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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:
2004-03-12 To: 2004-06-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guidline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Gauze square were not protected by a pad and not held in place by elastic, adhesive hypoalergenic tape. Deviation does not affect study outcome
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report):MXDA/SM adduct
- Lot/batch No.: PSM-02A
- Physical state: yellow liquid
-Storage condition of test material: stored under nitrogen at ambient temperature, protected from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: GEVAC (Les Hautes Noes, Saint Mars d'Egrenne, 61350 Passais la conception, France)
- Weight at study initiation: 3.5 kg
- Housing: individually, in standard size cage
- Diet: SDS/DIETEXnSTANRAB (P) SQC ad libitum
- Water: ad libitum
- Acclimation period: 5 days prior to testing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21°C
- Humidity (%): 45-65%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12712

IN-LIFE DATES: From: 2004-03-23 To: 2004-03-26

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
Duration of treatment / exposure:
3 minutes exposure
1 h exposure
4 h exposure
Observation period:
1h (where appropriate), 24, 48 and 72 hours post exposure
Number of animals:
1 female rabbit
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 per patch
- % coverage: no data
- Type of wrap if used: gauze, semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: up to 4h

SCORING SYSTEM:
Erythema and eschar formation
No erythema: 0
Very slight erythema (Barely discernable): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beat redness) to scab formation hindering classification based on erythema: 4

Oedema formation
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4h exposure
Time point:
other: 1h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 4 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritant / corrosive response data:
Mean index(Mi)

3 min exposure: mean erythema 3.33 / mean oedema 4.0
1 h exposure: mean erythema 3.33 / mean oedema 4.0
24 h exposure: mean erythema 3.67 / mean oedema 3.67
Other effects:
At time point 24 h and 48 h after removal of patches green and brown colouration of each site appeared. These zones were surrounded with an erythemateous zone.
At time point 72h the additinally skin suppleness decreased and necrosis was noted.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is corrosive to the skin. Necrosis, destruction of the skin appeared later than 48h observation.
CPL Classification Category 1B is proposed
Executive summary:

Primary dermal irritation study was performed with MXDA/SM Adduct in accordance with OECD guideline No. 404 (1981).

The test substancewas applied to three different sites topically dermal (approximately 6 cm2) on the back of the one New Zealand White rabbit for 3 minutes (one patch), 1 hour (second patch) and 4 hours (third patch) of exposure. After completion of the exposure period the treated areas were observed after 1h, 24 h, 48 h and 72 h post exposure.

Moderate to severe erythema (Score 3 -4) and odema (Score 3-4) were noted at all three application sites after 24 until 72 h post exposure. At time point 24 h and 48 h after removal of patches green and brown colouration of each site appeared. These zones were surrounded with an erythemateous zone. At time point 72h the additinally skin suppleness decreased and necrosis was noted.

Based on the result above, the test material was decided to be a corrosive material.