Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated

Endpoint summary

Description of key information

Skin irritation: not irritating (EU Method B.4, GLP)
Eye irritation: not irritating (OECD 405/EU Method B.5, GLP)

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:

3 - 17 Nov 1987

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)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: The Broek Institute, Somere, The Netherlands
- Age at study initiation: ca. 13 weeks
- Weight at study initiation: 2393 - 2565 g
- Housing: Animals were individually housed in plastic cages with perforated floors.
- Diet: standard laboratory animal diet (100 g/day, LK-01, diameter 4 mm), obtained from Hope Farms, Worden, The Netherlands
- Water: tap-water, ad libitum via automatic nozzles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 55 - 75
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

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

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 days
Reading time points: 40 min, 24, 48 and 72 h, 7 and 14 days

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: The test substance was applied to a 6 cm² gauze patch which was attached with a drop of petrolatum to aluminium foil and mounted on permeable tape (Micropore, 3M, St. Paul, USA). This was applied to the dorsal left flank of each animal, the right flank being covered with the same dressing without substance.
- Type of wrap if used: Animals were wrapped in flexible bandage (Coban, 3M, St. Paul, USA).

REMOVAL OF TEST SUBSTANCE
- Washing: After exposure, the remaining test substance was removed, using dry tissue and subsequently a tissue moistened with tap-water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: mean after 24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: mean after 24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The test results are shown in Table 1. Forty minutes after test substance removal, the exposed skin showed well-defined erythema and slight swelling in two animals and very slight erythema and edema in the third animal. The erythema varied between very slight and well-defined during the following days and had disappeared on Day 14 in all three animals. The edema persisted until the 72 h observation time in all three rabbits.

Other effects:

No signs of systemic intoxication were observed in any of the rabbits.

Table 1. Results of the skin irritation study.

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
40 min	1	1	2	2	2	2
24 h	1	1	1	1	1	1
48 h	1	1	2	1	2	1
72 h	1	1	2	1	1	1
7 days	0	0	1	0	1	0
14 days	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	1.00	1.00	1.67	1.00	1.33	1.00

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:

06 - 16 Aug 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom, UK

Species:

rabbit

Strain:

other: Hsdlf:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.15 and 3.28 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: 2930C Teklad Global Rabbit diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

2 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

EXAMINATIONS

CLINICAL SIGNS: clinical signs of toxicity, if present, were also recorded.

BODY WEIGHT: Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study.
Minimal conjunctival irritation was noted in both treated eyes 1 and 24 h after treatment and in one treated eye at the 48 h observation. Minimal chemosis was noted in both treated eyes 1 h after treatment persisting in one treated eye at the 24 h observation. Minimal discharge was noted in both treated eyes at the 1 h observation.
One treated eye appeared normal at the 48 h observation and the other treated eye appeared normal at the 72 h observation.

Other effects:

No further local or systemic effects were reported.
No gain in body weight was noted in one animal and bodyweight loss (-20 g) was noted in the other animal during the study.

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, C18-unsatd., dimers, di-Me esters, hydrogenated was tested in rabbits in a GLP-compliant study following EU Method B.4 (Weterings and Daamen, 1987). The undiluted test material (0.5 mL) was applied to the intact skin of 3 female rabbits for 4 h under semiocclusive conditions. Skin reactions were evaluated at intervals up to 14 days after treatment. Forty minutes after test substance removal, the exposed skin showed well-defined erythema and slight swelling in two animals and very slight erythema and edema in the third animal. The erythema varied between very slight and well-defined during the following days and had disappeared on Day 14 in all three animals. Edema persisted until the 72 h observation time in all three rabbits. No signs of systemic intoxication were observed in any of the rabbits. The individual mean erythema and edema scores after 24-72 h were 1.0/1.7/1.3 and 1.0/1.0/1.0, respectively.

Based on the study results, the test substance is considered to be not irritating to the skin.

No evidence of skin irritation was observed in the Mouse Local Lymph Node Assay conducted with Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated (Bradshaw, 2012).

Eye irritation

The irritancy potential of Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated to the rabbit eye was assessed in a GLP-compliant study performed according to OECD guideline 405 (Bradshaw, 2012). A volume of 0.1 mL of the undiluted test material was applied into the conjunctival sac of the right of one animal. Ocular reactions were evaluated 1, 24, 48 and 72 h after treatment. Only minimal conjunctival redness, chemosis and discharge were observed, which were fully reversible within 72, 48 and 24 h, respectively. After consideration of the ocular responses produced in the first treated animal, a second animal was treated. Eye reactions in the second animal were limited to minimal conjunctival redness at the 1 and 24 h observations and minimal chemosis and discharge observed 1 h after treatment. No effects on cornea and iris were noted. No clinical signs of toxicity and no adverse effects on body weight were seen. The individual mean conjunctivae/chemosis scores after 24-72 h were 0.7/0.3 and 0.3/0.0, respectively.

The test material is therefore considered to be not irritating to the eye.

Conclusions for irritation / corrosion

The substance Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated has been tested for skin and eye irritation in rabbits. Dermal and ocular reactions were observed, but overall the effects were slight, fully reversible and therefore not sufficient for classification.

Based on the available data, the substance is considered to be not irritating to the skin and eye.

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, C18-unsatd., dimers, di-Me esters, hydrogenated 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.