3-methylpentane-1,5-diol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate OECD test method and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-methylpentane-1,5-diol

EC Number:

224-709-1

EC Name:

3-methylpentane-1,5-diol

Cas Number:

4457-71-0

Molecular formula:

C6H14O2

IUPAC Name:

3-methylpentane-1,5-diol

Specific details on test material used for the study:

- Name of test material (as cited in study report): 3-Methyl-1,5 pentanediol
- Physical state: clear, colorless liquid
- test substance recieved on (date): 1 July 1987
- Sample designation: 3-Methyl-1,5-pentanediol
- Purity: > 99%
- Stability under test conditions: the stability and absorption of the test substance were not determined
- Storage condition of test material: at ambient temperature
- Other: the test substance was administered as supplied by the sponsor

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: three New Zealand White rabbits (from Buckmaster, Henham, Hertfordshire and Froxfield Rabbits, Petersfield, Hampshire, England)
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: approx. 2,5 kg prior to treatment
- Housing: individually housed in metal cages
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet
- Water (e.g. ad libitum): tap water
- Acclimation period: acclimated to the laboratory environment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 19 per hr
- Photoperiod (hrs dark / hrs light): 12 hr light/ 12 hr dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 ml 3-methyl-1,5-pentanediol in a single dose installed into the lower everted lid of one eye

Duration of treatment / exposure:

Single treatment and eyes were not rinsed after administration of the test substance.

Observation period (in vivo):

Animals were observed for ocular reaction after 1 hr and 1, 2, 3, 4 and 7 days after instillation.

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage or conjunctional inflammation. A single dose of 0.1 ml of the test substance in its original form was instilled into the lower everted lid of one eye of each animal, after gently held together the eyelids for one second before releasing. The contralateral eye remained untreated and served as a control.

The eyes were examined 1 hr and 1, 2, 3, 4 and 7 days after instillation.



Grading and scoring of the ocular lesions were performed using the prescribed numerical scoring system as follows:

Corena
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1*
Easily discernible translucent areas, details of iris slightly obscured 2*
Nacreous areas, no details of iris visible, size of pupil barely discernible 3*
Opaque Cornea, iris not discernible through the oopacity 4*

Iris
Normal 0
Markedly deepned rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these 1*
or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
No reaction to light, haemorrhage, gross destruction (any or all of these) 2*

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individual vessels not easily discernible 2*
Diffuse, beefy red 3*

Chemosis
(refers to lids and/or nictitating membranes)
No swelling 0
Any swelling above normal (includes nictitating membranes) 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half-closed 3*
Swelling with lids more than half-closed 4*

* interpreted as a positive effect

Interpretation of results and classification of substance
The results obtained were evaluated taking into consideration the nature and the reversibility or irreversibility of the findings observed. Classification of the substance is based on the criteria laid down in: Regulation 1272/2008 EC, Annex I, table 3.3.2

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: see Remarks

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: see Remarks

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: see Remarks

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

All three animals gave a "positive" response. Temporary corneal opacities developed in all three animals. Slight, transient iridial inflammation was seen in one rabbit only. A diffuse, crimson-red colouration of the conjunctivae, seen in two animals, was accompanied by obvious swelling with partial eversion of eyelids in one animal. All effects were fully reversible after four to seven days after instillation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions described in this study report, 3-methyl-1,5-pentanediol was considered as non-irritant when administered by ocular route in rabbits.