Registration Dossier
Registration Dossier
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EC number: 221-110-7 | CAS number: 3006-82-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- NA
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- tert-butyl 2-ethylperoxyhexanoate
- EC Number:
- 221-110-7
- EC Name:
- tert-butyl 2-ethylperoxyhexanoate
- Cas Number:
- 3006-82-4
- Molecular formula:
- C12H24O3
- IUPAC Name:
- tert-butyl 2-ethylhexaneperoxoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: H.A.R.E. Rabbits for Research, Hewitt, New Jersey or Kuiper's Rabbit Ranch, Gary, Indiana
Housing: rabbits were individually housed in hanging wire-mesh cages in temperature and humidity controlled quarters
Conditioning period: 13 days prior to study initiation
Diet: ad libitum
Water: ad libitum
Body weights prior to administration: 2300 to 2804 g
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of each rabbit
- % coverage: 20 - 30 % of the body surface
- Type of wrap if used: the application sites were wrapped with gauze bandaging and overwrapped with Saran Wrap. The entire application area was then wrapped with Several layers of 75 mm Elastoplast tape. A collar was also applied.
REMOVAL OF TEST SUBSTANCE
- 24 hours following application, the bandages and collars were removed and the test sites were washed with tepid tap water
- Duration of exposure:
- 24 hours
- Doses:
- 2.5, 5, 10 and 20 g/kg bw
- No. of animals per sex per dose:
- 2 animals per sex per dose (total: 8 animals)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: pharmaceutical signs, mortality, dermal irritation - Statistics:
- 95% Confidence limits
Results and discussion
- Preliminary study:
- No preliminary study
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 14 142 mg/kg bw
- 95% CL:
- > 7 071 - < 28 284
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 20 000 mg/kg bw
- 95% CL:
- > 10 000 - < 40 000
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 16 818 mg/kg bw
- 95% CL:
- > 11 892 - < 23 784
- Mortality:
- 3 animals (2 females, 1 male) died during the 14 day study period at a dosage level of 20 g.
- Clinical signs:
- other: NA
- Gross pathology:
- NA
- Other findings:
- NA
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Eight male and 8 female New Zealand White rabbits were used for this study. The rabbits were divided into 4 groups of 2 male and 2 female rabbits each. The test material was applied once only to the backs of the rabbits at the following dosage levels: 2.5, 5, 10 and 20 g/kg.
Based upon the data obtained, the acute dermal LD50 values and 95% confidence limits (CL) were estimated to be as follows:
male rabbits: 20 g/kg bw with 95%CL of 10 - 40 g/kg bw
female rabbits: 14.14 g/kg bw with 95%CL of 7.07 - 28.28 g/kg bw
Combined male and female rabbits: 16.82 g/kg with 95%CL of 11.89 - 23.78 g/kg - Executive summary:
Tert.-Butylperoxy- 2-ethylhexanoat was tested to eight male and 8 female New Zealand White rabbits were used for this study. The rabbits were divided into 4 groups of 2 male and 2 female rabbits each. The test material was applied once only to the backs of the rabbits at the following dosage levels: 2.5, 5, 10 and 20 g/kg.
Based upon the data obtained, the acute dermal LD50 values and 95% confidence limits (CL) were estimated to be as follows:
male rabbits: 20 g/kg bw with 95%CL of 10 - 40 g/kg bw
female rabbits: 14.14 g/kg bw with 95%CL of 7.07 - 28.28 g/kg bw
Combined male and female rabbits: 16.82 g/kg with 95%CL of 11.89 - 23.78 g/kg
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