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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Followed Appraisal for the saftey of chemicals in food, drugs and cosmetics, FDA and Draize 1959
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
EC Number:
947-436-6
Molecular formula:
not applicable for UVCB
IUPAC Name:
Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 2.4-2.6 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 45-55
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% in water
Observation period (in vivo):
1, 2, 8 h after treatment, as well as 1, 2, 3, 4, 5, 6, and 7 d after treatment
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
19.3
Max. score:
110
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of weak irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
14.2
Max. score:
110
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of weak irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Accoridng to the effects observed in the eye of the rabbit the test substance is considered a weak irritant to eyes.
Executive summary:

The substance was applied to the eye of albino rabbits. Slight effects were observed (cornea was unaffected, iris showed slight effects, Conjunctivae showed chemosis and secretion).