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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:
July 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2012
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
May 2008, including most recent amendments.
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147.
Version / remarks:
November 2000, including the most recent partial revisions.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate d.d. 3 November 2015

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Resin acids and Rosin acids, hydrogenated, zinc salts
- Substance type: Brown coloured, brittle solid
- Storage condition of test material: At room temperature
Specific details on test material used for the study:
pH (1% in water, indicative range): 6.3 – 6.8 (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:
- Source: Charles River France, L’Arbresle, France.
- Age at study initiation: Between 12 and 13 weeks old.
- Weight at study initiation: Body weights were between 2509 and 3061 grams.
- Housing: Individually housed in cages with perforated floors and shelters.
- Diet: Pelleted diet for rabbits approximately 100 grams per day (Global Diet 2030 Harlan Teklad, Italy). Hay and wooden sticks were available during the study period.
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
set to maintain:
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12

Deviations from the maximum and daily mean relative humidity occurred (range of actual daily mean 54-85%).
Evaluation: These deviations were mostly transient and not adversely impact the outcome of the study.

IN-LIFE DATES: From: 06 July 2016 to 21 July 2016

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: average 42.6 mg (range: 42.4 mg – 42.9 mg) (a volume of approximately 0.1 mL)
Duration of treatment / exposure:
Single instillation on day 1
Observation period (in vivo):
72 hours after instillation of the test item
Number of animals or in vitro replicates:
3 males
Details on study design:
STUDY DESIGN
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 12 days later, after considering the degree of eye irritation observed in the first animal.

TREATMENT
Test item was installed in the conjunctival sac of one of the eyes.

REMOVAL OF TEST SUBSTANCE
-Washing (if done): Yes
Immediately after the 1 hour observation, the treated eye of two of the animals, were rinsed with approximately 30 mL tepid tap water, using a velocity of flow which did not affect the eye, to remove any visible residual test item. For reference control the other eye was also rinsed.

OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to instillation) and after the final observation.
- Necropsy: No necropsy was performed. After the final observation, the first animal was sacrificed. The other two animals were removed from the study alive.
- Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test item.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405.

Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal:
Remarks:
#1, 2,and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal:
Remarks:
#1, 2, and 3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
Animal #1 and 2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Remarks:
Animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Animal #1, 2 and3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no evidence of ocular corrosion.
Instillation of the test item into one eye of each of three rabbits resulted in slight irritation of the conjunctivae, which consisted of redness (1 animal, score 1), chemosis (2 animals, score 1) and/or discharge (2 animals, score 1) at 1 hour after instillation only. Two animals showed slight irritation of the conjunctivae, which consisted of redness (score 1) at 1 hour and 24 hours after installation. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other two animals.
No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage.
Other effects:
Remnants of the test item were present in the eye of two animals on day 1.
No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study with rabbits, performed according to OECD 405/EC test guidelines, limited irritation was observed.
Executive summary:

An acute eye irritation study in the rabbit was performed with Resin acids and Rosin acids, hydrogenated, zinc salts according to OECD 405/EC guidelines and in accordance with GLP principles. Single samples of approximately 42.6 mg of Resin acids and Rosin acids, hydrogenated, zinc salts (a volume of approximately 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Slight irritation of the conjunctivae, which consisted of redness (all animals, score 1), chemosis (2/3 animals, score 1) and/or discharge (2/3 animals, score 1) were observed after installation. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other two animals. Remnants of the test item were present in the eye of two animals on day 1.

Based on these results, Resin acids and Rosin acids, hydrogenated, zinc salts do not have to be classified and have 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).