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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: comparable to OECD-guideline 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
609-333-1
EC Number:
609-333-1
Cas Number:
37143-54-7
Molecular formula:
C4 H11 N O
IUPAC Name:
609-333-1
Details on test material:
- Name of test material (as cited in study report): 1-methoxy-2-aminopropan

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler: D-6050 Offenbach/Main, FRG
- Weight at study initiation: 2.77 kg
- Housing: single; cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): KLIBA 341, 4 mm; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland; about 130 g per animal per day
- Water (e.g. ad libitum): tap water; about 250 ml per animal per day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: fur was clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 ml of undiluted test substance
Duration of treatment / exposure:
3 min and 1 h
Observation period:
24, 48 and 72 h
Number of animals:
1 male rabbit per exposure period
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of untreated skin; upper third of the back or flanks
- Type of wrap if used: four layers of absorbent gauze + porous bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol and lutrol/water (1:1)
- Time after start of exposure: 3 min and 1 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: animal #1 (3 min exposure)
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 4 - 4 - 4
Irritation parameter:
erythema score
Basis:
other: animal #2 (1 h exposure)
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 4 - 4 - 4
Irritation parameter:
edema score
Basis:
other: animal #1 (3 min exposure)
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
edema score
Basis:
other: animal #2 (1 h exposure)
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritant / corrosive response data:
In both animals, the skin findings were irreversible within 72 h after the removal of the patches.
Other effects:
Both animals showed necrosis after 24 and 48 hours. After 72 h, both animals showed full thickness necrosis, which was confirmed by gross-pathology examination.

Applicant's summary and conclusion

Interpretation of results:
highly corrosive
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the substance has to be classified "highly corrosive" according to EU (R35) or GHS (Cat 1B) criteria.