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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A GLP study equivalent to OECD guideline method and results reliable for hazard assessment.
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
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A GLP study equivalent to OECD guideline method and results reliable for hazard assessment.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose:
read-across source
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
21.5
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: SD= 6.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
13.2
Max. score:
110
Remarks on result:
other: SD=3.9
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
4.3
Max. score:
110
Remarks on result:
other: SD=3.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #5
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #6
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Remarks on result:
other: score at 7 days was 1.0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
no other data
Other effects:
no data

none

Interpretation of results:
other: Irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Resin acids and rosin acids, fumarated, esters with glycerol is considered to be an eye irritant in rabbits when tested using a method similar to OECD Guideline 405.

Resin acids and rosin acids, fumarated, esters with glycerol is 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 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:

This data is being read across from the source study that tested Resin acids and Rosin acids, fumarated, esters with glycerol based on category read across that is explained in the category justification document attached in Section 13 of the dossier.

In a primary eye irritation study, 0.1 gram of UNI-REZ 757 (resin acids and rosin acids, fumarated, esters with glycerol) was instilled into the conjunctival sacs of each of six young adult New Zealand white rabbits. The remaining eye of each rabbit served as a control.  Ocular reaction for each animal was recorded at 24, 48, and 72 hours post-treatment and scored. 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 21.5 (± 6.3) at 24 hours, 13.2 (± 3.9) at 48 hours, and 4.3 (± 3.3) at 72 hours. All treated eyes were normal by the 7-day examinations. Based on the scoring and classification systems in the study report, the test substance was considered to be irritating to rabbit eyes.

Substance tested is a rosin adduct ester. On structural and synthetic grounds it is probable that the substance is similar to the test substance. Thus, on animal welfare grounds a further test should not be undertaken.

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:
yes
Remarks:
No wash out at 1 h. Grading scores applied were Draize.
Principles of method if other than guideline:
n/a
GLP compliance:
yes
Remarks:
FDA (21 CFR Part 58)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 84-0981; UNI-REZ 757
- Molecular formula (if other than submission substance):
- Substance type: Reaction product derived from UVCB
-

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LaCrosse Industries, Inc., Schenectady, New York
- Age at study initiation: young
- Weight at study initiation: 2.32-3.09kg
- Housing: Individually housed in wire mesh bottom cages
- Diet (e.g. ad libitum): Ad libitum, NIH 09 Rabbit Ration (Zeigler Brothers, Gardners, PA)
- Water (e.g. ad libitum):Ad libitum
- Acclimation period: at least 5 days

Test system

Vehicle:
not specified
Controls:
other: Second eye as untreated control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1g
Duration of treatment / exposure:
up to 7 days
Observation period (in vivo):
24, 48, and 72hrs post-treatment and at 7 days
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
21.5
Max. score:
110
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: SD= 6.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
13.2
Max. score:
110
Remarks on result:
other: SD=3.9
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
4.3
Max. score:
110
Remarks on result:
other: SD=3.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
110
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #5
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #6
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Remarks on result:
other: score at 7 days was 1.0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24 h
Score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
48 h
Score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
no other data
Other effects:
no data

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
other: Irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Resin acids and rosin acids, fumarated, esters with glycerol is considered to be an eye irritant in rabbits when tested using a method similar to OECD Guideline 405.

Resin acids and rosin acids, fumarated, esters with glycerol is 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 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 UNI-REZ 757 (resin acids and rosin acids, fumarated, esters with glycerol) was instilled into the conjunctival sacs of each of six young adult New Zealand white rabbits. The remaining eye of each rabbit served as a control.  Ocular reaction for each animal was recorded at 24, 48, and 72 hours post-treatment and scored. 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 21.5 (± 6.3) at 24 hours, 13.2 (± 3.9) at 48 hours, and 4.3 (± 3.3) at 72 hours. All treated eyes were normal by the 7-day examinations. Based on the scoring and classification systems in the study report, the test substance was considered to be irritating to rabbit eyes.

Substance tested is a rosin adduct ester. On structural and synthetic grounds it is probable that the substance is similar to the test substance. Thus, on animal welfare grounds a further test should not be undertaken.