Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-12-05 to 2009-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: COMMISSION REGULATION (EC) No 440/2008 of 30 May 2008, B.5. “Acute Toxicity Eye Irritation/Corrosion”.
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

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
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
One hour after the treatment, slight reddening of the conjunctivae and the sclerae was noted in all animals. Furthermore, slight swelling (chemosis) of the conjunctiva was observed in the male rabbit and slight discharge was noted in the treated eyes of all animals.
At the 24-hour reading, no abnormal findings were observed in the conjunctivae of the animals; only slight reddening of the sclerae was still noted in one animal. No abnormal findings were observed in the treated eye of any animal 48 hours after the treatment.
No staining produced by the test item of the treated eye was observed.
No corrosion of the cornea was observed at any of the reading times.
Other effects:
No mortality occurred.
No clinical signs were observed during the course of the study.
The body weights of all rabbits were considered to be within the normal range of variability.
No necropsy was performed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sorbitan caprylate is considered to be “not irritating” to the rabbit eye.
Executive summary:

The primary eye irritation potential of sorbitan caprylate was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. All individual mean scores were 0.00 for all three animals.

The instillation of sorbitan caprylate into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis, which were mostly present at the 1-hour reading. 24 hours after the treatment, no signs of eye irritation were observed in the conjunctivae of the animals. Furthermore, no abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Sorbitan caprylate is considered to be “not irritating” to the rabbit eye.