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Toxicological information

Acute Toxicity: dermal

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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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
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
Name:
Unnamed
Type:
Constituent
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

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:
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.