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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:
end 1998-05-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: 1A: GLP, OECD 404 (1992 July 17th), EC 92/69 EEC B4 (1992 July 31st)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: relative humidity sometimes out of the specified range. The 1-hour and 4-hour exposures of the test substance were spaced from 7days
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-isopropoxypropylamine
EC Number:
220-816-2
EC Name:
3-isopropoxypropylamine
Cas Number:
2906-12-9
Molecular formula:
C6H15NO
IUPAC Name:
3-isopropoxypropylamine
Details on test material:
- Name of test material (as cited in study report): 3-Isopropoxypropylamine
- Physical state: liquid
- Analytical purity: 99.78%
- Purity test date: 0997-08-07
- Lot/batch No.: 9708P0073
- Expiration date of the lot/batch: December 1998
- Stability under test conditions: no data
- Storage condition of test material: in dark at room temperature
- Other: orgin: Usine de Maurienne , La Chambre

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle , 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2362mg
- Housing: alone in a polystyrene cage (35x55x32cm or 48.2x58x36.5cm)
- Diet (e.g. ad libitum): ad libitum 112C pelleted diet (U.A.R. 91360 Villemoisson sur Orge, France)
- Water (e.g. ad libitum):ad libitum drinking water filtered by FG Millipore membrane (0.22µ)
- Acclimation period:at least 5days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 12cycles
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
3min, 1h, 4h
Observation period:
1, and then daily after removal of the dressing
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 6cm²
- % coverage: -
- Type of wrap if used: gauze pad held in contact by an adhesive hypoallergenic aerated semi occlusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:


SCORING SYSTEM: according to the OECD 404guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Necrosis and thickness of the skin appeard at 24 hours and 48 hours respectively in the treated rabbit and persisted until the end of the study (14days).

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under these experimental conditions, IPOPA is corrosive when applied to rabbits.
Executive summary:

The acute dermal irritation of 3-Isopropoxypropylamine (IPOPA) was evaluated in one male New Zealand White rabbit according to OECD N° 404 Guideline. 0,5mL of IPOPA was applied during 3minutes, 1hour and 4hours in the rabbit on clipped area. The cutaneous reaction was observed one hour and then daily to day 15 after removal of the dressing.

After application of the substance during 3 minutes and 1 hour, a severe erythema (grade 4) was observed from day1 to 11. It was masked by an important necrosis of the skin thereafter. A severe oedema (grade4) was noted on day1. Necrosis and thickening of the skin were recorded from day 1or 2, up to the end of the observation period.

After a 4-hour exposure, a severe erythema was observed from days 1 to 4. It was masked by an important necrosis of the skin thereafter. Necrosis and thickening of the skin were recorded from day 1, up to the end of the observation period.

Under these experimental conditions, IPOPA has to be classified as corrosive.

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