Resin acids and Rosin acids, cobalt salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-04-11 to 2006-05-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Minor deviations with no effects on the study: - According to the guideline, for the initial test in one animal, the test site is also examined immediately after the patch has been removed. In this study report there was no statement indicating if this was done. - 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 animal weights at the start and at the conclusion of the test should be stated. In this study report only a mean body weight with standard deviation was stated, which only indicated the mean body weight at the beginning of the study. - According to the guideline, in the test report the volume of vehicle used should be stated. This was missing in this study report.

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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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 2.8 +/- 0.1 kg
- Housing: The animals were housed individually in Pajon cages (50 cm X 57 cm X 75 cm). Each cage was equipped with a food container and a water bottle.
- Diet: During the study, the animals 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: corn oil

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test item
VEHICLE:
Due to the properties of the test item (degradation on contact with water), corn oil, batch No. 015K0115 (Sigma, Saint-Quentin-Falavier, France was used in order to moisten a gauze pad and ensure a good contact with the skin.
No further information on amount/concentration applied was stated.

Duration of treatment / exposure:

One animal : 3 minutes, 1 hour and 4 hours
Other animals: 4 hours

Observation period:

Observation period was approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. Since there were persistent irritation reactions at 72 hours, the observation period was extended (15 days).

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
The day before treatment, both flanks of each animal were clipped using electric clippers. Clipping was repeated thereafter on days 12 and 13 for one animal and on days 2 and 5 for one animal. Doses of 500 mg of the test item in its original form were placed on a gauze pad moistened with corn oil, which was then applied to an area of approximately 6 cm^2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals. For the 4 hour exposure, a gauze pad moistened with corn oil was applied to the opposite flank, which acted as control. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wiped off by means of a dry cotton pad ofr of a moistened cotton pad with corn oil.

SCORING SYSTEM:
Draize scoring system
No further information on details on study design was stated.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal # 1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 15 days

Remarks on result:

other: On day 15 very slight erythema was still seen.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days.

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal # 2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal # 3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal # 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

After a 3 minute exposure (one animal):
A very slight or well-defined erythema (grade 1 or 2) was noted from day 2 until day 8. A slight brown colouration of the skin, associated with a dryness of the skin on day 7, was observed from day 1 until day 9.
After 1 hour exposure (one animal):
A very slight or well-defined erythema (grade 1 or 2) was noted from day 1 until day 15 (end of the observation period).
A slight brwon colouration of the skin was observed from day 1 until day 15 (end of the observation period). A dryness of the skin was recorded from day 6 until day 15 (end of the observation period).
After a 4 -hour exposure (three animals):
On the psoterior right flank (test item application)
A very slight or well-defined erythema (grade 1 or 2) was noted in all the animals from day 1 until day 7 (one animal), 12 (one animal) or 15 (end of the observation period) (one animal). A brown colouration of the skin was observed in all the animals from day 1 until day 4 (one animal), 7 (one animal) or 15 (end of the observation period) (one animal).
A dryness of the skin was recorded in all the animals between day 5 and day 15 (end of the observation preiod). A residual of test item was recorded in 2/3 animals from day 1 until day 4 (one animal() or 15 (end of the observation period) (one animal).
On the posterior left flank (corn oil application)
A very slight erythema (grade 1) was noted in 1/3 animals from day 1 until day 5.

Any other information on results incl. tables

Only the raw data up to 72 hours are stated:

Raw data for 3 -minute exposure:

Rabbit No.	Dermal irritation	1 hour	24 hours	48 hours	72 hours	Mean irritation score (24 h, 48 h, 72h)
1	Erythema	0	2	2	2	2.0
	Oedema	0	0	0	0	0.0

Raw data for 1 hour-exposure:

Rabbit No.	Dermal irritation	1 hour	24 hours	48 hours	72 hours	Mean irritation score (24 h, 48 h, 72h)
1	Erythema	2	2	2	2	2.0
	Oedema	0	0	0	0	0.0

Raw data for 4 hour-exposure:

Rabbit No.	Dermal irritation	1 hour Day 1	24 hours Day 2	48 hours Day 3	72 hours Day 4	Mean irritation score (24 h, 48 h, 72h)
1	Erythema	2	2	2	2	2.0
	Oedema	0	0	0	0	0.0
2	Erythema	2	2	2	2	2.0
	Oedema	0	0	0	0	0.0
3	Erythema	2	2	2	2	2.0
	Oedema	0	0	0	0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the test item Produit Y was irritant when applied topically to rabbits.
According to (EC) No.: 1272/2008, and subsequent regulations, the test item is not classified as skin irritant.