Reaction products of alkenes, C10-C14-(branched and linear), C12-rich, with hydrogen and carbon monoxide

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: GLP 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:

Alcohols, C11-14-iso-, C13-rich

EC Number:

271-235-6

EC Name:

Alcohols, C11-14-iso-, C13-rich

Cas Number:

68526-86-3

Molecular formula:

Unspecified

IUPAC Name:

Alcohols, C11-14-iso-, C13-rich

Details on test material:

- Name of test material: Tridecanol A

- Physical state / appearance: Liquid / colorless - clear

- Degree of purity / content: 99.95 area-%

- Homogeneity: The test substance was homogeneous by visual inspection.

- Batch No.: from continuous production

- Test substance No.: 01/0324-1

- Stability: The stability was determined by reanalysis.

- Storage conditions: Room temperature, exclusion of oxygen (under nitrogen)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Strain / quality: New Zealand white A1077 INRA (SPF);

- Origin: Centre Lago S.A., 01 540 Vonnas, France;

- Age at the beginning of the study: about 4 months;

- Body weight range at the beginning of the study: 3.14 - 3.19 kg;

- No. of animals per cage: Single housing;

- Type of diet: Kliba-Labordiet, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 g/animal per day);

- Watering: Tap water ad libitum;

- Acclimatization period: At least 5 days before the beginning of the study.

- Housing conditions:
Temperature: 20 - 24°C;
Relative humidity: 30 - 70%;
Illumination period: 12 h light (6.00 am - 6.00 pm), 12 h darkness (6.00 pm - 6.00 am);

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:

24 hours

Observation period (in vivo):

14 days (animal No. 1), 7 days (animal Nos. 2, 3)

Number of animals or in vitro replicates:

3 (2 females, 1 male)

Details on study design:

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


Scoring system:
according to OECD 405 / Draize

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 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: opacity was only observed in animal No. 2

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

other: 24 - 48 - 72 hours

Score:

0.1

Max. score:

2

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: iritis was only observed in animal No. 2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

other: 24 - 48 - 72 hours

Score:

1.4

Max. score:

3

Reversibility:

fully reversible within: 7 days (animals Nos. 2 and 3), 14 days (animal No. 1)

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

(animal 1 - 3)

Time point:

other: 24 - 48 - 72 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 24 hours (animal Nos. 1 and 3), 72 hours (animal No. 2)

Irritant / corrosive response data:

Moderate conjunctival redness (grade 2), slight conjunctival chemosis (grade 1) and moderate discharge (grade 2) were observed in all animals 1 hour after application. Moderate conjunctival redness persisted in all animals until 24 hours and in 1 animal up to 48 hours. In 2 animals moderate conjunctival redness decreased to slight (grade 1) at 48 hours. After 72 hours all animals showed slight conjunctival redness, which persisted in 1 animal until day 7. Slight conjunctival chemosis (grade 1) persisted in 1 animal up to 48 hours after application, slight discharge (grade 1) was seen in this animal up to 24 hours. Moderate iritis (grade 1) was observed in 1 animal 24 hours after application. The same animal showed slight corneal opacity (grade 1) from 48 hours up to 72 hours after application and small retraction in the eyelid from 24 hours up to 7 days. The ocular reactions were reversible in 2 animals within 7 days and in 1 animal after 14 days. 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, 0.3 and 0.0 for iris lesions, 1.3, 1.7 and 1.3 for redness of the conjunctiva and 0.0, 0.7 and 0.0 for chemosis.

Any other information on results incl. tables

Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means.

Animal Number	Evaluation Interval	Corneal Opacity	Area of Corneal Opacity	Iris	Conjunctivae
					Red	SW	DI
1 2 3	1 hour	0 0 0	0 0 0	0 0 0	2 2 2	1 1 1	2 2 2
1 2 3	24 hours	0 0 0	0 0 0	0 1 0	2 2 2	0 1 0	0 1 0
1 2 3	48 hours	0 1 0	0 1 0	0 0 0	1 2 1	0 1 0	0 0 0
1 2 3	72 hours	0 1 0	0 1 0	0 0 0	1 1 1	0 0 0	0 0 0
1 2 3	7 days	0 0 0	0 0 0	0 0 0	1 0 0	0 0 0	0 0 0
1	14 days	0	0	0	0	0	0
1 2 3	ME	0.0 0.7 0.0		0.0 0.3 0.0	1.3            0.0 1.7            0.7 1.3            0.0
	ME	0.2		0.1	1.4            0.2

Animal 2 showed small retraction in the eyelid from 24 hours up to 7 days.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information