3-(methylamino)propane-1,2-diol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

27 September 1993 and 2 November 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline No 404 and in accordance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aminopropandiol

IUPAC Name:

Aminopropandiol

Constituent 2

Reference substance name:

3-aminopropane-1,2-diol

EC Number:

210-475-8

EC Name:

3-aminopropane-1,2-diol

Cas Number:

616-30-8

IUPAC Name:

3-aminopropane-1,2-diol

Constituent 3

Reference substance name:

3-amino-1,2-propanediol

IUPAC Name:

3-amino-1,2-propanediol

Details on test material:

- Name of test material (as cited in study report): Aminopropandiol
- Physical state - yellow, viscous, transparent liquid
- Batch Number - 1201-362-93
- Storage condition of test material: Refrigerated at 5°C

Test animals

Species:

rabbit

Strain:

other: SPF albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mollegaard Breeding Centre Denmark
- Weight at study initiation: 2.5-2.8 kg
- Housing: singe PPL cages with perforated floor
- Diet (e.g. ad libitum): feed pellets "Altromin 2123" from Chr. Petersen A/S, DK-4100 Lille Skensved, ad libitum
- Water (e.g. ad libitum): drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): range of 18-24
- Humidity (%): 55 plus or minus 15
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Lot/batch no. (if required): 1201-362-93

Duration of treatment / exposure:

4 hours

Observation period:

1 hour

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 10 x 10 cms on the back.
- Type of wrap if used: gauze secured with 1cm wide adhesive tape and fixed with Scanpor tape, 4.5 cms width loosely wound round the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with soap and lukewarm water
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48 72h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible

Remarks:

14d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48 72h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 7d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 72h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14d

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24, 48 72h

Score:

1.83

Max. score:

4

Reversibility:

not fully reversible within: 14d

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48 72h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48 72h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48 72h

Score:

2.67

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24, 48 72h

Score:

0.5

Max. score:

4

Irritant / corrosive response data:

At the reading one hour after termination of treatment very slight to well-defined erythema and oedema were observed in 3 rabbits while severe erythema and moderate to severe oedema were observed in one rabbit (no. 6585). The exposed skin of the last rabbit was also covered with small wounds.
At the following 24, 48 and 72 hour readings very slight to well-defined erythema and oedema were still observed in 3 rabbits. In one rabbit (6586) severe erythema and moderate oedema were observed. A dark brown to black inelastic crust was observed covering the exposed skin site at the 24, 48 and 72 hour readings.
On day 7 the skin appeared normal in one rabbit (6585) while scattered white scales with intact skin underneath were observed in another rabbit (6584). In rabbit 6587 a small wound (about 1 x 0.5 cm) was seen on the left skin site. Scattered white scales were seen covering the test sites of this rabbir. A black inelastic crust was seen at both sites in rabbit 6586.
On day 14 scar tissue measuring 1 x 0.5 cm was observed on the teft test site of rabbit 6587 indicating irreversible skin changes in this rabbit. A black crust undergoing demarcation was seen in rabbit 6586.
On day 21 the black crust covering the test site of rabbit 6586 were still undergoing demarcation.
On day 28 scar tissue was observed under the crusts of rabbit no 6586.
It was then concluded that aminopropandiol induced irreversible skin changes in two of the rabbits and the study was terminated.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It was concluded that Aminopropandiol induces irreversible skin changes in two rabbits and the study was terminated. Aminopropandiol shall be classifed as corrosive.