Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The center has been assessed by China National Accreditation Services for Conformity Assessment (CNAS) and proved to be in compliance with CNAS/CL01:2006 'Accreditation Criteria for Testing and Calibration Laboratories (Identical to ISO/IEC17025: 2005 General Requirements for the competence of Testing Calibration Laboratories). The accreditation certificate number is CNAS L0238.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Remarks:
China National Accreditation Services for Conformity Assessment (CNAS) and proved to be in compliance with CNAS/CL01:2006 'Accreditation Criteria for Testing and Calibration Laboratories

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Clear colourless liquid
- Sample no: ZL0902374
- Soluble in water and plant oil
- Supplied by Thomas Swan & Co,. Ltd. and kept in its original container at room temperature in the Test substance Store Room.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
- Supplier: Guangdong Medical Laboratory Animal Center [certified animal number SCXK (Guangdong) 2008-0002].
- Number of animals used: 5 male and 5 female
- Number of groups: 2
- Body weight at start of experiment: 180-250g
- Identification of animals: Tags marked with animal group number and treatment detaisl were attached to cages. Each animal was given a unique number.
- Acclimatisation: 5 days prior to the experiment in the test room


- Test Room: In the Center
- Animal house condition: The test facility was an air-conditioned room with 12 hours artificial fluorecent light and 12 hours dark.
- Temp range: 20~25°C
- Humidity Range: 40~70%
- Caging: Stainless steel grid rat cages were used. Autoclaved clean dry corncob was used as the bedding material. Animals were housed in groups by sex in cages, and each cage contained 5 animals at most.
- Water bottle: Each cage was supplied with a polypropylene water bottle with a stainless steel nozzle.
- Sanitation: Bedding material and cages were changed daily.
- Food and Water: Standard pellet feed supplied by Guangdong Medical Laboratory Animal Center and sterile water were provided to the animals.
-Freq. of providing feed and drinking water: Both drinking water and feed were provided ad libitum.

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- An area of about 5 x 8cm2 on the back of animals was clipped free of hair. 24 hours later, the intact animals were selected to use. A known weight of the test substance was embrocated onto the hair-free site of the test rats.
Duration of exposure:
14 days
Doses:
One limit dose group (2500mg/kg) and one control group were set. 5 male and 5 female animals were involved in each group.
No. of animals per sex per dose:
5 Male and 5 Female
Control animals:
not specified
Details on study design:
- An area of about 5 x 8cmE2 on the back of animals was clipped free of hair. 24 hours later, the intact animals were selected to use. A known weight of the test substance was embrocated onto the hair-free site of the test rats. The rats were fasten in the stainless steel shelves for 24 hours, then the test sites were cleaned with warm water. Rats were observed for 14 days after the administration. The rats of control group were treated as the rats of test group but with no test material.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 500 mg/kg bw
Based on:
test mat.
Mortality:
No mortaility was oberserved in rats of limit dose group and control group throughout the observation period.
Clinical signs:
No obvious poisoning symptoms were found in animals of test group and control group in 24 hours' administration. in the 14-day observation period, no obvious poisoning symptoms were found in animals of all groups, except for weight losing in a few animals of test group.
Body weight:
The appreciable change in body weight gain was observed in rats. A few test female animals were found losing weight on the 7th day and growing slowly in the following period, but no difference in body weights between test or control group was found.
Other findings:
NECROPSY: No major gross abnormalities were found in animals of test group and control group at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute dermal LD50 of Ethyl Tetrahydrofurfuryl Ether supplied by Thomas Swan & Co,. Ltd for rst was considered as > 2500 mg/kg.b.w

Based on the guidelines for the Hazard Evaluation of New Chemical Substances, the acute dermal toxicity of Ethyl Tetrahydrofurfuryl Ether is estimated to be ACTUALLY NONTOXIC.