Fatty acids, C14-18 and C16-18-unsatd., ammonium salts

Endpoint summary

Description of key information

Skin: Based on read across studies for skin irritation on chemically similar substances, Fatty acids, C14-18 and C16-18-unsatd., ammonium salts are considered to be not skin irritating.

Eye: Based on read across studies for eye irritation on chemically similar substances, Fatty acids, C14-18 and C16-18-unsatd., ammonium salts are considered to be slightly eye irritating.

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:

1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP study, equivalent or similar to OECD Guideline.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Type of coverage:

occlusive

Preparation of test site:

other: both test sites clipped, one abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

48 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 1.5x1.5 inch
- Type of wrap if used: plastic trunk bands

REMOVAL OF TEST SUBSTANCE
- Washing: all test sites were washed with solvent
- Time after start of exposure: 4 hours after application, after the first reading

SCORING SYSTEM:
The primary irritation index is calculated by adding the values for erythema or eschar fonnation, and ederna at 4 I 24 and 48 hours on intact and abraded skin (12 values) and dividing by six to obtain an individual score on each rabbit.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h / 48 h

Score:

0.04

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h / 48 h

Score:

0

Max. score:

4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 h / 48 h

Score:

0.04

Max. score:

8

Reversibility:

fully reversible within: 48 h

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-29 to 1988-02-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: Official Journal, European Community, 27, L 251, 1984, p. 106-108.

GLP compliance:

yes

Species:

rabbit

Strain:

other: Klienrusse, Chbb

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberrach/D.
- Age at study initiation: n/a.
- Weight at study initiation: 2452.5g (average of 4 animals).
- Housing: single husbandry in rabitt cages.
- Diet: breeding/husbandry diet 20 ZH 5.
- Water: tap water ad libitum.
- Acclimation period: min. 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature: ca. 20 - 21 °C.
- Humidity: ca. 45 - 50 %.
- Air changes (per hr): n/a.
- Photoperiod (hrs dark / hrs light): 12 hours.

Type of coverage:

occlusive

Preparation of test site:

shaved

Remarks:

24 hours before application.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

The test substance Edenor C16 was proved in undiluted form on primary skin irritation. 0.5g of the product was evenly applied on a 2.5cm x 2.5cm linen rag.

Duration of treatment / exposure:

4 hours.

Observation period:

3 days.

Number of animals:

4.

Details on study design:

The linen rag was put on the shaved back skin of the rabbit and wrapped in a plasic foil which was fixed with adhesive plasters and an acrylastic band for occlusive coverage.

Irritation parameter:

erythema score

Basis:

animal: #1,2,3,4

Time point:

other: 4 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritation parameter:

edema score

Basis:

animal: #1,2,3,4

Time point:

other: 4 hours

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritation parameter:

erythema score

Basis:

animal: #1,2,3,4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritation parameter:

edema score

Basis:

animal: #1,2,3,4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

No skin reactions were observed.

Other effects:

no data.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not considered to be classified as skin irritant (no irritant to skin).

Executive summary:

The substance Edenor C16 was tested for its primary skin irritation under occlusive conditions on the back skin of 4 rabbits (Method: Off. J.  Europ. Commun. 27, L 251, 1984, p. 106 -108 and Guideline for Testing of Chemicals. Section 4, No. 404, OECD).

After a contact time of 4 hours the skin reactions were evaluated.

No skin reactions were observed.

According to the criteria in Off. J. Europ. Commun. 26 (L 257) 1983, the substance Edenor C16 doesn't need to be classified regarding its irritation potential.

Reference 3

Endpoint:

skin irritation / corrosion, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read-across (analogue): For justification of read-across see section 13.2.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4h

Score:

0

Max. score:

4

Remarks on result:

other: No effects.

Remarks:

Result of the analogue substances Palmitic acid.

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4h

Score:

0

Max. score:

4

Remarks on result:

other: No effects.

Remarks:

Result of the analogue substances Palmitic acid.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48 h

Score:

0.04

Max. score:

4

Reversibility:

fully reversible within: 48h.

Remarks on result:

other: Result of the analogue substances Oleic acid.

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Remarks on result:

other: Result of the analogue substances Oleic acid.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48 h

Score:

0.04

Max. score:

4

Reversibility:

fully reversible within: 48h.

Remarks on result:

other: Result of the analogue substances Oleic acid.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on GHS criteria the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for skin corrosion/irritation.
Based upon the DSD classification criteria (67/548/EEC) the target substance is not considered to be classified for Corrosive or Irritating to skin.

Executive summary:

Two studies are available in which the skin irritation according (or simular) to OECD Guideline 404 on rabbits of the analogue substances (Palmitic acid, Oleic acid) were determined. As results, no skin irritation was observed.

Based on read across studies for skin irritation on chemically similar substances, Fatty acids, C14-18 and C16-18-unsatd., ammonium salts is considered to be no skin irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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: Well documented publication, acceptable for assessment with restriction.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not applicable

Principles of method if other than guideline:

Several substances were tested in 12 different laboratories to compare their assessments.

GLP compliance:

not specified

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-2.5 kg

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

Eyelids were held together for 1 second, substance was not washed out

Observation period (in vivo):

observations were recorded at 24, 48, 72 hours and 7 days after application

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM:
according to Draize

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 h

Score:

>= 0 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

>= 0.42 - <= 2.1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 h

Score:

>= 0 - <= 1.62

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

After 24 hours 5 out of 12 collaborating laboratories found signs of irritancy in the rabbits’ eyes caused by the analogue substance and 5 laboratories assessed borderline findings. Two collaborators did not find signs indicating eye irritation. After 48 hours signs indicating irritation were evaluated by one out of 12 collaborators and 2 collaborators recorded borderline findings. 9 collaborators evaluated the substance as non-irritating. After 72 hours, the total number of animals showing any signs of eye irritation had decreased and still 9 collaborators evaluated the substance as non-irritant, 3 as borderline substance. On day 7 all tested animals were assessed symptom free. After 24 hours the mean scores for each six rabbits were between 0 and 2.0 (range 0) for corneal opacity, 0 - 0.65 for iritis, 0.42 - 2.1 for conjunctival redness and 0 - 1.62 for chemosis. Mean scores after 48 and 72 hours are not given in the publication.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-03-04 to 1988-03-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: Official Journal, European Community, 27, L 251, 1984, p. 109-112.

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrusse Chbb

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Fa. Thomae, Biberach/D.
- Age at study initiation: male adults.
- Weight at study initiation: 2297.5g (average of 4 animals).
- Housing: single husbandry in rabitt cages.
- Diet: Altromin diet 2023.
- Water: tap water ad libitum.
- Acclimation period: min. 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature: ca. 20 - 21 °C.
- Humidity: ca. 45 - 50 %.
- Air changes (per hr): n/a.
- Photoperiod (hrs dark / hrs light): 12/12 hours.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1g of the test material got slightly warmed up and got applied to the sac of the conjunctiva of the right eye. The eyelids were held together shortly. The test material was kept in contact with the mucous membranes of the eye constantly.

Duration of treatment / exposure:

3 days.

Observation period (in vivo):

The test animals were obseved 1, 6, 24, 48 and 72 hours after exposure.

Number of animals or in vitro replicates:

4.

Details on study design:

24 hours before applying the eye of the rabbits were checked for their health. The untreated eyes of the rabbits were studied using a 0.5% aqueous sodium fluorescein solution to verify whether the cornea was intact.
0.1ml of a 0.5% aqueous sodium fluorescein solution were administered in the conjunctival sac. 20 seconds later the treated eye was rinsed with lukewarm tap water intensively. After that the cornea got examined for discoloration. If there is no coloration on the cornea the epithel is intact and is considered as undamaged.
This examination was repeated 24 hours after the administration of the test substance, after the membranes had already been examined macroscopically on inflammatory symptoms and evaluated on the basis of the Draize test.

Irritation parameter:

cornea opacity score

Basis:

animal: #1,2,3,4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects

Irritation parameter:

iris score

Basis:

animal: #1,2,3,4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: no effects

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: #1,2,3,4

Time point:

other: 6h

Score:

1.25

Max. score:

3

Reversibility:

fully reversible within: 24h

Irritation parameter:

chemosis score

Basis:

animal: #1,2,3,4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h

Irritation parameter:

other: exudation

Basis:

animal: #1,2,3,4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24h

Irritant / corrosive response data:

Reactions of the conrea as well as the iris were not observed.The conjunctival reactions were slight and disappeared totally within 24 hours. The fluorescein mehtod confirmed that no corneal reactions appeared.

Conjunctival reactions after the application of the undiluted test subustance Edenor Ti Dest. and permanent contact:

                                    hour after treatment

annimals no.	1 A B C	6 A B C	24 A B C	48 A B C	72 A B C
858	1 1 2	1 0 0	0 0 0	0 0 0	0 0 0
859	1 0 0	1 0 0	0 0 0	0 0 0	0 0 0
860	1 1 1	1 0 0	0 0 0	0 0 0	0 0 0
861	1 0 2	2 0 0	0 0 0	0 0 0	0 0 0
mean	1.00 0.50 1.25	1.25 0 0	0 0 0	0 0 0	0 0 0

A = Redness; B = Chemosis; C = Exudation.

Interpretation of results:

GHS criteria not met

Conclusions:

Due to the slightly conjunctival reactions and the fast reversibility of the observed eyes the substance Edenor Ti Dest. does not require a hazard warning label relating to its mucous membranes irritating properties.

Executive summary:

The substance Edenor Ti Dest. was tested for primary eye irritation on rabbits by a single application of 0.1g of the undiluted test product an permanent contact (Method: Off. J. Europ. Commun. 27, L 251, 1984, p. 109 -112 and Guidelines for Testing of Chemicals. Section 4, No 405, OECD).

Reactions on the cornea and iris were not observed.

The conjunctival reactions were slight and disappeared totally within 24 hours after application.

According to the criterea in Off. J. Europ. Commun. 26 (L 257), 1983 the test substance doesn't need to be classified regarding its eye irritation potential.

Reference 3

Endpoint:

eye irritation, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Read-across (analogue): For justification of read-across see section 13.2.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Reason / purpose for cross-reference:

read-across: supporting information

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: No effects.

Remarks:

Result of the analogue substances Fatty acids, C16-18 and C18-unsatd..

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: No effects.

Remarks:

Result of the analogue substances Fatty acids, C16-18 and C18-unsatd.

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 6h

Score:

1.25

Max. score:

3

Reversibility:

fully reversible within: 24h.

Remarks on result:

other: Result of the analogue substances Fatty acids, C16-18 and C18-unsatd.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h.

Remarks on result:

other: Result of the analogue substances Fatty acids, C16-18 and C18-unsatd.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

>= 0 - <= 2

Max. score:

4

Reversibility:

fully reversible within: 7d.

Remarks on result:

other: Result of the analogue substances potassium oleate.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

>= 0.42 - <= 2.1

Max. score:

3

Reversibility:

not fully reversible within: 7d.

Remarks on result:

other: Result of the analogue substances potassium oleate

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

>= 0 - <= 1.62

Max. score:

4

Reversibility:

fully reversible within: 7d.

Remarks on result:

other: Result of the analogue substances potassium oleate

Two studies/publication are available in which the eye irritation according (or simular) to OECD Guideline 405 on rabbits of the analogue substances (Fatty acids, C16-18 and C18-unsatd., potassium oleate) were determined.

As results for Fatty acids, C16-18 and C18-unsatd., slightly irritation to eye was observed (Reactions of the conrea as well as the iris were not observed.The conjunctival reactions were slight and disappeared totally within 24 hours.).

As results for potassium oleate, slightly irritation to eye was observed (After 24 hours the mean scores for each six rabbits were between 0 and 2.0 (range 0) for corneal opacity, 0 - 0.65 for iritis, 0.42 - 2.1 for conjunctival redness and 0 - 1.62 for chemosis.).

Based on the structural similarity of the target substance to the analogue substances the results of eye irritation of the source substances can be assigned to the target substance.

The supporting information of the eye irritatron of the analogue substances are also available: Ammonium stearate (slightly eye irritation), Sodium stearate  (slightly eye irritation), Oleic Acid (no eye irritation and slightly eye irritation), Myristic Acid (slightly eye irritation), Palmitic Acid (no eye irritation) and Stearic acid (no eye irritation). This support information circumstantiates the result of the read-across projection to eye irritation of the target substance.

Therefore Fatty acids, C14 -18 and C16 -18 -unsatd., ammonium salts is considered to be slightly eye irritating.  

Interpretation of results:

GHS criteria not met

Conclusions:

Based on GHS criteria the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for serious eye damage / eye irritation.
Based upon the DSD classification criteria (67/548/EEC) the target substance is not considered to be classified for serious damage to eyes / irritating to eyes.

Executive summary:

Based on read across studies for eye irritation on chemically similar substances, Fatty acids, C14-18 and C16-18-unsatd., ammonium salts is considered to be slightly eye irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No adequate animal data are available and no epidemiological studies investigating the skin or eye irritation potential of the test (target) substance were identified. However, data from a structural analogue (read across substance) are available.

Skin irritation: Two studies are available in which the skin irritation according (or simular) to OECD Guideline 404 on rabbits of the analogue substances (Palmitic acid, Oleic acid) were determined. As results, no skin irritation were observed. Based on the structural similarity of the target substance to the analogue substances the results of the Skin irritation of the source substances can be assigned to the target substance. The supporting information of the Skin Iriitation of the analogue substances are also available: Ammonium stearate (PDII: 0.62, slight skin irritation), Sodium stearate  (PDII: 0, no skin irritation), Oleic Acid (PDII: 0.5, minimal erythema), Myristic Acid (PDII: 0, no skin irritation), Palmitic Acid (PDII: 0, no skin irritation) and Stearic acid (PDII: 0, no skin irritation and PDII: 0.33, slight skin irritation)). This information supports the result of the read-across projection to Skin irritation of the target substance.

Eye irritation: Two studies/publication are available in which the eye irritation according (or simular) to OECD Guideline 405 on rabbits of the analogue substances (Fatty acids, C16-18 and C18-unsatd., potassium oleate) were determined. As results for Fatty acids, C16-18 and C18-unsatd., slightly irritation to eye were observed (Reactions of the conrea as well as the iris were not observed. The conjunctival reactions were slight and disappeared totally within 24 hours.). As results for potassium oleate, slightly irritation to eye was observed (After 24 hours the mean scores for each six rabbits were between 0 and 2.0 (range 0) for corneal opacity, 0 - 0.65 for iritis, 0.42 - 2.1 for conjunctival redness and 0 - 1.62 for chemosis.). Based on the structural similarity of the target substance to the analogue substances, the results of eye irritation of the source substances can be assigned to the target substance. The supporting information of the eye irritation of the analogue substances are also available: Ammonium stearate (slightly eye irritation), Sodium stearate (slightly eye irritation), Oleic Acid (no eye irritation and slightly eye irritation), Myristic Acid (slightly eye irritation), Palmitic Acid (no eye irritation) and Stearic acid (no eye irritation). This support information circumstantiates the result of the read-across projection to eye irritation of the target substance.

Justification for classification or non-classification

Skin:

Based on GHS criteria the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for skin corrosion/irritation.

Based upon the DSD classification criteria (67/548/EEC) the target substance is not considered to be classified for Corrosive or Irritating to skin.

Eye:

Based on GHS criteria the target substance "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts" is not considered to be classified for serious eye damage / eye irritation.

Based upon the DSD classification criteria (67/548/EEC) the target substance is not considered to be classified for serious damage to eyes / irritating to eyes.