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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl hydrogen 2-nitroterephthalate
EC Number:
252-360-5
EC Name:
Methyl hydrogen 2-nitroterephthalate
Cas Number:
35092-89-8
Molecular formula:
C9H7NO6
IUPAC Name:
4-(methoxycarbonyl)-3-nitrobenzoic acid
Details on test material:
- Name of test material (as cited in study report): Nitro-MMT


Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach; strain Chbb:NZW(SPF)
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.4 - 2.5 kg
- Housing: in fully air conditioned rooms, separate cages (arranged in a battery)
- Diet: Altromin 2123 maintenance diet-rabbits, ad libitum; hay (approx. 15 g/day)
- Water: from automatic water dispenser, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 50 +-20
- Lighting time: 12 hours daily

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
0.5 g Nitro-MMT pasted with 0.15 ml polyethylene glycol 400
Duration of treatment / exposure:
4 hours
Observation period:
30 - 60 min, 24 h, 48 h, 72 h after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cellulose patch on a piece of surgical plaster covered with a semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
according to Draize:
erythema: 0 - 4; oedema: 0 - 4;

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 162, 163 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal: # 164
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
animal: # 162, 163, 164 each
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritant / corrosive response data:
From one hour up to 24 hours after removal of the patches the treated skin of two animals showed very slight erythema.
48 hours after removal of the patches the irritations were fully reversible.
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Nitro-MMT is not irritating and not corrosive to the skin.
Executive summary:

Nitro-MMT was tested for skin irritation according to OECD 404. Following this guideline the skin of three New Zealand albino rabbits was treated with 500 mg of the test item under semi-occlusive coverage. The exposure period was 4 hours. From one hour up to 24 hours after removal of the patches the treated skin of two animals showed very slight erythema, that were fully reversible within 48 hours. No edema were observed after removal of the patches. Based on these findings Nitro-MMT has not to be regarded as irritating or corrosive to skin.