Isotridecan-1-ol

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

Isotridecan-1-ol

EC Number:

248-469-2

EC Name:

Isotridecan-1-ol

Cas Number:

27458-92-0

Molecular formula:

C13H28O

IUPAC Name:

2-methyldodecan-1-ol

Details on test material:

- Name of test substance: Tridecanol N
- Degree of purity: 99.9 %
- Physical state / appearance: Liquid / colorless-clear
- Lot/batch No.: continuous production
- Homogeneity: Homogeneous by visual inspection
- Storage conditions: Room temperature, covered with N2
- Stability under test conditions: The stability of the test substance in the vehicle for a time period of 4 hours was confirmed by analysis.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 4 months
- Weight at study initiation: 3.07 - 3.20 kg
- Housing: Single housing
- Diet: Kliba-Labordiaet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

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

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

72 h (2 animals), 7 days (1 animal)

Number of animals or in vitro replicates:

3 (2 females and 1 male)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24 - 48 - 72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: cornea opacity (score 1) only observed in one animal

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h - 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal 1-3)

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: chemosis (score 1) observed in 3 animals

Irritant / corrosive response data:

Moderate conjunctival redness (grade 2), slight conjunctival chemosis (grade 1) and moderate to severe discharge (grade 2 - 3), were observed in all animals 1 hour after application.

Slight conjunctival redness (grade 1) was noted in 1 animal 24 and 48 hours after application. Moderate conjunctival redness (grade 2) was observed in 2 animals 24 hours after application and decreased to slight conjunctival redness (grade 1) after 48 hours after application. In one of these two animals slight conjunctival redness persisted up to 72 hours after application. Additionally slight corneal opacity (grade 1) and loss of corneal tissue was noted in this animal 48 and 72 hours after application.

The ocular reactions were reversible in 2 animals after 72 hours and in 1 animal within 7 days after application.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0 .7 and 0 .0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.7, 1.3 and 1.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.


INDIVIDUAL OCULAR EXAMINATIONS AND MEAN VALUES


Readings Animal Cornea Iris Conjuntiva Additional Findings
Opacity Area of Redness Chemosis Discharge
cornea
involved
-------------------------------------------------------------------------------------------------------------------
1h 1 0 0 0 2 1 2
1h 2 0 0 0 2 1 3
1h 3 0 0 0 2 1 2
-------------------------------------------------------------------------------------------------------------------
24h 1 0 0 0 1 0 0
24h 2 0 0 0 2 0 0
24h 3 0 0 0 2 0 0
-------------------------------------------------------------------------------------------------------------------
48h 1 0 0 0 1 0 0
48h 2 1 1 0 1 0 0 LC
48h 3 0 0 0 1 0 0
-------------------------------------------------------------------------------------------------------------------
72h 1 0 0 0 0 0 0 SD
72h 2 1 1 0 1 0 0 LC
72h 3 0 0 0 0 0 0 SD
-------------------------------------------------------------------------------------------------------------------
7d 2 0 0 0 0 0 0
-------------------------------------------------------------------------------------------------------------------
Mean 1 0.0 0.0 0.7 0.0
Mean 2 0.7 0.0 1.3 0.0
Mean 3 0.0 0.0 1.0 0.0
-------------------------------------------------------------------------------------------------------------------
Mean 0.2 0.0 1.0 0.0
-------------------------------------------------------------------------------------------------------------------

Explanation of findings:
LC = Loss of corneal tissue
SD = Study discontinued because the animal was free of findings

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met