Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06/08/1987 - 06/28/1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP run study according to EPA Guideline OPP 81-4

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes
Remarks:
40 CFR 792.35 (b) (6) (7)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
clear, colorless liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Young adult New Zealand White rabbits (4M and 2F; 2229- 2404 g B Wt M and 2255 & 2455g B Wt F) were procured, maintained individually in screen-bottom cages in temperature and humidity controlled quarters (19-21ºC and 39-61% RH), provided access to water ad libitum and a measured amount of Purina High fiber Rabbit Chow and held for an acclimation period of at least 7 days. Animal husbandry and housing at HLA comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals."

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye used as control
Amount / concentration applied:
0.1mL placed on the everted lower lid of one eye.
Duration of treatment / exposure:
The eyes of the rabbits remained unflushed.
Observation period (in vivo):
The treated eyes were observed for ocular irritation at 1, 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Each rabbit received 0.1mL of the test material placed on the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The upper and lower lid were gently held together for one second to prevent loss of material and then released. The eyes of the rabbits remained unflushed. The treated eyes were observed for ocular irritation at 1, 24, 48 and 72 hours after treatment. At the 72 hour reading, sodium fluorescein was used to aid in revealing corneal injury. Irritation was graded and scored according to the Draize technique. Animals were weighed just prior to the test material administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 H
Score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 H
Score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 H
Score:
0.44
Reversibility:
not fully reversible within: 72 H
Irritant / corrosive response data:
The test material produced reversible slight to moderate conjuctival irritation during the study.

Any other information on results incl. tables

No pain response was elicited from any animal following instillation of the test material.

Blanching of the conjunctiva was seen in 2 of the 6 animals at 1 hour.

No corneal or iridal irritation was observed in any animal during the study period.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information reversible Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material produced reversible slight to moderate conjuctival irritation during the study.
Executive summary:

Isodecyl Benzoate was evaluated for its primary skin irritation potential in male and female rabbits. Young adult New Zealand White rabbits (4M and 2F; 2229- 2404 g B Wt M and 2255 & 2455g B Wt F) were procured, maintained individually in screen-bottom cages in temperature and humidity controlled quarters (19-21ºC and 39-61% RH), provided access to water ad libitum and a measured amount of Purina High fiber Rabbit Chow, and held for an acclimation period of at least 7 days. Each animal was assigned a unique identification number and was identified with a metal ear tag. Animal husbandry and housing complied with standards outlined in the "Guide for the Care and Use of Laboratory Animals." Animals were weighed just prior to the test material administration. Each rabbit received 0.1mL of the test material placed on the everted lower lid of one eye, with the contralateral eye serving as the untreated control. The upper and lower lid were gently held together for one second to prevent loss of material and then released. The eyes of the rabbits remained unflushed. The treated eyes were observed for ocular irritation at 1, 24, 48 and 72 hours after treatment. At the 72 hour reading, sodium fluorescein was used to aid in revealing corneal injury. Irritation was graded and scored according to the Draize technique.

 

The test material produced reversible slight to moderate conjunctival irritation during the study.