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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
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 405 (Acute Eye Irritation / Corrosion)
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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Supplier: Guangdong Medical Laboratory Animal Center [ certified animal number "SCXK (Gunagdong) 2008-0002"].
- Acclimatisation: Five days prior to the experiment in the opbservation room.
- Identification of animals: Tags marked with animal number and treatment details were attached to cages. Each animal was given a unique number.
- Body weight: 2.5 - 3.0kg
- Test Room: in the center
- Animal house condition: The test facility was an air-conditioned room with 12 hours artifical fluorescent light and 12 hours dark
- Temp range: 19~25°C
- Humidity Rabge: 40~70%
- Caging: Stainless steels grid rabbit cages were used, and the animals were housed individually.
- Water supply: Each cage was supplied with a stainless steel nozzle which would supply tap water in spots.
- Sanitation: Auto-flushing device was used to keep the condition clean.
- Food and Water: Standard pellet feed supplied by Guangdong Medical Laboratory Aniaml Center and tap water were provided to the animals
-Freq. of providing feed and drinking water: Both drinking water and feed were provided ad libitum.

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
- Known weight of 0.1mL of the test substance was administered to one eye of a rabbit and the opposite eye was applied as control (2/sex).
Duration of treatment / exposure:
- Following the dosing, the rabbits were observed for Eye Irritation on conjunctiva, iris and cornea at the 1st, 24th, 48th, 72nd hour and on the 4th , 7th day.
Observation period (in vivo):
- Following the dosing, the rabbits were observed for Eye Irritation on conjunctiva, iris and cornea at the 1st, 24th, 48th, 72nd hour and on the 4th , 7th day.
( The observation period can be prolonged to 21 days if lesion is not clear. )
Number of animals or in vitro replicates:
2 Male and 2 Female
Details on study design:
- Prep. of test substance: Raw substance was used.
- Test Procedure: both eyes of animal were exmained and identified to be normal before test. 0.1ml of test material was administered to one eye of a rabbit and the opposite eye was applied as the control. The eyes were kept unwashed until 24 hours later and readings were made at the 1st, 24th, 48th, 72nd hour, and on the 4th, 7th day post application. The observation period can be prolonged to 21 days if lesion is not clear. Weighted integral, total integrals, average of total integrals and average of the highest total integrals in the first 4 days were figured out, then the eye irritation and its grade were evaluated according to the criterion on the Guidelines for the Testing of Chemicals.
- Dose Level: one group was set with the dose of 0.1ml, and the opposuite eye of the rabbits was applied as the control. 2 male and 2 female animals were invovled.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
29.5
Reversibility:
fully reversible within: 7d
Remarks on result:
probability of moderate irritation
Remarks:
Medium(++, 5th Grade)

Any other information on results incl. tables

Eye irritation:one hour after the application, excrete, engorgement and edema in conjunctiva were found in all tested eyes. The injury in conjunctiva had differente severity, and some animals recovered after 72h~4d, while the rest on the 7th day. Engorgement in tested irs was found in a few animals on hour after the application, and recovered on the 7th day; while some were found in a few animals 24 hours after the application, and recovered 48 hours later. Most animals had nubecula in more than 3/4 areas of the tested cornea 24 hours after application. The nubecula in a few animals recovered 72 hours later, while the rest got better 72h~4d later, and recovered on the 7th day. No irritation was observed in the controlled eyes.

Index of the score: The average of the highest total integrals in the forst 4 days was 29.5; the average of the total integrals was ZERO on the 7th day, and more than half of the animals had the total integrals less-than-or-equal-to 10.

Applicant's summary and conclusion

Interpretation of results:
other: medium
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
The average of the highst total integrals in the first 4 days was 29.5; the average of total integrals was ZERO on the 7th day, and more than half of the animals had the total integrals less0than-or-equal-to 10.

Based on guidelines for the testing of chemicals, the irritancy potency of Ethyl Tetrahydrofurfuryl Ether to eyes is estimated to be MEDIUM (++, the 5th grade).