2-butyloctan-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September until October 1986

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-butyloctan-1-ol

EC Number:

223-470-0

EC Name:

2-butyloctan-1-ol

Cas Number:

3913-02-8

Molecular formula:

C12H26O

IUPAC Name:

2-butyloctan-1-ol

Details on test material:

- Name of test material (as cited in study report): Isofol 12
no more details mentioned

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Chr. Leuschner & Co, Loehndorf, Germany
- Age at study initiation: approximately 7 months
- Weight at study initiation: 2.18 - 2.91 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Altromin 2023, ad libitum, supplied by Altromin GmbH, Lage, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 1 quarantine week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 5
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: treatment of the second eye with 0.9 % NaCl solution

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml

Duration of treatment / exposure:

single administration, in each animal the test article was introduced into the conjunctival sac of the left eyes, afterwards the eyelid was closed for 1 second. Unlimited exposure (not rinsed).

Observation period (in vivo):

7 days (readings 5, 15, 30 min, 1, 2, 4 h, 1, 2, 3 and 7 d after instillation)

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to Draize-Scheme (0-4)

TOOL USED TO ASSESS SCORE: slit lamp; treatment with Na-fluorescein, USP 24 hours after administration

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 78 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0.67
- Conjuntivae (Chemosis): 0
DESCRIPTION OF LESIONS: Slightly erythema and slightly increased secretion were observed 5 min after instillation, the maximum score was observed after 4 hours.
REVERSIBILITY: reversible within 7 days p.a.

Other effects:

none

Any other information on results incl. tables

Table 1: Irritant/corrosive response data at each observation time

Score at time point / Reversibility		Cornea	Iris	Conjunctivae	Chemosis
5 min		0 (3)	0 (3)	1 (3)	0 (3)
15 min		0 (3)	0 (3)	1 (3)	0 (3)
30 min		0 (3)	0 (3)	1 (3)	0 (3)
1 h		0 (3)	0 (3)	1 (3)	0 (3)
2 h		0 (3)	0 (3)	1 (3)	0 (3)
4 h		0 (3)	0 (3)	2 (1) / 1 (2)	0 (3)
24 h		0 (3)	0 (3)	2 (1) / 1 (1) / 0 (1)	0 (3)
48 h		0 (3)	0 (3)	1 (2) / 0 (1)	0 (3)
72 h		0 (3)	0 (3)	1 (1) / 0 (2)	0 (3)
7 d		0 (3)	0 (3)	0 (3)	0 (3)
Average 24, 48, 72 h		0	0	0.67	0
Reversibility *		c.	c.	c.	c.

 

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study 2-butyloctan-1-ol is slightly irritating to the eye.

Executive summary:

Based on the results of this study 2-butyloctan-1-ol is slightly irritating to the eye.