3-butoxypropylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 16 March 2014 to 31 March 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-butoxypropylamine

EC Number:

240-566-8

EC Name:

3-butoxypropylamine

Cas Number:

16499-88-0

Molecular formula:

C7H17NO

IUPAC Name:

3-butoxypropylamine

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 8291-11-20
- Expiration date of the lot/batch: 2014-12-31
- Purity: 99.46 wt%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, 22 to 26°C
- Stability under test conditions: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was dosed as received

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: 1 male New Zealand White rabbit; Milbrook
- Age at start of dosing: approximately 12 weeks
- Weight at study initiation: 3.0 kilograms (Day 1)
- Housing: individually housed in compliance with USDA Guidelines. No other species were kept in the same room.
- Diet (e.g. ad libitum): PMI Certified Hi-Fiber Rabbit Diet #5325 as per Calvert SOP.
- Water (e.g. ad libitum): ad libitum, via an automatic watering device.
- Acclimation period: a minimum of 5 days prior to dosing. During the acclimation period, each rabbit was observed at least once daily for any abnormalities or for the development of infectious disease. Only animals that were determined to be suitable for use were assigned to the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22°C
- Humidity (%): 38 to 62%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2014-03-17 To: 201-03-31

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

3 minutes

Observation period:

14 days

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure: The test article was applied to one intact site (~5 cm x 5 cm) on the dorsal trunk of the animal
- % coverage: no data
- Type of wrap if used: the test article was applied on the intact site on the dorsal trunk of the animals and covered with a gauze patch for a 3 minute exposure. The patch was lossely held in contact with the skin (semi-occlusive) by wrapping the trunk of the animal with an elastic bandage dressing which was held in place with non-irritating tape for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period, residual test article was removed using water and gauze, without altering the existing response or integrity of the epidermis.
- Time after start of exposure: 3 minutes

OBSERVATION TIME POINTS
- Mortality/morbidity: once daily
- Clinical observations: prior to dose administration and then daily
- Dermal observations: erythema and edema immediately after patch removal and at 30-60 minutes, and daily through Day 14
- Body weight: prior to dose administration and after the final skin grading

SCORING SYSTEM:
- According to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

necrosis after 30-60 min post-dose

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

necrosis after 30-60 min post-dose

Irritant / corrosive response data:

- 3 min exposure: severe erythema and severe edema through Day 14. Necrosis through Day 14, sloughing from Days 11-14.
- Since the observations after 3 minutes exposure indicated that a 60 minute exposure was not necessary and could not be humanely conducted, the second patch was not applied. The 4 hour site was also not dosed.

Other effects:

Mortality/Clinical observations:
- No mortality was observed during the study. No clinical signs were recorded during the course of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

The test substance Surfonamine MW 781 was found to fall into Category 1A according to GHS (Corrosive responses in at least one animal following exposure ≤ 3 min during an observation period ≤ 1 h).