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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 10 June 1988 and 17 June 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with OECD Guidelines and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guidelines for Testing of Chemicals
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Pamplefleur
IUPAC Name:
Pamplefleur
Test material form:
other: clear colourless liquid
Details on test material:
Compound Description: 88-212-01 - clear colorless liquid
Lot No.: Not applicable
Base Factor: Not applicable
Amount Submitted: 202.07 grams (material and container)
Date submitted: June 2, 1988
Special Handling Instructions: Standard precautions
Analysis of Purity: The identity, purity, strength and stability of the test article are the responsibility of the sponsor.
Stability: There was no apparent change in the physical state of the test article during administration

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species: Rabbit
Strain: Albino New Zealand White
Supplier (Source): Camm Research, Wayne, New Jersey
Sex: Male and female
Age at Initiation: Healthy adult animals
No. on Study: Four ( 4 ) (two male and two female)
Method an Justification of Randomizotion: Stratification by sex, body weight and apparent good health.
Acclimation Period: Five (5) days
System of Identification: Cages marked with an animal group number and dose level. Rabbits were ear tagged.

Research Facility Registration: U.S.D.A. Registration No. 23-107 under the Animal Welfare Act 7 4: se 2131 et
Animal Rooms: Separate isolation by test system.
Light cycle - 12 hours light, 12 hours dark.
Temperature/Humidity - Maintained at a temperature of 20°C ± 3°C and a humidity of 30 to 70%.
Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
Sanitization: Waste material was removed twice weekly. Cages and feeders were sanitized every two weeks.
Food: Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
Food Analysis: There were no contaminants that were reasonably expected to be present in the dietary material known to be capable of interfering with the purpose or conduct of the study.
Water Analysis: Availability - fresh tap water, ad libitum. Water is monitored for contaminants at periodic intervals according to Standard Operating Procedure PH-018.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, which remained untreated, served as a control.
Amount / concentration applied:
0.1 ml/eye
Duration of treatment / exposure:
Up to 1 hour
Observation period (in vivo):
7 Days
Number of animals or in vitro replicates:
4
Details on study design:
Rationale for Test System: A variety of experimental animals have been used, but i t is recommended that testing be performed using healthy adult albino rabbits.
Compound Preparation: Dosed as received.
Rationale for Dose Selection: According to EPA Federal Register, Vol. 50, No. 188, Friday, September 27, 1985, and OECD Guidelines for Testing of Chemicals, adopted: 24 Feb 87.
Dose Administration: 0.1 ml/eye
Vehicle: Not applicable
Route of Administration: The test article was administered directly into the eye.
Rationale for Route of Administration: To evaluate the irritant potential of the test article on the eye.
Frequency and Duration of Administration: Once (1)
No. and description of Animals Per Dose Group: Four (4) (two males and two females)
No. and Code of Dose Group: Rabbit No. 8586-8589, Treatment 0.1 ml/right eye
Length of Study: Seven (7) days
Method of Study Performance: Both eyes of each experimental animal provisionally selected for testing were examined within 24 hours prior to testing by the same procedure used during the test examination. Animals showing eye irritation, ocular defects o r pre-existing corneal injury were not
used. The test substance was placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball.
The lids were then gently held together for about one second in order to limit loss of the material. The other eye, which remained untreated, served as a control.
Type and Frequency of Test, Analysis, and Measurements to be Made: The eyes were examined at 1, 24, 48 and 72 hours and on Day 7 after treatment. The grades of ocular reaction were recorded at each examination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal: 8586 male
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal: 8587 male
Time point:
other: 24, 48 and 72 hours
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal: 8588 female
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Remarks:
animal: 8589 female
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal: 8586 male
Time point:
other: 24, 48 and 72 hours
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal: 8587 male
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal: 8588 female
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal: 8589 female
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal: 8586 male
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effect noted
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal: 8587 male
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effect noted
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal: 8588 female
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effect noted
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal: 8589 female
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effect noted
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal: 8586 male
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effect noted
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal: 8587 male
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effect noted
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal: 8588 female
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effect noted
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal: 8589 female
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effect noted
Irritant / corrosive response data:
Positive ocular scores were recorded at the 1, 24, 48 and 72 hour observation periods. No positive scores were observed on Day 7 and the study was terminated at the sponsor's request.

Any other information on results incl. tables

The pH of the test article was not presented. In view of the chemical structure no strong reactivity is expected (e.g. absence of acidic or basic groups).

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
In an OECD TG 405 test and using CLP criteria it is an eye irritant, while using the DSD criteria the substance is not an eye irritant.
Executive summary:

In an OECD TG 405 study, 0.1 ml Pamplefleur, was instilled into the right eye of each of four rabbits. The cornea and iris scores were all zero. The conjunctivae scores were maximum 2.3 in 2/3 animals. In the two other animals this score was maximum 1. These conjuntivae effects were reversible within 7 days in 3/4 animals. the chemosis scores were maximum 1.6 and fully reversible within 7 days.