3-butoxypropylamine

Endpoint summary

Description of key information

Skin irritation/corrosion:

In a K1 in vivo acute dermal irritation/corrosion study according to OECD Guideline 404 and EU Method B.4, the test item was found to be corrosive to the skin based on the criteria of the CLP regulation (EC) No 1272/2008. No reliable in vitro skin corrosion/irritation data is available.

Eye irritation:

No in vitro or in vivo eye irritation testing is required with the test substance as the substance is demonstrated to be corrosive to the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes

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

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

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

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

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.

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).

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion:

Lemoncelli (2014) investigated skin irritation/corrosion of BOPA according to the OECD Guideline 404 and EU Method B.4. After 3 minutes of exposure to 0.5 mL of the test item, severe erythema and severe edema was found through day 14. Necrosis was observed after 30-60 min post dosing through day 14, sloughing from days 11-14. Based on the results, the test item was considered to be corrosive and should be classified as Category 1A according to the criteria of the CLP regulation (EC) No 1272/2008.

 

An in vitro skin irritation study was waived based on the justification that adequate data from an in vivo skin irritation study are available.

 

Eye irritation:

An in vitro eye irritation study was waived based on the justification that the test item is classified as skin corrosion, leading to a classification as serious eye damage Category 1.

Justification for classification or non-classification

Skin Irritation/corrosion: According to the in vivo skin irritation/corrosion study, skin corrosion was observed for the test item. The test substance is therefore classified as Category 1A according to the criteria of the CLP regulation (EC) No 1272/2008.

 

Eye irritation: Based on the classification of the test item as skin corrosive (Category 1A), the test item is classified for serious eye damage Category 1 according to the CLP regulation (EC) No 1272/2008.