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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
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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2012
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EC No 440/2008, part B: "Acute Toxicity: Eye Irritation/Corrosion"
Deviations:
no
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

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

Resultsopen allclose all
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
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
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
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
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
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
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
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).