Registration Dossier

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:
Not reported. Test material was received 12 July 1977, study report was finalised 7 December 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was placed into the cupped conjunctival sac of the right eye of 3 rabbits following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a wash out. The treated eyes were examined for irritation 24, 48, 72 hours and 7 days following instillation of the test material.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material identified as 'Firemaster 100 Lot 53 77.902' and was received as a fine white powder.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
Kuiper's Rabbit Ranch, Gary, Indiana.

- Age at study initiation:
Not reported.

- Weight at study initiation:
2003-2220 grams

- Housing:
The rabbits were individually housed in metal metabolism cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum):
Purina Rabbit Chow were available ad libitum.

- Water (e.g. ad libitum):
ad libitum

- Acclimation period:
Not reported.

ENVIRONMENTAL CONDITIONS
The animals were maintained in accordance with the recommendations contained in H.E.W. Publication No. 74-23 (N.I.H.) entitled "Guide for the Care and Use of Laboratory Animals".



IN-LIFE DATES: From: Day 1 To: Day 7

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
100 mg

- Concentration (if solution):
Not applicable.

VEHICLE
None.
Duration of treatment / exposure:
The rabbits received 100 milligrams of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a washout.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males and 3 females.
Details on study design:
SELECTION OF TEST ANIMALS:
Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.

REMOVAL OF TEST SUBSTANCE:
- Washing (if done):
No washing conducted.

- Time after start of exposure:
Not applicable.

SCORING SYSTEM:
Draize, J. H., Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetic, Assoc. Food and Drug Officials of the U. S., Austin, Texas; 1959, p. 51, Modified according to revision in 1964. Edited by A. J. Lehman.

Cornea
(A) Opacity-degree of density (area most dense taken for reading)
No opacity: 0
Scattered or diffuse area, details of iris clearly visible: 1
Easily discernible translucent areas, details of iris
slightly obscured: 2
Opalescent areas, no details of iris visible, size of pupil
barely discernible: 3
Opaque, iris invisible: 4

(B) Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters up to whole area 4

Iris
Normal: 0
Folds above normal, congestion, swelling, circumcorneal
injection (any or all of these or combination of any there of)
iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, hemorrhage, gross destruction (any or
all of these): 2

Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae exluding cornea and iris)
Vessels normal: 0
Vessels definitely injected above normal: 1
More diffuse, deeper crimson red, individual
vessels not easily discernible: 2
Diffuse beefy red: 3

(B) Chemosis
No swelling: 0
Any swelling above normal (includes
nictitating membrane): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids about half closed to
completely closed: 4

(C) Discharge
No discharge: 0
Any amount different from normal (does not
include small amounts observed in inner
canthus of normal animals): 1
Discharge with moistening of the lids and hairs
just adjacent to the lids: 2
Discharge with moistening of the lids and hairs,
and considerable area around the eye: 3

ASSESSMENT SCHEDULE:
The treated eyes were examined in accordance with the following schedule, 24 48, 72* hours and 7 days* following instillation of the test material.
*Sodium fluorescein examinations were conducted at these intervals. After grading the eye reaction, one drop of sodium fluorescein was instilled directly onto the corneal surface of each rabbit. After a few seconds, excess stain was flushed from the corneal surface with distilled water and the eyes examined with ultraviolet light.

TOOL USED TO ASSESS SCORE: Sodium fluorescein and ultra violet light.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 48 hours
Score:
0.2
Max. score:
0.5
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
mean
Time point:
other: 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hous
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
0.1
Max. score:
0.5
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0.1
Max. score:
0.5
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Time point:
other: 48 hours
Score:
0.2
Max. score:
0.5
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Discharge
Basis:
mean
Time point:
other: 72 hours
Score:
0.1
Max. score:
0.5
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
No animals were observed with Cornea or Iris effects at any of the observation periods.

2 animals showed very slight redness to the conjuctivae (0.5) at the 48 hour observation and also at the 72 hour observation a further 1 animals also showed very slight redness to the conjuctivae (0.5) at the 72 hour observation. 3 animals showed no redness to the conjuctivae at any observation. All animals appeared normal at the 7 day observation.

1 animals showed very slight chemosis (0.5) at the 48 hour and 72 hour observations, all animals appeared normal at the 7 day observation.

2 animals showed very slight discharge of the conjuctivae (1) at the 24 hour observation, one animal appeared normal at the 48 hour observation while the other showed reduced discharge (0.5). A further 1 animal also showed very slight discharge of the conjuctivae (0.5) at the 48 and 72 hour observation. All animals appeared normal at the 7 day observation.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results obtained do not allow the registered substance to be classified as an irritant to the eye according to the criteria set out in 47/458/EEC.
Executive summary:

Three male and three female New Zealand White rabbits were used for this study.

Prior to test material administration, the eyes of each rabbit were examined with ultraviolet light following instillation of one drop of a 2.0 percent sodium fluorescein solution. Rabbits exhibiting corneal lesions were discarded.

The rabbits received 100 milligrams of the test material. The test material was placed into the cupped conjunctival sac of the right eye of each rabbit following which the eyelids were gently held together for one second. The left eye served as the untreated control for each rabbit. None of the rabbits received a wash out.

The treated eyes were examined in accordance with the following schedule, 24 48, 72* hours and 7 days* following instillation of the test material.

The results obtained do not allow the registered substance to be classified as an irritant to the eye according to the criteria set out in 47/458/EEC.

*Sodium fluorescein examinations were conducted at these intervals. After grading the eye reaction, one drop of sodium fluorescein was instilled directly onto the corneal surface of each rabbit. After a few seconds, excess stain was flushed from the corneal surface with distilled water and the eyes examined with ultraviolet light.