3-methoxypropylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Well documented study performed according to a method similar to OECD TG 404. No 14 days follow-up is performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no follow-up during 14 days after exposure

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxypropylamine

EC Number:

226-241-3

EC Name:

3-methoxypropylamine

Cas Number:

5332-73-0

Molecular formula:

C4H11NO

IUPAC Name:

3-methoxypropan-1-amine

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 3-methoxipropylamin, 85/455

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
- Age at study initiation: no data
- Weight at study initiation: 2.87 kg (males); 3.16 kg (females)
- Housing: 1 animal per cage, cage made of stainless stell with wire mesh walk floors (area 40 x 51 cm), no bedding in the cages; saw-dust in the waste trays
- Diet (e.g. ad libitum): Kliba 341.4 mm (Switzerland) - ad libitum
- Water (e.g. ad libitum): about 250 ml tab water per animal per day - ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): fully air-conditioned rooms: 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h (06:00-18:00 light)

Test system

Type of coverage:

other: test patch is secured with a porous dressing (4 layers of absorbent gauze - porous bandage)

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 ml of the undiluted test substance is absorbed by the patch (2.5 x 2.5 cm)

Duration of treatment / exposure:

3 min, 1 hour

Observation period:

72 h

Number of animals:

1 male, 2 females per exposure duration

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol / water (1:1)
- Time after start of exposure: after 3 min, resp 1 h exposure
- Readings: 30 - 60 minutes after removal of the test patches and 24h, 48h, 72h after the beginning of the application

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 3 min, 24h, 48h, 72h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: 3 min exposure

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 3 min, 24h, 48h, 72h

Score:

0.6

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: 3 min exposure

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1h, 24h, 48h, 72h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: 1h exposure

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1h, 24h, 48h, 72h

Score:

1.2

Max. score:

4

Reversibility:

not fully reversible within: 72h

Remarks on result:

other: 1h exposure

Irritant / corrosive response data:

Necrosis is observed in all animals exposed for 3 min. At 72h after exposure, full thickness necrosis is confirmed by gross pathology examination.
The mean scores for edema after 3 min exposure are resp 1.0; 0.3; 0.3.

Necrosis is observed in all animals exposed for 1 hour. At 1 and 72h edema was extended beyond the area of exposure in one animal. At 24 and 48h edema was extended in two animals. At 72h after exposure, full thickness necrosis is confirmed by gross pathology examination.
The mean scores for edema after 1h exposure are resp 2.0; 0.7; 1.0

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

In an in vivo acute dermal irritation test performed similar to OECD 404, rabbits are exposed to the test substance during resp 3 min and 1h. On the basis of the observations and the lack of reversibility of effects, the substance is considered to be Corrosive Cat 1A according to the CLP Regulation No 1272/2008.