C12-18-(even numbered, C18 unsaturated)-alkylamines acetates

Endpoint summary

Description of key information

C12 -18 -(even numbered, C18 unsaturated)-alkylamines acetates revealed skin corrosive properties when tested in animals according to OECD 404. No studies are available with regard to eye irritation. However, based on the corrosive properties a severe eye irritation potential has to be assumed.

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: Guideline study according to GLP

Qualifier:

according 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, Kastengrund, conventional breeding
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: fully air-conditioned rooms, seperate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat - Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum

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

IN-LIFE DATES: from 1984-11-20 to: 1984-12-11

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (moistened with 0.4 mL physiological saline)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 mL isotonic saline

Duration of treatment / exposure:

4 hrs; 60 minutes; 3 minutes (3 animals each)
Then test substance was removed from the skin with warm tap water

Observation period:

30 - 60 min. after removal of the patches
24, 48 and 72 hrs after removal of the patches
7, 14, 21 days after removal of the patches

Number of animals:

9

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The moistened substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skin area (ca. 25 cm2) and then covered with a semi-occlusive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure:
animals #1-3: 3 min.
animals #4-6: 1 hr
animals #7-9: 4hrs


SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Irritation parameter:

erythema score

Basis:

other: mean all animals

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

edema score

Basis:

other: mean all animals

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

other: application time 3 min

Irritation parameter:

erythema score

Basis:

other: mean all animals

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

edema score

Basis:

other: mean all animals

Time point:

other: 24h / 48h / 72h

Score:

0.9

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24h / 48h / 72h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24h / 48h / 72h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24h / 48h / 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: application time 1 hr

Irritation parameter:

erythema score

Basis:

other: mean all animals

Time point:

other: 24h / 48h / 72h

Score:

1.2

Max. score:

2

Remarks on result:

other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24h / 48h / 72h

Score:

1

Max. score:

1

Remarks on result:

other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24h / 48h / 72h

Score:

1

Max. score:

2

Remarks on result:

other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24h / 48h / 72h

Score:

1.7

Max. score:

2

Remarks on result:

other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed

Irritant / corrosive response data:

Following 3 minute exposure no skin reactions were observed. Following 60 minute exposure skin reactions indicative of an irritative response were observed which were fully reversible 14 days p.a.. Following 4 hours exposure scare formation was observed in all 3 animals 21 days p.a.

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Testing of the substance for primary dermal irritation in the rabbit showed that, based on the criteria laid down in the Directive 83/467/EEC, the substance has to be labelled as corrosive (C) with the designation R34 - causes burns.

Executive summary:

C12 -18 -(even numbered, C18 unsaturated)-alkylamines acetates was tested for skin irritation / corrosion according to OECD test guideline 404 in rabbits. Each animal was treated with 500 mg Cocoalkylamine acetate moistened with 0.4 mL isotonic saline and covered by semi-occlusive bandage. The exposure period was 3 min, 1 hour and 4 hours. After the exposure period all remnants were carefully removed from the skin with warm tap water. Readings were performed 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because effects were still present after 72 hours, additional readings were performed after 7 days 14 and 21 days.

Following a three minute exposure peride, the test material is considered to be not irritating to skin.

After a contact time of 1 hour C12 -18 -(even numbered)-alkylamines acetates was irritating. There were clear localized erythema and slight edema. The surface of the skin was dry, brittle, with fine and coarse scales, parchment-like, chapped and light brown. After 21 days the skin had healed without scarring.

After a contact time of 4 hours, the treated skin became hardened, arched and green-brown to brown. From 14 days after removal of the patches, for the treated skin desquamation of coarse / fine scales causing scar and eschar formation was observed. The application sites were sharply defined against the surrounding skin . Due to the strong hardening of the skin erythema and edema formation could only be assessed at the surrounding skin of the application site, but not at the application site itself.

Based on these results, technically pure Cocoalkylamine acetate must be considered as corrosive to skin following a 4 hour exposure period.

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 need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes

Reason / purpose for cross-reference:

data waiving: supporting information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

C12 -18 -(even numbered, C18 unsaturated)-alkylamines acetates was tested for skin irritation / corrosion according to OECD test guideline 404 in rabbits. The exposure period was 3 min, 1 hour and 4 hours and readings were performed 30 - 60 minutes as well as 24, 48 and 72 hours as well as 7, 14 and 21 days after removal of the patches. Following a three minute exposure periode, the test material is considered to be not irritating to skin. After a contact time of 1 hour C12 -18 -(even numbered)-alkylamines acetates was irritating. There were clear localized erythema and slight edema. The surface of the skin was dry, brittle, with fine and coarse scales, parchment-like, chapped and light brown. After 21 days the skin had healed without scarring. After a contact time of 4 hours, the treated skin became hardened, arched and green-brown to brown. From 14 days after removal of the patches, for the treated skin desquamation of coarse / fine scales causing scar and eschar formation was observed. The application sites were sharply defined against the surrounding skin . Due to the strong hardening of the skin erythema and edema formation could only be assessed at the surrounding skin of the application site, but not at the application site itself.

Based on these results, technically pure C12 -18 -(even numbered, C18 unsaturated)-alkylamines acetates must be considered as corrosive to skin following a 4 hour exposure period.

Based on the skin corrosive properties, no eye irritation study has been performed but severe eye irritation effects have to be assumed.

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

Justification for selection of eye irritation endpoint:
No study for eye irritation is available for the registration substance. However, based on the skin corrosive properties of the registration substance a severe eye irritation potential has to be assumed.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on close structural and functional similarities, C12 -18 -(even numbered, C18 -unsaturated)-alkylamines acetates is considered to be corrosive to skin (category 1B). Based hereupon, no testing for eye irritation was performed.