Fatty acids, C14-18, C14-18-alkyl esters

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): not irritating

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

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. The test substance was applied under occlusive conditions for 24 h, no experimental 48 h reading performed. Lack of detail on test material.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

exposure period 24 h, occlusive conditions, no individual scores reported at the 48 h reading time point and lack of detail on test material.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.8 - 2.4 kg

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, the untreated site of the same animal served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points: 24 and 72 h

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Type of wrap if used: occlusive patches (1" x 1" gauze, covered by adhesive tape). Following application of the test material the entire trunk of each animal was covered with an impermeable occlusive wrapping.

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values was assumed to be the same as those at 24 h

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values was assumed to be the same as those at 24 h

Irritant / corrosive response data:

No edema or erythema were seen in any of the animals tested.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. Lack of detail on test material.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

lack of detail on test material.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: not required; the untreated eye served as control" in the remarks field

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h and 4 and 7 days

Number of animals or in vitro replicates:

6 ( 3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after instillation.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-held lens

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.1

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.23

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

In 2/6 animals no irritation was observed. However, in the other animals mild to moderate conjunctival irritation and/or corneal opacity was observed but was fully reversed within 72 h. Also, in 4/6 animals’ mild iritis was observed but was reserved within 24 h. (please see table 1 for more detail).

Table 1. Results of eye irritation study.

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0	Time to reversion	0.0	0.0	0.0	0.0
2
	24	1	1	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.3	0.0	0.0	Time to reversion	48.0	48.0	0.0	0.0
3
	24	1	2	1	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.3	0.7	0.3	0.0	Time to reversion	48.0	48.0	48.0	0.0
4
	24	0	0	0	1
	48	0	0	0	1
	72	0	0	0	0
	average	0.0	0.0	0.0	0.7	Time to reversion	0.0	0.0	0.0	72.0
5
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.0	0.0	0.0	0.0	Time to reversion	0.0	0.0	0.0	0.0
6
	24	1	3	1	1
	48	1	0	0	1
	72	0	0	0	0
	average	0.7	1.0	0.3	0.7	Time to reversion	72.0	48.0	48.0	72.0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling			avg. time to reversion	28.0	24.0	16.0	24.0
average score
	24	0.50	1.00	0.33	0.33
	48	0.17	0.00	0.00	0.33
	72	0.00	0.00	0.00	0.00
	24+48+72	0.67	1.00	0.33	0.66

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

The skin irritation potential of fatty acids, C14 -18, C14 -18 -alkyl esters (CAS 85566-24-1) was investigated in a study performed equivalent to OECD TG 404 (Croda, 1976b). 0.5 g of the undiluted test substance was applied to the shaved skin of 6 rabbits, 3 of each sex and covered with an occlusive dressing for 24 h. No edema or erythema was observed in any of the animals during the 72 h observation period.  Based on these results, the test substance is not considered to be a skin irritant.

 

Eye irritation

 

The eye irritation potential of fatty acids, C14-18, C14-18-alkyl esters (CAS 85566-24-1) was investigated in a study performed equivalent to OECD TG 405 (Croda, 1976c). 0.1 mL of the undiluted test material was placed into the conjunctival sac of one eye of 6 New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were then examined and scored at 24, 48 and 72 h, 4 and 7 days after application. In 2/6 animals, no irritation was observed. However, in the remaining animals, mild to moderate conjunctival irritation and/or corneal opacity were observed but was fully reversed within 72 h. The mean conjunctivae score after 24, 48 and 72 h was 0.7 (1/6), 0.33 (2/6) and 0 (3/6). 

The mean cornea, iris, and chemosis scores after 24, 48, and 72 h were 0.23, 0.1 and 0.33 for all 6 animals, respectively. These effects were fully reversed by 72 h. Based on these results, the test substance is not considered to be an eye irritant.

 

Conclusions for irritation / corrosion

Based on the available data on skin irritation, fatty acids, C14-18, C14-18-alkyl esters (CAS 85566 -24 -1) is not considered to be skin irritating. Furthermore, the results of the eye irritation study do not indicate an eye irritation potential of fatty acids, C14-18, C14-18-alkyl esters (CAS 85566-24-1).

 

Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available.

Justification for classification or non-classification

The available data on the skin and eye irritation potential of fatty acids, C14-18, C14-18-alkyl esters (CAS 85566 -24 -1) do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

There are no data available on respiratory irritation.