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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:
other: see 'Remark'
Remarks:
performed according to an official method by a renowned institution using "Diäthylcarbonat", no info about purity, origin or batch of the test substance, no GLP, no control animals, in general good documentation of methodology and evaluation of results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Test for eye irritants", Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): "Diäthylcarbonat"
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Lot/batch No.: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: "Lippische Versuchstierzucht / Exertal 1"
- Sex: male
- Weight at study initiation: 2.3 kg (average)
- Housing: kept in single cages
- Diet ad libitum: "mümmel z"; English: "ssniff / Soest"
- Water ad libitum
- Acclimation period: 7-14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 microliter
Duration of treatment / exposure:
8 d (at no stage flushing of eye after substance was applied)
Observation period (in vivo):
8 d; times of observation, after application of test substance: 24 h, 48 h, 72 h, 8d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing/flushing: not done

SCORING SYSTEM:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Time point:
72 h
Score:
0
Irritant / corrosive response data:
Results of the test

(1)Cornea
(A) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(B) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(2)Iris
(A) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(3)Conjunctiva
(A) : 0, 0, 0, 0, 1, 1 after 24 h; 0, 0, 0, 0, 0, 1 after 48 h; 0 for all 6 animals after 72 h and 8 d
(B) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(C) : 0 for all 6 animals after 24, 48, 72 h and 8 d

24 h values, sums of a+b+c: 0, 0, 0, 0, 2, 2
48 h values, sums of a+b+c: 0, 0, 0, 0, 0, 2
72 h values, sums of a+b+c: 0, 0, 0, 0, 0, 0

Primary irritation value = (15*0 + 2 + 2 + 2) / 18 = 0.3
Classification: 0 – 10 = not irritating
On a scale of 0-110 for primary eye irritation, the substance has reached 0.3 in the present study and will therefore be classified as not irritating.

Any other information on results incl. tables

8d results not included in the calculation of irritation index. All values were zero.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: conclusion in study report
Conclusions:
The test substance diethyl carbonate was not irritating to the rabbits eye.