1,1-dimethylheptanethiol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-10 to 2012-02-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified reliable without restriction. The study followed GLP and adhered to OECD Guideline 405 recommendations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,1-dimethylheptanethiol

EC Number:

246-896-9

EC Name:

1,1-dimethylheptanethiol

Cas Number:

25360-10-5

Molecular formula:

C9H20S

IUPAC Name:

3,5-dimethylheptane-3-thiol

Test material form:

other: Clear liquid

Details on test material:

- Name of test material (as cited in study report): Tert-Nonanethiol
- Substance type: Aliphatic Thiol
- Physical state: Liquid
- Analytical purity: 97.58%
- Lot/batch No.: 2011-11-1629
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature and in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Commercial Breeder (name not reported)
- Age at study initiation: 19 to 20 weeks of age
- Weight at study initiation: 3.40 to 3.53 Kg
- Housing: individually in a plastic cage with perforated floors
- Diet (e.g. ad libitum): 125 g of a standard laboratory rabbit diet per day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Five weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 20°C
- Humidity (%): 40 to 70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: Not reported

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

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

Duration of treatment / exposure:

Single exposure followed by 72 hours observation period

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: See 'Any other information on materials and methods' section below

TOOL USED TO ASSESS SCORE: ophthalmoscope or pencil beam torch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, and 72 hour

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, and 72 hour

Score:

0

Max. score:

4

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, and 72 hour

Score:

0

Max. score:

4

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, and 72 hour

Score:

0

Max. score:

4

Irritant / corrosive response data:

Slight discharge was apparent in the treated eye of each animal one hour after instillation and the animals were overtly normal from 24 hours after instillation. Instillation of the test material gave rise to no or practically no initial pain response.

Other effects:

There was no sign of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Table 1. means 24, 48, and 72 hour scores for the ocular reactions

24-, 48-, and 72 hour scores	Corneal Opacity	Iridial Lesions	Conjunctiva
			Redness	Chemosis
Mean for 3 animals	0	0	0	0
EC Category 1 trigger values*	≥3	>1.5
EC Category 2 trigger values*	≥1	≥1	≥2	≥2

* Classification triggered if any value is attained by two or more animals.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Tert-nonanethiol is not considered to be an ocular irritant based on the results obtained in this study in the rabbit.

Executive summary:

In an ocular irritation study, three New Zealand White rabbits were administered a single ocular dose (0.1 mL) of tert-nonanethiol and observed for 72 hours after instillation. The test material was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated. The treated eyes were not irrigated or rinsed after instillation.

 

There was no sign of toxicity or ill health in any rabbit during the observation period. Slight discharge was apparent in the treated eye of each animal one hour after instillation and the animals were overtly normal from 24 hours after instillation. Instillation of the test material gave rise to no or practically no initial pain response.

 

Tert-nonanethiol did not produce any ocular irritation in this study.