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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
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
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.