wet cellulose tissue
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: The amounts of the test substance were calculated and weighed for each individual using the body weights determined on the day of the administration
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed 0 - 0.5, > 0.5 - 1, > 1 - 2, > 2 - 4 and > 4 - 6 hours after administration of the test substance (p.a.) and then at least once a day for a total of 2 weeks.
Body weights were determined
• before administration.
• 7 days p.a.
• 14 days p.a.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: General findings: All animals did not show any clinical signs during the entire observation period. Observations of skin condition: Exposed skin was not found to be altered by the test substance.
- Gross pathology:
- No abnormal findings were made in the animals at terminal necropsy.
- Other findings:
- No noteworthy sex difference in the response to the test substance was derived from clinical observations or post-mortem findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post mortem examination at a dose of 2000 mg of the test substance per kg body weight. No mortality occurred.
- Executive summary:
The test item 1,1'-(1,1,2,2-tetramethylethylene)dibenzene was tested in an acute dermal toxicity study in rats according to OECD guideline 402 and EU method B.3. The test item was administered once topically on an area of approximately 6.5 cm x 8 cm on the dorsal thoracic region of 5 male and 5 female Sprague Dawley rats. The dose was 2000 mg per kg body weight. A cellulose patch with the calculated amount of the test substance on the surface and soaked with deionised water to get optimal contact with the skin, was applied to the test site and held in place by fixing marginally with non-irritating tape. The test site was covered by a semi-occlusive dressing. The duration of the exposure was 24 hours. No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post-mortem examination at a dose of 2000 mg of the test substance per kg body weight. No mortality occurred. Therefore, the LD50 dermal was estimated to be > 2000 mg /kg body weight.
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