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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to OECD Guideline 405 and EU Method B.5 with no deviations that affected the results of the study.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Identity (according to study report): Rosin
-Source: Hexion Specialty Chemicals, BVBA
-Date received at Testing Laboratory: 15 October 2009
-Appearance: yellowish solid
-Storage: -20 °C
-Production date: June 2009
-Expiration date: June 2010
-Purity: 100%
-Code No.: PH-09/0286
-The test sample was used as supplied, after being reduced to a fine powder.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS:
-Source: Elevage de Gerome (Quartier Labaste F40206 Linxe)
-Animals: 3 females
-Acclimation period: at least 5 days
-Weight during study : 2.52-2.92 kg
-Age at study initiation: 12 weeks
-Housing: 1/cage in air conditioned rooms
-Diet: SDS-C15, available ad libitum
-Water: drinking water (tap-water from public distribution system) available ad libitum

ENVIRONMENTAL CONDITIONS:
-Room temperature (ºC): 17-23
-Relative humidity (%): 30-70
-Air exchanges: 15 changes/hour
-Light: 12 hour light/dark cycle

IN-LIFE DATES:
-Study start: 9 November 2009
-Study end: 17 November 2009

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 gram/eye
Duration of treatment / exposure:
single application
Observation period (in vivo):
3-21 days
Number of animals or in vitro replicates:
3
Details on study design:
STUDY DESIGN:
On the day of dosing, 0.1 gram of the test substance was instilled into the conjunctival sac of one eye of each rabbit. Initially, a single animal was dosed. After consideration of the ocular responses produced in the treated eye of this rabbit on Day 1, two additional animals were added to the study and administered the test substance in the same manner. The untreated eye of each rabbit served as a control. One hour after dosing, the treated eye of each animal was rinsed with physiological saline. All treated eyes were examined and the grade of ocular reaction for each animal was recorded at 1, 24, 48, and 72 hours post-treatment. If ocular reactions were present at 72 hours, additional observations were carried out up to a maximum of 21 days. Grades of ocular reactions were determined using the Scale of Weighted Scores for Grading the Severity of Ocular Lesions (Draize, 1944).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: mean for animals 1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Reversibility does not apply since no signs of corneal irritation were evident at these observation periods.
Remarks on result:
other: The mean cornea score for each animal tested was 0.
Irritation parameter:
iris score
Basis:
animal: mean for animals 1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Reversibility does not apply since no signs of irritation to the iris were evident at these observation periods.
Remarks on result:
other: The mean iris score for each animal tested was 0.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: The mean score for conjunctival erythema for observations at 24, 48 and 72 hours was 1.3. Erythema scores were 3 at the 1-hour observation; 2 at the 24-hour observation; and 1 at the 48- and 72-hour observations. The eye was normal by Day 8.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: The mean score for conjunctival chemosis for observations at 24, 48 and 72 hours was 1.3. Chemosis scores were 3 at the 1-hour observation; 2 at the 24-hour observation; and 1 at the 48- and 72-hour observations. The eye was normal by Day 4.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The mean score for conjunctival erythema for observations at 24, 48 and 72 hours was 0.7. Erythema scores were 2 at the 1-hour observation; 1 at the 24- and 48-hour observations; and 0 at the 72-hour observation. The eye was normal by 72 hours.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The mean score for conjunctival chemosis for observations at 24, 48 and 72 hours was 0.3. Chemosis scores were 2 at the 1-hour observation; 1 at the 24-hour observation; and 0 at the 48- and 72-hour observations. The eye was normal by 48 hours.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The mean score for conjunctival erythema for observations at 24, 48 and 72 hours was 0.7. Erythema scores were 2 at the 1-hour observation; 1 at the 24- and 48-hour observations; and 0 at the 72-hour observation. The eye was normal by 72 hours.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The mean score for conjunctival chemosis for observations at 24, 48 and 72 hours was 0.3. Chemosis scores were 3 at the 1-hour observation; 1 at the 24-hour observation; and 0 at the 48- and 72-hour observations. The eye was normal by 48 hours.
Irritant / corrosive response data:
No signs of corneal irritation were evident for any treated eye at any time during the study. Iris irritation was limited to a single eye (Grade 1) at the 1-hour examination. Ocular conjunctivae reactions included redness (Grades 2-3) reversible between Days 3 and 8 and chemosis (Grades 2-3) reversible between Days 2 and 4.

Any other information on results incl. tables

The mean eye irritation scores (from the 24-, 48-, and 72-hour examinations) were calculated for each animal for classification purposes.

Mean scores (chemosis, redness, iris lesions, and corneal opacity) reported were 1.3, 1.3, 0, and 0 for Animal #1; 0.3, 0.7, 0, 0 for Animal #2; and 0.3, 0.7, 0, 0 for Animal #3, respectively.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Gum Rosin was, at most, slightly irritating when instilled into the eyes of New Zealand white rabbits. Although Gum Rosin caused initial moderate to strong conjunctival (erythema and/or chemosis) irritation based on the one-hour post-dose irritation scores, the severity of irritation quickly decreased and all signs of conjunctival irritation were completely reversible by the 72-hour (2/3 eyes) or the Day 8 (1/3) examinations. There were no adverse effects on the cornea or iris in any animals at the 24-, 48- or 72-hour examinations.

Gum Rosin is not classified for eye irritation in Annex I of Directive 67/548/EEC. Based on the calculated means from the eye irritation scores obtained at the 24-, 48-, and 72-hour observations, Gum Rosin is not classifiable for eye irritation according to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Executive summary:

In a primary eye irritation study, three female New Zealand white rabbits were administered 0.1 gram of Gum Rosin into the conjunctival sac of one eye. The remaining eye of each rabbit served as a control. All treated eyes were examined and the grade of ocular reaction for each animal was recorded at 1, 24, 48, and 72 hours post-treatment. Due to the persistence of ocular reactions, the treated eye of a single rabbit was also examined and graded on Days 4, 7, and 8. Grades of ocular reactions were determined using the Scale of Weighted Scores for Grading the Severity of Ocular Lesions (Draize, 1944). No signs of corneal irritation were evident for any treated eye at any time during the study. Iris irritation was limited to a single eye (Grade 1) at the 1-hour examination. Ocular conjunctivae reactions included redness (Grades 2-3) reversible between Days 3 and 8 and chemosis (Grades 2-3) reversible between Days 2 and 4. Discharges (Grade 2-3) were also reported early in the study. One eye was normal by Day 8 and the remaining two eyes appeared normal by 72 hours. The mean eye irritation scores (from the 24-, 48-, and 72-hour examinations) were calculated for each animal for classification purposes. Mean scores (chemosis, redness, iris lesions, and corneal opacity) reported were 1.3, 1.3, 0, and 0 for Animal #1; 0.3, 0.7, 0, 0 for Animal #2; and 0.3, 0.7, 0, 0 for Animal #3, respectively. Based on the scoring and classification system used in this study, Gum Rosin was considered to be minimally irritating to rabbit eyes and would not meet the criteria to be classified as an eye irritant.