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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:
weight of evidence
Study period:
March 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecane-1,12-diol
EC Number:
227-133-9
EC Name:
Dodecane-1,12-diol
Cas Number:
5675-51-4
Molecular formula:
C12H26O2
IUPAC Name:
dodecane-1,12-diol
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: dr. Ivanovas gmbH, 7964 Kisslegg im Allgäu/Germany
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

- Temperature (°C): 22+- 2
- Humidity (%): 55 +- 10
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and served as a control
Amount / concentration applied:
0.1 g/animal and left eye
Duration of treatment / exposure:
3 of 6 rabbits until the eyes were examined and ocular reactions recorded at 1, 24, 48 and 72 hours
in 3 of 6 rabbits approx. 30 seconds after treatment the treated eye was flushed with physiological saline for about one minute.
Observation period (in vivo):
up to 21 days, unless the eye is normal at 72 hours, 7 or 14 days
Number of animals or in vitro replicates:
3/sex
Details on study design:
scoring according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
males/not rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
females/rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
males/not rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
females/rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
males/not rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
females/rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
males/not rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
females/rinsed
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
One our after treatment redness (grade 1) was observed in 2/3 males (not rinsed). In 3/3 males (not rinsed) discharge was observed one hour after treatment. No effects were observed in 3/3 females (rinsed) one our after treatment.
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

In an eye irritation study with the test substance performed according to OECD 405 on six rabbits (3/sex), the test substance induced no irritation when applied into the rabbit eye mucosa. No acute toxicological signs were observed.