Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Contribution à l'étude toxicologique de l'alcool n-heptylique
Author:
R. Truhaut
Year:
1974
Bibliographic source:
Archive des maladies Professionnelles de Medecine du Travail. 35, 4-5, Avril-Mai
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Purity>97%
- Name of test material (as cited in study report):n-heptanol-1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: non exposed eye
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h+48h+72h
Score:
1.16
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h+48h+72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24h+48h+72h
Score:
0.94
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24+48+72h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
n-heptanol-1 is considered as irritating to eyes.
Executive summary:

The potential of n-heptanol-1 to induce ocular irritation was evaluated in rabbits according to OECD (No. 405) guideline. A single dose of 0.1mL of the undiluted test item was instilled into the conjunctival sac of the eye of 6 rabbits. The eyes were not rinsed after administration of the test item.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. Mean scores calculated over 24, 48 and 72 hours were 0.22 for chemosis, 0.94 for redness of the conjunctiva, 0.0 for iris lesions and 1.16 for corneal opacity. We observed that the test item indiced slght opcity of the cornea with a slght irritation of the conjonctive. The irritation is at maximum at 72 hours and reverse progressively. 4/6 rabbits did not present signs of irritation after 7 days. Under these experimental conditions, n-heptanol-1 was irritant when administered by ocular route to rabbits.