Hexylamine

Endpoint summary

Description of key information

Skin:
The test substance was corrosive to the rabbits' skin.
Eyes:
The test subsatnce was highly corrosive to the rabbits' eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific standards, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only two animals tested

Principles of method if other than guideline:

The skin irritation test was conducted according to a BASF-internal standard protocol. Two White Vienna rabbits were treated with the substance for 1 min, 5 min, 15 min, and 20 h, respectively, under occlusive conditions.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.74 and 2.92 kg

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: approx. 1 mL

Duration of treatment / exposure:

1 min, 5 min, 15 min, 20 hrs

Observation period:

8 d

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch, no further data


REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %); no (exposure 20 hrs)
- Time after start of exposure: 1, 5, and 15 min, respectively


SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

(exposure time: 1 min, 5 min, 15 min)

Time point:

other: 24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

(exposure time: 1 min, 5 min, 15 min)

Time point:

other: 24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings

Irritation parameter:

other: necrosis

Basis:

animal #1

Remarks:

(exposure time: 20 h)

Time point:

other: 24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings

Irritation parameter:

other: necrosis

Basis:

animal #2

Remarks:

(exposure time: 20 h)

Time point:

other: 24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings

Irritant / corrosive response data:

In both animals after exposure time intervals of 1 min, 5 min, 15 min, respectively, red-brown soft necrosis, i.e. superficial necrosis was noted immediately after removal of the test patches. At the following readings starting 24 hours after exposure, dark, hard necrosis, i.e. full thickness necrosis was observed at the application area. In addition, at the margins of the exposed area slight erythema (Draize score: 2) was observed in one animal after 1 min, 5 min, and 15 min exposure, respectively. At the last reading 8 days after exposure, full thickness necrosis was still present in both animals, irrespective of the exposure time.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable Guideline and GLP study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hour(s)

Observation period (in vivo):

no data

Number of animals or in vitro replicates:

9

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: a severe necrotic effect was observed

Irritant / corrosive response data:

After an exposition time of respectively 4 and 30 seconds: only one animal showed irritation of the cornea, conjunctivae redness and conjunctivae swelling. After an exposition time of 24 hrs: all tested animals showed irritation of the cornea and of the iris, conjunctivae redness and conjunctivae swelling and a severe necrotic effect was observed.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin:

The substance was tested for skin irritation / skin corrosion in a study conducted similar to OECD guideline 404. Two rabbits were exposed to the substance under occlusive conditions for exposure times of 1 min, 5 min, 15 min, and 20 h, respectively. Immediately after removal of the test patches after 1 min, 5 min, and 15 min superficial necrosis was documented. At the 24 h-reading full thickness necrosis was observed in both animals on all treated skin sites, irrespective of the exposure time. Full thickness necrosis persisted until study termination after 8 days. Based on the described test results, the substance is considered to be severely corrosive to rabbit skin.

Eyes:

In a publication an eye irritation test is described which was conducted similar to OECD Guideline 405 (Koch et al. 1985). 0.1 mL of the test substance were applied to the eyes of 9 rabbits. After an exposition time of respectively 4 and 30 seconds, only one animal showed irritation of the cornea, conjunctivae redness and conjunctivae swelling. After an exposition time of 24 hrs, all tested animals showed irritation of the cornea and of the iris, conjunctivae redness and conjunctivae swelling. A severe necrotic effect was observed. Therefore, the substance was concluded to be highly corrosive to the eyes.

In another eye irritation study (non GLP and non-guideline) 0.05 mL of the undiluted test substance (analytical purity > 99%) was applied into one eye of each of two adult New Zealand White rabbits; the treated eyes were not rinsed after application and reading of eye effects was performed 10 min, 1, 24, 48 and 72 hours after test item application. Descriptive scores of the raw data were converted into OECD Draize scores. 10 min after application of the test item, signs of chemical burns were observed at conjunctivae and bulbus. Margin of eyelids were chemically burned after 1 hour and at the observation time point 24 hours crusts were noted, which became purulent at the time point of 48 hours. Additionally, staphyloma developed and 72 hours after treatment strong suppuration was described. The eye irritation study is acceptable (reliability 2). Due to development of necrosis and staphyloma, the test item is considered corrosive to the eyes.

Justification for selection of skin irritation / corrosion endpoint:
only study available

Justification for selection of eye irritation endpoint:
The report meets generally accepted scientific standards and is considered as acceptable for assessment.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly corrosive

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for skin and eye corrosion and labeled as corrosive, R35 (Causes severe burns) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified into skin irritation/corrosion category 1A (H314: Causes severe skin burns and eye damage) and into eye irritation/corrosion category 1 (H318: Causes serious eye damage) under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC 605/2014.