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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:
December 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: - missing test substance characterisation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Hazardous Substances, Part. 191, section 12, FDA, Washington 1965
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Octyl-1-dodecanol
- Substance type: pure active compound
- Physical state: liquid
- Lot/batch No.: 03508
- Expiration date of the lot/batch: January 1, 2011
- Storage condition of test material: room temperature, protected from moisture and light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: laboratory breed
- Age at study initiation: not mentioned
- Weight at study initiation: 2.3 - 2.8 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: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 60 ± 3
- 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):
4 days (oberservations after 5, 15, 30 min, 1, 2, 4 h, 1, 2, 3 and 4 d)
Number of animals or in vitro replicates:
6 (3 male and 3 female)
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:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.33
- Conjuntivae (Chemosis): 0.0
DESCRIPTION OF LESIONS: In the area of the conjunctiva observed a slight erythema after 5 min, the maximum score was 1 hour after application.
REVERSIBILITY: reversible within 48 h after application
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 (6)

0 (6)

1 (6)

0 (6)

15 min

0 (6)

0 (6)

1 (6)

0 (6)

30 min

0 (6)

0 (6)

2 (5) / 1 (1)

1 (5) / 0 (1)

1 h

0 (6)

0 (6)

2 (6)

1 (6)

2 h

0 (6)

0 (6)

2 (6)

1 (6)

4 h

0 (6)

0 (6)

2 (3) / 1 (3)

0 (6)

8 h

0 (6)

0 (6)

2 (2) / 1 (4)

0 (6)

24 h

0 (6)

0 (6)

1 (6)

0 (6)

48 h 0 (6) 0 (6) 0 (6) 0 (6)
72 h 0 (6) 0 (6) 0 (6) 0 (6)
4 d 0 (6) 0 (6) 0 (6) 0 (6)
 Average 24, 48, 72 h 0 0 0.33 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 result of this study, 2-Octyldodecan-1-ol is slightly irritating to the eyes.
Executive summary:

Based on the result of this study, 2-Octyldodecan-1-ol is slightly irritating to the eyes.