Tall oil, maleated

Eye irritation

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: 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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rosin, fumarated

IUPAC Name:

Rosin, fumarated

Constituent 2

Reference substance name:

65997-04-8

Cas Number:

65997-04-8

IUPAC Name:

65997-04-8

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 weeksENVIRONMENTAL CONDITIONS- Temperature (°C):18-19 deg C- Humidity (%): 50-70%- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12IN-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 doneSCORING SYSTEM:Standard EU scoring systemTOOL USED TO ASSESS SCORE: hand-slit lamp (ophthalmoscope)

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

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)

Remarks:

Migrated informationCriteria 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.