Reaction products of Resin acids and Rosin acids, sodium salts and barium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 April 2017 - 15 May 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Based on the two in vitro tests with Barium salts of resin acids and rosin acids, no conclusion could be drawn on the eye irritating potential of the substance. In order to clarify classification it was decided to perform an in vivo study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2012

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EC No 440/2008, part B: "Acute Toxicity: Eye Irritation/Corrosion"

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines

Version / remarks:

2000, including the most recent revisions

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

dd. 03 November 2015

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of Resin acids and Rosin acids, sodium salts and barium chloride

Molecular formula:

not applicable

IUPAC Name:

Reaction products of Resin acids and Rosin acids, sodium salts and barium chloride

Test material form:

solid: particulate/powder

Details on test material:

Name as cited in the report: Barium salts of resin acids and rosin acids
Appearance: light tan powder
Storage conditions: at room temperature desiccated

Specific details on test material used for the study:

pH (1% in water, indicative range): 6.8 – 7.6 (determined by Charles River Den Bosch)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River France, L’Arbresle, France
- Age at study initiation: Approximately 14-15 weeks old
- Weight at study initiation: 2862 to 3435 g
- Housing: Individually in labeled cages with perforated floors with cage enrichment (shelters, wooden sticks).
- Diet: Pelleted diet for rabbits (Global Diet 2030 Teklad®, Mucedola, Milanese, Italy), once daily; hay was available during the study period.
- Water: Municipal tap-water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 (daily mean temperature during the study period)
- Humidity (%): 59-62
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 April 2017 To: 15 May 2017

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amounts applied: 36.6 – 37.5 mg (appr. 0.1 mL

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

7 days

Duration of post- treatment incubation (in vitro):

n.a.

Number of animals or in vitro replicates:

3 (in a step-wise manner)

Details on study design:

OBSERVATIONS:
Mortality: Twice daily
Clinical signs: Once daily (postdose)
Body weights: On day 1 (pre-dose) and on the day of the final observation.
Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and/or 7 days after instillation of the test item.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system depicted in the OECD guideline.

TOOL USED TO ASSESS SCORE:
Hand-slit lamp and fluorescein (after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of three rabbits.

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three rabbits.

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: Not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Results 8

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

Irritant / corrosive response data:

Irritation of the conjunctivae, which consisted of redness and chemosis a was seen in all three animals to a minor degree. Slight discharge (score 1) was seen in all three animals in the first hour after instillation only. The irritation had completely resolved within 7 days in two animals and within 72 hours in the other animal. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage.

Other effects:

No staining of (peri) ocular tissues by the test item was observed and no test item remnants were seen. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. Body weight gain was as expected.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an in vivo eye irritation test performed according to OECD/EC guidelines and GLP principles, Barium salts of resin acids and rosin acids does not have to be classified for eye irritation.

Executive summary:

An in vivo eye irritation test was performed with Barium salts of resin acids and rosin acids according to OECD/EC guidelines and GLP principles. Instillation of approximately 37.2 mg (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness, chemosis and slight discharge (only in first hour after instillation). The irritation had completely resolved within 7 days in two animals and within 72 hours in the other animal. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage. No mortality occurred, no clinical signs were noted and body weight gain was as expected. Based on these results, Barium salts of resin acids and rosin acids is not classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and EC criteria for classification and labelling requirements for dangerous items and preparations (Council Directive 67/548/EEC) (including all amendments).