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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to generally accepted methods (similar to OECD Guideline 405) for an eye irritation study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Identity (according to study report): UNITAC 70
-FDRL Test Article ID: 85-0693
-Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
-Source: Ace Animals, Inc., Boyertown, PA, USA
-Number of animals: 6 (4 males and 2 females)
-Age: young adults
-Acclimation period: at least 5 days
-Weight at study initiation: 2.42 - 3.11 kg
-Housing: individually in wire mesh bottom cages
-Diet: NIH 09 Rabbit Ration, supplied by Zeigler Brothers, Gardners, PA, available ad libitum
-Water: available ad libitum
-Identification: ear tags and color-coded cage cards

ENVIRONMENTAL CONDITIONS:
-Housed in environmentally-controlled rooms
-All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23.

IN-LIFE DATES:
-Study start: 1985-09-30
-Study end: 1985-10-03

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye of each animal served as the control.
Amount / concentration applied:
0.1 g into one eye of each rabbit
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
-Test material preparation:
The test material was ground with a mortar and pestle, then dispensed as an undiluted powder.

-Test material administration:
Prior to study initiation, the eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp. Only rabbits with eyes free of irritation and corneal lesions were selected for the study. On the day of dosing, 0.1 g of the test substance was instilled into one eye of each rabbit. The test substance was instilled into the eye by gently pulling the lower lid away from the eyeball to form a cup into which the material was deposited. Treated eyes were not rinsed. The remaining eye of each rabbit served as a control.

-Observations:
All eyes were examined with fluorescein and the grade of ocular reaction for each animal was recorded at 24, 48, and 72 hours post-treatment using the Draize scale for scoring ocular lesions (1944) and listed below:

The mean eye irritation score was determined for each observation period. The greatest mean score was used to assign the test substance an ocular irritation rating as described by Kay and Calandra (1962).

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

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

A X B X 5 Total Maximum = 80

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

A X 5 Total Maximum = 10

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

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

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

Score (A + B + C) X 2 Total Maximum = 20

-Data evaluation:
The mean eye irritation score was determined for each observation period. The greatest mean score was used to assign the test substance an ocular irritation rating as described by Kay and Calandra (1962) and summarized below:

Mean Score: Rating
0.0 - 0.5: Non-irritating
>0.5 - 2.5: Practically Non-irritating
>2.5 - 15.0: Minimally irritating
>15.0 - 25.0: Mildly irritating
>25.0 - 50.0: Moderately irritating
>50.0 - 80.0: Severely irritating
>80.0 - 110.0: Extremely irritating

-Body weights:
Body weights were recorded prior to administration of the test substance. Body weights were not recorded at study termination.

References:
Draize JH, Woodard G & Calvery HO. 1944. Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Ther. 377-390.

Kay JH & Calandra JC. 1986. Interpretation of Eye Irritation Tests. J. Soc. Cosmetic Chemists 13: 281-289.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0.83
Max. score:
80
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Corneal opacity (Grade 1) covering an area of one quarter or less was noted for 1/6 treated eyes; 5/6 animals were normal.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0.83
Max. score:
80
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Corneal opacity (Grade 1) covering an area of one quarter or less was noted for 1/6 treated eyes; 5/6 animals were normal.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
80
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: No corneal effects were observed.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
0.83
Max. score:
10
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Iris reaction (Grade 1) was noted for 1/6 treated eyes; this same animal had corneal effects.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0.83
Max. score:
10
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Iris reaction (Grade 1) was noted for 1/6 treated eyes; this same animal had corneal effects.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: No effects on iris were observed.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
4
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Redness (Grade 2) was noted for 1/6 treated eyes and redness (Grade 1) was noted for 5/6 treated eyes; chemosis (Grade 1) was noted for 2/6 treated eyes; discharge (Grade 1) was noted for 3/6 treated eyes.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1.33
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Redness (Grade 1) was noted for 3/6 treated eyes; chemosis was noted for 1/6 treated eyes; no discharge was observed.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: No conjunctival effects were observed.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
5.7
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The mean overall eye irritation score at 24 hours was 5.7 ± 6.1.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
3
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The mean overall eye irritation score at 48 hours was 3.0 ± 5.5.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Based on the scoring and classification systems in the study report, the test substance was considered to be minimally irritating to rabbit eyes.
Other effects:
No signs of irritation were evident for the six untreated contralateral (control) eyes of the rabbits.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Rosin, reaction products with formaldehyde (CAS No. 91081-53-7) is not considered to be an eye irritant in rabbits when tested using a method similar to OECD Guideline 405.

Rosin, reaction products with formaldehyde (CAS No. 91081-53-7) is not classified for eye irritation in Annex I of Directive 67/548/EEC. Based on the minimal signs of irritation noted during the study, the reported Draize scores, the number of affected animals for each category, and the duration of response, this material is not classifiable for eye irritation according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Executive summary:

In a primary eye irritation study, 0.1 gram of UNITAC 70 (rosin, reaction products with formaldehyde) was instilled into the conjunctival sacs of each of six young adult New Zealand white rabbits (4 males, 2 females). The remaining eye of each rabbit served as a control. All eyes were examined with fluorescein and the grade of ocular reaction for each animal was recorded at 24, 48, and 72 hours post-treatment using the Draize (1944) scale for scoring ocular lesions. Slight signs of irritation were seen for the cornea, iris, and conjunctiva. The mean eye irritation score was determined for each observation period. The overall mean eye irritation scores (± S.D.) out of a possible 110 points were 5.7 (± 6.1) at 24 hours, 3.0 (± 5.5) at 48 hours, and 0 at 72 hours. All treated eyes were normal by the 72-hour examinations. Based on the scoring and classification systems in the study report, the test substance was considered to be minimally irritating to rabbit eyes.