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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: Study to OECD Guideline and subject to GLP audit

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): rosin, fumarated
- Substance type: Chemically modified UVCB
- Physical state: solid
- Analytical purity:assumed 100% (Certificate of analysis provided)
- Purity test date: 26.3.91
- Lot/batch No.:260391
- Stability under test conditions: assumed stable
- Storage condition of test material: ambient temp in amber glass jar

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex
- Age at study initiation: 4.5 mo
- Weight at study initiation: 3.51 kg
- Housing: suspended stainless steel cage
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum):ad lib
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-19 deg C
- Humidity (%): 50-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 3/06/1991-3/06/1991

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
Instilled and eye held closed for 1 second
Observation period (in vivo):
5 h
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done


SCORING SYSTEM:
Standard EU scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp (ophthalmoscope)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
other: Discharge
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 5 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 5 h
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 5 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 5 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
other: 5 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Animal sacrificed at 5 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Animal sacrificed after 5 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Animal sacrificed after 5 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Animal sacrificed after 5 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: Animal sacrificed after 5 hours
Irritant / corrosive response data:
Classifiable 'severe eye irritant' (DSD) or Category 1 eye irritant (GHS).

Any other information on results incl. tables

In view of the result the substance was not administered to further animals.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Rosin, fumarated is considered to be an eye irritant in rabbits when tested using a method similar to OECD Guideline 405.

Rosin, fumarated 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 this study the potential for rosin, fumarated (0.1 g) to cause eye irritation was evaluated after instillation into the eyes of one New Zealand White rabbit. The animal was observed and then terminated 5 hours after application. After 5 hours, the substance was found to be a severe eye irritant, and further testing was therefore not warranted.