Registration Dossier
Registration Dossier
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EC number: 445-790-1 | CAS number: 404362-22-7
Skin irritation / corrosion
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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- MXDA/SM
- IUPAC Name:
- MXDA/SM
- 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
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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.
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