Octylamine

Endpoint summary

Description of key information

Causes severe burns. Risk of serious damage to 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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Cited as Directive 84/449/EEC, B.4

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 2.1 - 2.2 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20*/- 3°C
- Humidity (%): 50 +/-20%
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

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

Duration of treatment / exposure:

3 minute(s)

Observation period:

1, 24, 48. and 72 hours, 7, 14, and 21 days post treatment

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: gauze, held inpalce by cotton wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 3 minutes


SCORING SYSTEM: table contained in OECD TG 404

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.44

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: scoring was only possible adjacent to the treated site, due to coloring and severe corrosion of the treated skin

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: scoring was only possible adjacent to the treated site, due to coloring and severe corrosion of the treated skin

Irritant / corrosive response data:

After 3 min, the skin showed severe burns, with green-brown staining within 30 - 60 min.
After 1 h, the treated area hardened, was swollen and turned dark red to black. The injured skin area was sharply demarcated from the healthy skin with erythema and edema at the transition line.
At 14 and 21 days post treatment, the skin was dry, rough and crusty. New skin had formed which was parchment-like and scarred.

Interpretation of results:

Category 1A (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After a 3 minute contact period, N-octylamine caused irreversible skin corrosion in all three treated rabbits.

Executive summary:

The skin irritating properties of n-octylamine were examined in a GLP OECD TG 404 study using 3 rabbits. 0.5 mL of the neat test substance were applied to the shaved intact dorsal skin and washed off after 3 minutes. The skin reactions were recorded at 1, 24, 48, and 72 hours after treatment, and thereafter at 7, 14, and 21 days.

The skin reactions adjacent to the treated sites were evaluated according to the table contained in OECD TG 404, because the skin at the treated sites was colored and did not allow evaluation at all readings up to 72 hours. After 1 h, the treated area hardened, was swollen and turned dark red to black. The injured skin area was sharply demarcated from the healthy skin with erythema and edema at the transition line. At 14 and 21 days post treatment, the skin was dry, rough and crusty. New skin had formed which was parchment-like and scarred. Overall, n-octylamine was highly corrosive to the rabbit’s skin as it caused irreversible skin corrosion after a 3-minute contact period (Hoechst, 1984).

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

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

other: none

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 h, not rinsed

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

4

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no



SCORING SYSTEM: table of Draize

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

3.75

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Remarks on result:

other: not evaluated in all animals

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Remarks on result:

not determinable

Remarks:

All animals were killed at 24 hours for humane reasons.

Irritant / corrosive response data:

Severe conjunctival and corneal damage and necrosis in all animals

1-Octylamine was corrosive to the eye. All four animals exhibited severe conjunctival and corneal damage and necrosis. 

All animals were killed at 24 h for  humane reasons.

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

N-octylamine is highly corrosive to the rabbit's eye

Executive summary:

The eye irritating properties of n-octylamine were examined in a non-GLP study that was conducted and evaluated in accordance with OECD TG 405. Four rabbits received 0.1 mL of the undiluted test substance into the conjunctival sac of one eye without rinsing. Severe conjunctival (mean score 3 for redness and 3.75 for chemosis) and corneal damage (mean score 4) and necrosis was seen in all four animals at 24 hours after treatment, and all animals were killed at 24 hours for humane reasons (Biodynamics, 1985).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin:

The skin irritating properties of n-octylamine were examined in several valid studies with short periods of skin contact of 1 or 3 minutes with similar results. In the Key Study, a GLP OECD TG 404 study using 3 rabbits, 0.5 mL of the neat test substance were applied to the shaved intact dorsal skin and washed off after 3 minutes. The skin reactions were recorded at 1, 24, 48, and 72 hours after treatment, and thereafter at 7, 14, and 21 days.

The skin reactions adjacent to the treated sites were evaluated according to the table contained in OECD TG 404, because the skin at the treated sites was colored and did not allow evaluation at all readings up to 72 hours. After 1 h, the treated area hardened, was swollen and turned dark red to black. The injured skin area was sharply demarcated from the healthy skin with erythema and edema at the transition line. At 14 and 21 days post treatment, the skin was dry, rough and crusty. New skin had formed which was parchment-like and scarred. Overall, n-octylamine was highly corrosive to the rabbit’s skin as it caused irreversible skin corrosion after a 3-minute contact period (Hoechst, 1984).

Eye:

The eye irritating properties of n-octylamine were examined in a non-GLP study that was conducted and evaluated in accordance with OECD TG 405. Four rabbits received 0.1 mL of the undiluted test substance into the conjunctival sac of one eye without rinsing. Severe conjunctival (mean score 19.5) and corneal damage (mean score 80) and necrosis was seen in all four animals at 24 hours after treatment, and all animals were killed at 24 hours for humane reasons (Biodynamics, 1985).

Respiratory irritation:

N-Octylamine was an upper respiratory tract irritant. It depressed the breathing frequency rapidly within a minute in a concentration-related manner:  
RD₅₀ = 17 ppm (91 mg/m³) [with 1 ppm = 5.37 mg/m³]. An initial decrease of about 20% was observed already at 6 and 8 ppm (43 mg/m³). In any case, the normal respiration rate restored completely within 30 min after cessation of exposure (Gagnaire, 1993; cf. chapter 7.9.3).

Justification for selection of skin irritation / corrosion endpoint:
guideline study according to GLP

Justification for selection of eye irritation endpoint:
comparable to guideline

Effects on skin irritation/corrosion: highly corrosive

Effects on eye irritation: highly corrosive

Effects on respiratory irritation: irritating

Justification for classification or non-classification

According to the criteria set in Regulation (EC) No 1272/2008 a classification for skin corrosion Category 1A and eye damage Category 1 is required as available data indicate that the substance causes skin corrosion already after 3 min of exposure and severe damage to the eyes.