Registration Dossier
Registration Dossier
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EC number: 212-572-0 | CAS number: 827-52-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- Cyclohexylbenzene
- EC Number:
- 212-572-0
- EC Name:
- Cyclohexylbenzene
- Cas Number:
- 827-52-1
- Molecular formula:
- C12H16
- IUPAC Name:
- cyclohexylbenzene
- Details on test material:
- - Name of test material (as cited in study report): MCS-2805
- Lot No.: ABDR-016
- Description: clear colourless liquid
- Composition: cyclohexylbenzene: 92.6%; bicyclohexyl: 6.9%
- Date received: 2001-08-06
- Storage conditions: room temperature, in the dark
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: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2-3 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum (LABDIET 5322, PMI Nutrition International, Nottingham, UK)
- Water: ad libitum
- Acclimation period: ≥ 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥ 15
- 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: approximating to 10% of the total body surface area
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the bandage was carefully removed and the treated skin decontaminated to remove any residual test material
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 2.15 ml/kg - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. After removal of the dressings and subsequently once daily for 14 days, the test sites were examined and the presence or absence of any dermal irritation recorded accordingly.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No
- Clinical signs:
- other: No signs of systemic toxicity
- Gross pathology:
- No abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the New Zealand White rabbit was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test material in the New Zealand White rabbit. The study was carried out according to OECD guideline 402.
A group of ten animals (5 males and 5 females) was given a single 24 -h semi-occluded dermal application of undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
No deaths and no signs of systemic toxicity were observed. Signs of skin irritation noted were well-defined erythema, very slight to slight oedema, loss of skin elasticity and flexibility, light brown discolouration of the epidermis, superficial cracking of the epidermis, crust formation, a hardened light brown coloured scab, slight desquamation and fissuring. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the New Zealand White rabbit was found to be greater than 2000 mg/kg bodyweight.
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