Dodecane-1,12-diol

Eye irritation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

males/not rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

females/rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Remarks:

males/not rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

females/rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

males/not rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

females/rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

males/not rinsed

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

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.