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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-11-17 to 2010-02-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-{[(4R,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4R,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol
EC Number:
700-535-6
Cas Number:
1190931-34-0
Molecular formula:
C6F6H6O5
IUPAC Name:
2-{[(4R,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4R,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5R)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol; 2-{[(4S,5S)-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethan-1-ol
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): DIOX Alkohol
- Physical state: organic mono-constituent substance
- Analytical purity: 95.5%
- Impurities (identity and concentrations): dimer impurity 3.5%, DIOX FH impurity 1%
- Purity test date: no data
- Lot/batch No.: 107-31
- Expiration date of the lot/batch: 31 December 2020
- Stability under test conditions: no data
- Storage condition of test material: Ambient temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy S.r.l., 33049 San Pietro al Natisone (UD), Italy
- Age at study initiation: 6 to 8 weeks old
- Weight at study initiation: 164 to 196 grams
- Fasting period before study: not reported
- Housing: Individually caged (both during acclimatisation and study). Polycarbonate cages measuring 42.5x26.6x18 cm with stainless steel mesh lid and floor.
- Diet (e.g. ad libitum): 4 RF 18 ( ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 25 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours


IN-LIFE DATES: From: 2009-11-26 To: 2009-12-24

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal surfaces of the trunk
- % coverage: approximately 10% of body surface
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encircling the trunk of the animal with a length of elastic adhesive bandage, this forming a semi-occlusive barrier.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (328 - 388 mg per animal)
- Concentration (if solution): The liquid test item was used in the condition supplied.
- Constant volume or concentration used: yes


VEHICLE
no vehicle used
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality and morbidity: twice daily
Clinical signs : Day of dosing (on dosing, approximately 1, 2 and 4 hours after dosing). Daily thereafter (14 days).
Body weight : Allocation (Day-1), Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
no statistics applied

Results and discussion

Preliminary study:
not reported
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
no mortalities
Clinical signs:
other: none observed
Gross pathology:
No abnormalities were found at necropsy in the animals at termination of the study.
Other findings:
none reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results indicate that the test item, DIOX alcohol, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.
Executive summary:

The acute toxicity of DIOX alcohol was investigated following dermal administration of a single dose to the rat. The study followed the protocol according to OECD Guideline 402.

A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days all animals were killed and subjected to necropsy examination. No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals. No abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site.

These results indicate that the test item, DIOX alcohol, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.

European Directives concerning the classification, packaging and labelling of dangerous substances and mixtures would indicate the following:

Classification : Not required

Signal word : None indicated

Hazard statement : None indicated

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