Registration Dossier
Registration Dossier
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EC number: 205-745-7 | CAS number: 149-73-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1966
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Clipped dorsal rabbit skin was wrapped with impervious film (secured by tape). Test substance was introduced through an opening (which was then sealed). Animals immobilized in FDA-type wooden stocks for up to 60 min. or 6 hours, then fitted with collars for 24 hrs to prevent oral uptake. 14-day observation and necropsy.
- GLP compliance:
- no
- Test type:
- other: Observation of systemic effects and mortality in skin irritation study
- Limit test:
- no
Test material
- Reference substance name:
- Trimethyl orthoformate
- EC Number:
- 205-745-7
- EC Name:
- Trimethyl orthoformate
- Cas Number:
- 149-73-5
- Molecular formula:
- C4H10O3
- IUPAC Name:
- trimethoxymethane
- Details on test material:
- - Name of test material (as cited in study report): Trimetyl orthoformate TMOF
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): no data
- Used as received
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino, not otherwise specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: no data
- Type of wrap if used: impervious film, secured at each end with Elastoplast. Opening in the center back to introduce test substance, then closed with strip of adhesive
- 2-inch polyethylene collars to prevent oral uptake during first 24 hours (before washing)
- One experiment with 2250 mg/kg bw performed without occlusive wrap, loosely covered
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water, then dried
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
1) 2250 mg/kg bw (4.6 ml per animal, application site loosely covered)
2) 2250 mg/kg bw (5.9 ml per animal, application site wrapped with occlusive patch)
3) 3400 mg/kg bw (11.2 ml per animal, application site wrapped with occlusive patch)
- Concentration (if solution): 100% undiluted
- Constant concentration used: yes
VEHICLE
- none - Duration of exposure:
- 1) 55 minutes: 2250 mg/kg bw (application site loosely covered)
2) 1 hour: 2250 mg/kg bw (application site wrapped with occlusive patch)
3) 6 hours: 3400 mg/kg bw (application site wrapped with occlusive patch) - Doses:
- 2250 mg/kg bw (application site loosely covered, 55 min exposure)
2250 mg/kg bw (application site wrapped with occlusive patch, 1 hour exposure)
3400 mg/kg bw (application site wrapped with occlusive patch, 6 hours exposure) - No. of animals per sex per dose:
- 1 (sex not stated)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- None applied (1 animal per dose)
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- >= 3 400 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 6 hours exposure
- Mortality:
- None observed
- Clinical signs:
- other: None at 2250 mg/kg bw (1 hour exposure) Mild-moderate erythema on day one at 3400 mg/kg bw (6 hours exposure, occlusive); diminishing though 5 days No signs of systemic toxicity at any dose
- Gross pathology:
- No findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance does not meet GHS classification criteria for acute dermal toxicity.
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