Resin acids and Rosin acids, cobalt salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-04-27 to 2006-05-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Minor deviations without an effect on the study: -According to the guideline, after recording the observations at 24 hours, the eyes may be further examined with the aid of fluorescein. In the study evaluation with the aid of fluorescein was performed at 24 hours and no after the recording of the observations at 24 hours. - According to the guideline a rationale for in vivo testing should be stated in the study report. This is missing in this study report. - According to the guideline, the individual body weight at start and conclusion of the the test should be stated. In this study, the individual body weight of the animals at the start and at the conclusion of the study were not stated. - In the Draize scoring system referes conjunctival redness to palpebral and bulbar conjunctivae and excludes cornea and iris. In this study cornea and iris are included in the scoring system.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002-04-24

Deviations:

yes

Remarks:

Minor deviations with no effect on the study (see rationale for reliability)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Resin acids and Rosin acids, cobalt salts

EC Number:

273-321-9

EC Name:

Resin acids and Rosin acids, cobalt salts

Cas Number:

68956-82-1

IUPAC Name:

λ²-cobalt(2+) bis((1R,4aR,4bR,10aR)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,4b,5,6,10,10a-decahydrophenanthrene-1-carboxylate)

Details on test material:

- Name of test material (as cited in study report): Produit Y
- Name of test material (as cited in the EC inventory): Resin acids and Rosin acids, cobalt salts
- Physical state: Purple powder
- Storage condition of test material: At room temperature, protected from light and humidity and under argon gas
- The pH of the test item was not measurable (test item not soluble in water).

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Grimaud frères selection S.A.S., La Corbière, Roussay, France
- Age at study initiation: On the day of treatment, the animals were 2 to 4 months old
- Weight at study initiation: On the day of treatment, the animals had a mean body weight +/- standard deviation of 3.0 +/- 0.1 kg.
- Housing: The animals were housed individually in Pajon cages (50 cm X 57 cm X 75 cm) equipped with a food container and a water bottle.
- Diet: During the study, the animal had free access to 110C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Relative humidity: 30 to 70 %
- Ventilation: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item in its original form
No further information on amount/concentration applied was stated.

Duration of treatment / exposure:

not stated

Observation period (in vivo):

The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test item.

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
The eyes were not rinsed after administration of the test item.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Conjucntival reactions, iritis and corneal opacification were evaluated daily for each animal. For evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution (a clear fluorscence is visible in the area of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.
No further information in details on study design was stated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal # 2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal # 2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Slight or moderate chemosis (grade 1 or 2), slight or moderate redness of the conjunctiva n(grade 1 or 2) and clear discharge were observed in all the animals on day 1; some of these reactions persisted until day 2 (one animal) or 3 (two animals).
A slight corneal opacity (grade 1 ) was recorded in 2/3 animals on day 2.
No other ocular reactions were noted during the study.

Any other information on results incl. tables

Raw data of individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)

Rabbit No.	Region of eye	Eye irritation	1 hour Day 1	24 hours Day 2	48 hours Day 3	72 hours Day 4	Mean irritation score (24, 48 and 72 hours)
1	Conjunctivae	Chemosis	2	1	1	0	0.7
		Redness	2	1	1	0	0.7
		Discharge	1	0	0	0	0.0
	Iris		0	0	0	0	0.0
	Corneal opacity	Intensity	0	1	0	0	0.3
		Area	0	1	0	0	0.3
	Other		Residual test item
	Fluorescein		Fluorescein not used	Fluorescein used	Fluorescein used	Fluorescein used
2	Conjunctivae	Chemosis	2	1	0	0	0.3
		Redness	2	1	1	0	0.7
		Discharge	1	0	0	0	0.0
	Iris		0	0	0	0	0.0
	Corneal opacity	Intensity	0	0	0	0	0.0
		Area	0	0	0	0	0.0
	Other		Residual test item
	Fluorescein		Fluorescein not used	Fluorescein used	Fluorescein not used	Fluorescein not used
3	Conjunctivae	Chemosis	1	1	0	0	0.3
		Redness	2	1	0	0	0.3
		Discharge	1	0	0	0	0.0
	Iris		0	0	0	0	0.0
	Corneal opacity	Intensity	0	1	0	0	0.3
		Area	0	1	0	0	0.3
	Other		Residual test item
	Fluorescein		Fluorescein not used	Fluorescein used	Fluorescein used	Fluorescein not used

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the test item Produit Y was slightly irritant when administered by ocualr route to rabbits.
Also, the test item should not be classified as skin irritant according to Regulation (EC) No.: 1272/2008.