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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Nov - 25 Nov 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No full product composition given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): STABIRAM MS6
- Physical state: yellow liquid
- Analytical purity: 47.11%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components (by weight):
- Ash : 4.07 %
- Active material: 47.11%
- water: 28.09%
- Colour gardner: 2.2
- Alkalnity ml HCl (N)/g: 0.02
- Acid value mg KOH/g: 0.48
- Purity test date: 22 Sep 2000
- Lot/batch No.: 91622125; Elf Atochem filing number: CAL 3847/99
- Stability under test conditions: Not indicated, considered stable.
- Storage condition of test material: Glass flask, at room temperature and protected from light
- Other: from test article description Elf Atochem:
- liquid at 20°C
- freezing point: -13°C
- specific gravity: 998 kg/m3 at 25°C
- Flash point > 100°C
- Expiration date of the lot/batch: Oct 2000

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Breeder: Elevage Cunicole de Val de Selle, 80160 Prouzel, France.
Number of animals: One male New Zealand White rabbit was used.
Acclimation: at least 5 days before the beginning of the study.
Weight: on the day of treatment, the animal had a body weight 2.5 kg.
Identification: individual metal ear tag.
Environmental conditions: under continuous control and recording.
. temperature: 18±3°C
. relative humidity: 30 to 70%
. lightldark cycle: 12 h/12 h
. ventilation: approximately 12 cycles/hour of filtered, non-recycled air.
The animal was housed individually in polystyrene cage (48.2 cm x 58 cm x 36.5 cm).
The cage was equipped with a food container and a water bottle.
During the study, the animal had free access to 112 C pelleted diet (UAR, 91360 Villemoissonsur-Orge, France).
Each batch of food is analysed by the supplier for composition and contaminant levels. (appendix to report)
Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
Bacteriological and chemical analyses of water are performed regularly by external laboratories.

DEVIATION FORM PROTOCOL:
. the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the protocol.
This minor deviation was not considered to compromise the validity or integrity of the study.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped using electric clippers
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml placed on a dry gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animal. The pad was held in place by adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
Duration of treatment / exposure:
3 minutes and 4 hours
After removal of the dressing, any residual test substance was wiped off by means of a moistened gauze pad.
Observation period:
1 hour, 24, 48 and 72 hours after removal of the dressing.
When there was persistent cutaneous irritation after 72 hours, the observation period was extended to a maximum of 14 days (until day 15) in order to determine the progress of the lesions and their reversibility.
Number of animals:
1
Details on study design:
The untreated skin served as control.
Any change in the animal's behaviour was noted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 minute exposure
Time point:
other: 24, 48, and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
Score 4 on day 8 when killed for ethical reason.
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 minute exposure
Time point:
other: 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Score 4 on day 8 when killed for ethical reason.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
4 hr exposure
Time point:
other: 24, 48, and 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
Score 4 on day 8 when killed for ethical reason.
Irritation parameter:
edema score
Basis:
mean
Remarks:
4 hr exposure
Time point:
other: 24, 48, and 72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks:
Score 4 on day 8 when killed for ethical reason.
Irritant / corrosive response data:
After a 3-minute or 4-hour exposure, a moderate to severe erythema (grade 3 or 4) and a slight to severe oedema (grade 2 or 4) were observed between day 2 and day 8; crusts were recorded from day 3 or day 5 and cutaneous necrosis was noted on day 8. The animal was then killed on day 8 for ethical reason.
Mean scores over 24, 48 and 72 hours for the animal after a 4-hour exposure were 3.0 for erythema and 2.0 for oedema.
Other effects:
no data.

Any other information on results incl. tables

Scoring dermal irritation:

      1h 24h 48h 72h Mean        
  rabbit day 1 2 3 4 24/48/72 5 6 7 8
3 min #1 Erythema 2 3 3 3 3,0 4 4 4 4
  Oedema 0 2 2 2 2,0 2 2 2 4
    Other                  
4-hrs #1 Erythema 2 3 3 3 3,0 4 4 4 4
  Oedema 2 2 2 2 2,0 2 2 2 4
    Other     A A   A A A N

A = Crust

N = Necrosis

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Signs of necrosis became apparent after 8 days observation following 3 minutes exposure.
Therefore, the test substance STABIRAM MS6 is corrosive when applied topically to rabbits. GHS Cat. 1B.
Executive summary:

Stabiram MS6 was tested under GLP according to OECD 404.

0.5 ml was dermally applied to the clipped skin of one rabbits under semi-occusive conditions for 3 minutes and 4 hours. Following both exposure durations the mean score for erythema and edema at 24, 48 and 72 hours after patch removal were 3.0 for erythema and 2.0 for edema. Also following both exposures necrosis was noted on day 8.

Therefore Stabiram MS6 should be classified according to GHS as: Corrosive (Category 1B).