Decane-1,2-diol

Eye irritation

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: A guideline study conducted in accordance with OECD test guideline 405 and to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Decane-1,2-diol

EC Number:

214-288-2

EC Name:

Decane-1,2-diol

Cas Number:

1119-86-4

Molecular formula:

C10H22O2

IUPAC Name:

decane-1,2-diol

Test material form:

other: white solid

Details on test material:

- Name of test material (as cited in study report): 1,2-decanediol
- CAS number: 1119-86-4
- EC number: 214-288-2

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source:David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: Twelve to sixteen weeks old.
- Weight at study initiation: Weight range of 2.0 to 3.5 kg.
- Housing: The animal was housed in a suspended metal cage
- Environmental enrichment: wooden chew blocks and cardboard fun tunnels
- Diet (e.g. ad libitum): Free access to food
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL - approximately 74mg

Duration of treatment / exposure:

21 days

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

One

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: According to Draize Scale for Scoring Ocular Irritation at 1 hour, 24, 48 and 72 hours with additional observations at 27 and 21 days

TOOL USED TO ASSESS SCORE: Standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 hours

Score:

ca. 1

Max. score:

1

Reversibility:

not fully reversible within: 21

Remarks on result:

other: individual scores at the three time points were 1, 1, and 1 - vacularisation of cornea still evident after 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 hours

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 14

Remarks on result:

other: scores at the three time points were 1, 1 and 1

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 hours

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible within: 14

Remarks on result:

other: scores at the three time points were 2, 2 and 2

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: Mean of scores at 24, 48 and 72 hours

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 14

Remarks on result:

other: scores at the three time points were 2, 1 and 1

Irritant / corrosive response data:

Scattered or diffuse corneal opacity was noted in the treated eye one hour after treatment and at subsequent 24, 48, 72-hour, 7, 14 and 21-day observations. Vascularisation of the cornea with a generalised in growth of vessels for approximately 2 to 3 mm was noted in the treated eye at the 7, 14 and 21-day observations.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48, 72-hour and 7-day observations.
Moderate conjunctival irritation was noted in the treated eye one hour alter treatment and at the 24, 48, 72-hour and 7-day observations.
The corneal vascularisation noted in the treated eye was considered to be irreversible.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: other: EU CLP

Conclusions:

The test material produced irreversible ocular damage and was considered to be a Category 1 eye irritant (irreversible effects on the eye) and requires the Hazard Statement H318 "Causes serious eye damage"

Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following: a) OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and b) Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation).

A single application of the test material to the non-irrigated eye of one rabbit produced irreversible effects. Reactions included scattered or diffuse corneal opacity, iridial inflammation, moderate conjunctival irritation and vascularisation of the cornea with a generalised ingrowth of vessels for approximately 2 to 3 mm.

The test material produced irreversible ocular damage and was considered to be a Category 1 eye irritant (irreversible effects on the eye) and requires the Hazard Statement H318 "Causes serious eye damage".