Reaction mass of Dicerium trisulfide and Dilanthanum trisulfide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From 30 May 1994 to 03 October 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dicerium trisulphide

EC Number:

234-603-7

EC Name:

Dicerium trisulphide

Cas Number:

12014-93-6

Molecular formula:

Ce2S3

IUPAC Name:

Dicerium trisulphide

Test material form:

solid: particulate/powder

Remarks:

migrated information:

Details on test material:

- Name of test material (as cited in study report): Cerium sulphide

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.05 kg
- Housing: animals were housed individually in polystyrene cages (35 x 55 x 32 cm or 48.2 x 58 x 36.5 cm). Each cage was equiped wity a food container and a water bottle.
The housing conditions (temperature, relative humidity and light/dark cycle) were checked monthly.
- Diet: free access to 112 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France). Each batch of food was analysed (composition and contaminants) by the supplier.
- Water: ad libitum, drinking water filtered by a F.G. Millipore membrane (0.22µm) and contained in bottles.
Bacteriological and chemical analysis of water and detection of possible contaminants (pesticides, heavy metals and nitrosamines) are performed periodically.
There were no contaminants in the diet or water at levels likely to have influenced the outcome of the study.
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30-70 %
The temperature and relative humidity were recorded continuously and records retained.
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: 15/06/1994 to 23/06/1994

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: parrafin oil

Controls:

other: the untreated left flank skin served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance in its original form.

VEHICLE
- Amount(s) applied (volume or weight with unit): the test substance was moistened with 0.5 ml of paraffin oil.
- Lot/batch no. (if required): 5830
- Purity: no data

Duration of treatment / exposure:

4 hours

Observation period:

- 1, 24, 48 and 72 hours after removal of the dressing.
- When there is persistent cutaneous irritation after 72 hours, the observation period is extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and their reversibility or irreversibility.
- Any change in the animals' behaviour was noted.

Number of animals:

3 males

Details on study design:

TEST SITE
- The day before treatment, the flanks of each animal were clipped using clippers. Only animals showing no obvious signs if irritancy were used for the study.
- Area of exposure: 6 cm2
- % coverage: No data
- Type of wrap: Adhesive hypoallergenic aerated semi-occlusive dressing (Laboratoires de Pansements et d'Hygiène, 21300 Chenove, France) and a restraining bandage (Laboratoires 3M Santé, 92245 Malakoff, France).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressings were removed and any residual test substance was wiped off with a gauze patch moistened with paraffin oil.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Scale of 0 to 4 for both erythema and edema (according to OECD Guideline 404).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48 and 72 h

Score:

0

Remarks on result:

other: Red coloration of the skin at the 24 hour time point, which could obscure an eventual erythema at grade 1

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: Red coloration of the skin at the 24 hour time point, which could obscure an eventual erythema at grade 1

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 h

Score:

2

Remarks on result:

other: Red coloration of the skin at the 24 and 48 hour time points, which could obscure an eventual erythema at grades 1 to 2

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48 and 72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48 and 72 h

Score:

0

Results 7

Irritation parameter:

other:

Basis:

animal #3

Time point:

other: 72 hours

Remarks on result:

other: Dryness of the skin

Irritant / corrosive response data:

- No edema was observed during the study.
- A red colouration of the treatment site by residual subtsance had prevented the evaluation of a slight or a well-defined erythema during 24 hours for 2 animals and during 48 hours for the last animal.
From day 3, no cutaneous reactions were observed for 2 animals.
For the last animal, a well-defined, then a very slight erythema and/or a dryness of the skin were observed from day 4 to day 8.
On day 9, no cutaneous reactions persisted.

Other effects:

No other effects.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

As the mean scores for erythema, edema for 2 out of the 3 animals did not reach the criteria values for irritation. Under the experimental conditions of the study, the test substance Dicerium trisulphide, was considered as non-irritant when administered by cutaneous route in rabbits.

Executive summary:

The potential of the test substance Dicerium trisulphide to induce dermal irritation was evaluated in rabbits according to O.E.C.D (No. 404, 17th July 1992) and E.C. (92/69/E.E.C.) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.

 

Method

A single dose of 0.5 g of the test substance in its original form was prepared on a moistened compress,and then applied to a 6 cm2 clipped area of the skin of 3 male New Zealand White rabbits. The test substance was held in contact with the skin for 4 hours by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1, 24, 48 and 72 hours after removal of the dressing and then daily until day 9 at the latest in order to observe their reversibility. Any residual test substance was removed by means of a compress moistened with paraffin oil.

The mean score of the values for erythema and edema recorded for each animal after 24, 48 and 72 hours was calculated.

The interpretation of results was carried out according to the classification criteria laid down in Directive 93/21/E.E.C. Commission Directive of 27th April 1993 adapting to technical progress for the eighteenth time Council Directive 67/548/E.E.C.

 

Results

No edema was observed during the study.

In all 3 animals, a red coloration of the treatment site by residual test substance had prevented the evaluation of a very slight or a well-defined erythema during 24 or 48 hours.

From day 3, no cutaneous reactions were observed for 2 animals. For the last animal, a well-defined, then, a very slight erythema and/or a dryness of the skin were observed from day 4 to day 8.

On day 9, no cutaneous reactions persisted.

 

Conclusion

The mean scores for erythema, edema for 2 out of the 3 animals did not reach the criteria values for irritation. Under the experimental conditions of the study, the test substance Dicerium trisulphide, was considered as non-irritant when administered by cutaneous route in rabbits.