Decyl laurate

Endpoint summary

Description of key information

Skin (read across, rabbit, OECD 404): not irritating

Eye (read across, in vitro, OECD 492): not irritating

Eye (read across, in vivo, rabbit, OECD 405): not 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:

18 Dec - 23 Dec 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only basic data given, test substance purity not specified

GLP compliance:

not specified

Species:

rabbit

Strain:

other: New Zealand

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not required

Duration of treatment / exposure:

single application

Observation period:

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

Number of animals:

3

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

Desquamative reaction, with moderated cutaneous extensive range index for 3 animals from Day 4 to Day 7 was observed.

Table 1: Results of skin irritation study

Observation time	Animal no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	0	0	0	0	1	0
24 h	2	0	2	0	2	0
48 h	1	0	2	0	2	0
72 h	0	0	0	0	2	0
7 d	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	1.0	0	1.33	0	2.0	0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

09 - 16 May 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

(analytical purity of test substance not specified, occlusive exposition).

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive exposition, analytical purity of test material not specified

GLP compliance:

yes

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Germany
- Age at study initiation: 8-12 months
- Weight at study initiation: approx. 2620 g
- Diet: ad libitum (Altromin-Haltungsdiat 2023)
- Water: ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated site of the same animal served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

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

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: inert plastic foil fixed with an adhesive patch (Leukosilk) and a special gauze bandage (Acrylastic)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data


SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The test substance, when administered to rabbit skin for 24h, caused only slight irritations that were fully reversible within 7 days.

Erythema Score

Animal Number	1 h	24 h	48 h	72 h	7 d
102	1	1	1	2	0
128	1	1	0	1	0
129	1	1	0	1	0
130	1	0	0	1	0

 

Edema Score

Animal Number	1 h	24 h	48 h	72 h	7 d
102	1	1	0	0	0
128	0	0	0	0	0
129	2	0	0	0	0
130	0	0	0	0	0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

April 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Data on analytical purity, animal husbandry and the dose applied are missing.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

yes

Remarks:

data on analytical purity, animal husbandry and dose applied are missing

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

other: untreated sites of the same animal served as control

Duration of treatment / exposure:

4 h

Observation period:

5 days
Reading time points: 1, 24, 48 and 72 h, and 5 days

Number of animals:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritant / corrosive response data:

3/3 animals had very slight erythema (grade 1) 1 hour after exposure ended. Very slight oedema (grade 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point, while 2/3 did not have edema at any reading time point. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well defined erythema. The erythema cleared in 1/3 animals within 48 hours and in the remaining 2 within 5 days. All irritation reactions were completely reversible within 5 days.

Table 1: Erythema and edema scores for the individual animals:

Animal No.	Reading time point	Erythema score	Edema score
1	1 h	1	0
	24 h	1	0
	48 h	1	0
	72 h	1	0
	5 d	0	0
2	1 h	1	0
	24 h	1	0
	48 h	0	0
	72 h	0	0
	5 d	0	0
3	1 h	1	1
	24 h	2	1
	48 h	1	1
	72 h	1	1
	5 d	0	0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

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

Study period:

19 Dec - 21 Dec 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: only basic data given, lack of details on test substance

GLP compliance:

not specified

Species:

rabbit

Strain:

other: New Zealand

Vehicle:

not specified

Controls:

not specified

Duration of treatment / exposure:

No data

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Reversibility:

other: not applicable

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Reversibility:

other: not applicable

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Reversibility:

other: not applicable

Remarks on result:

not measured/tested

Irritant / corrosive response data:

At the 1-hour reading time point slight to well-defined conjunctivae (score 1-2) was noted in 3/3 animals, which persisted as slight conjunctivae (score 1) until 24 h after installation. The eye irritation effects had cleared completely within 48 h. All the scores for both rabbits were 0 for corneal and iridial effects. No scoring was performed for chemosis.

Table 1: Results of eye irritation test

Rabbit No. / sex	Scoring [h]	Cornea	Iris	Conjunctiva
1 / m	1	0	0	1
	24	0	0	1
	48	0	0	0
	72	0	0	0
	7 days	0	0	0
Mean (24, 48, 72 h)		0	0	0.33
2 / m	1	0	0	2
	24	0	0	1
	48	0	0	0
	72	0	0	0
	7 days	0	0	0
Mean (24, 48, 72 h)		0	0	0.33
3 / m	1	0	0	2
	24	0	0	1
	48	0	0	0
	72	0	0	0
	7 days	0	0	0
Mean (24, 48, 72 h)		0	0	0.33

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

15 May - 16 Jul 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 2693 - 2894 g
- Housing: individually in plastic cages with perforated floors
- Diet: standard animal diet (100 g per day), obtained from Hope Farms, Woerden (LK-01, pellet diameter 4 mm)
- Water: tap-water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 60 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

Single eye instillation

Observation period (in vivo):

72 hours (in the absence of any persistent sign of irritation)

Reading time points: 1, 24, 48 and 72 hours after instillation

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

2 out of 3 animals showed only slight swelling of the blood-vessels in the conjunctivae 1 hour after instillation. The effects were fully reversible 24 hours after instillation. The fluorescein analysis 24 hours after instillation did not reveal any epithelial damage.

Other effects:

Signs of systemic intoxication were not observed.

Table 1: Results of eye irritation test

Rabbit No. / sex	Scoring [h]	Cornea	Iris	Conjunctiva
				Redness	Chemosis
1 / f	1	0	0	1	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
Mean (24, 48, 72 h)		0	0	0	0
2 / f	1	0	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
Mean (24, 48, 72 h)		0	0	0	0
3 / f	1	0	0	1	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
Mean (24, 48, 72 h)		0	0	0	0
Group mean		0	0	0	0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

17 July - 30 Jan 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

9 October 2017

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hess. Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany

Species:

human

Strain:

other: EpiOcularTM (OCL-200-EIT)

Details on test animals or tissues and environmental conditions:

- Justification of the test method and considerations regarding applicability
The EpiOcularTM Eye Irritation Test (EIT) predicts the acute ocular irritation potential of chemicals by measurement of its irreversible tissue damage caused by cytotoxic effects in the human cornea model. The EpiOcular ™ Eye Irritation Test (EIT) was validated by the European Union Reference laboratory for Alternatives to Animal Testing (EURL ECVAM) and cosmetics Europe between 2008 and 2013. It is utilized for the classification and labelling of chemicals concerning their eye irritation potential. The EpiOcularTM EIT is intended to differentiate substances that require “no classification" as eye irritant from those that require labelling as either GHS category 1 or 2 for serious eye damage respective eye irritation potential.

- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live
The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells, which progressively flatten out as the apical surface of the tissue is approached, analogous to the normal in vivo corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) were cultured on specially prepared cell culture inserts (MILLICELL®, 10 mm Ø). Analysis for tissue functionality and for potential contaminants was passed.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 50 µL
- Concentration: undiluted

Duration of treatment / exposure:

30 min

Duration of post- treatment incubation (in vitro):

120 min

Number of animals or in vitro replicates:

2

Details on study design:

- Details of the test procedure used :
EpiOcularTM tissue model was used. After the assessment and exclusion of direct MTT reduction and colouring potential of the test substance, the well plates were prepared and the tissues were pre-incubated in warm medium under standard culture conditions (37 ± 1.5 °C, 5 ± 0.5 % CO2 and 95 % relative humidity). After overnight incubation, the tissues were pre-wetted with 20 μL DPBS buffer (Ca2+ Mg2+ free) and then incubated at standard culture conditions for 30 min. 50 μL of the controls and the neat test substance were then applied and incubated for 30 min at standard culture conditions. After exposure the tissue constructs were thoroughly rinsed and transferred to fresh medium for an immersion incubation at room temperature. Afterwards, the tissues were transferred to fresh medium and incubated for 120 min at standard culture conditions, prior to determination of the cytotoxic (irritancy) effect. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment.

- RhCE tissue construct used, including batch number :
Keratinocyte strain: 4F1188, Lot Number: 27002

- Doses of test chemical and control substances used :
50 μL of undiluted test substance, 50 μL of demineralised water (negative control), 50 μL of methyl acetate (positive control)

- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods:
30 min at 37.0 ± 1.5 °C, 12 min immersion incubation at room temperature, 120 min at 37 ± 1.5 °C post-exposure incubation

- Number of tissue replicates used per test chemical and controls (positive and negative control) : 2

- Wavelength used for quantifying MTT formazan : 570 nm

- Description of the method used to quantify MTT formazan : The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with a plate reader (Versamax® Molecular Devices, Ismaning, Germany). Then the mean OD of the blank isopropanol (OD Blk) was calculated, followed by the subtraction of mean OD Blk of each value of the same experiment (corrected values).
The mean OD of the two replicates for each tissue the mean OD of the two relating tissues for controls and test substance were then calculated.

To calculate the relative absorbance, the following equation was used: viability (%) = (OD corrected of test substance or positive control/ OD corrected of mean negative control)*100

- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model :

The in vitro eye irritation test is considered valid if it meets the following criteria:
a) mean OD570 of the negative control: > 0.8 and < 2.5
b) mean relative tissue viability of the positive control: < 50% relative to the negative control.
c) variation within replicates: <20%

If the test item-treated tissue viability is > 60% relative to the negative control treated tissue viability, the test item is labeled non-irritant (no Category according to UN GHS).
If the test item-treated tissue viability is ≤ 60% relative to negative control treated tissue viability, the test item is labeled irritant (Category 2 or Category 1 according to UN GHS; no differentiation between the categories possible).

- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria : negative contrtol range: 1.27 - 2.16; positive control range: 6.9 - 43.4%

- Complete supporting information for the specific RhCE tissue construct used :
Tissue viability: 1.269 ± 0.039 (accepted range: 1.1 - 3.0)
Barrier function: ET-50: 24.36 min (accepted range: 12.2 - 37.5)

Irritation parameter:

other: mean viability (%)

Run / experiment:

mean value of test substance

Value:

95

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Irritation parameter:

other: mean viability (%)

Run / experiment:

mean value of positive control

Value:

36.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

DEMONSTRATION OF TECHNICAL PROFICIENCY: yes, but not in this report

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, mean OD = 1.691 (> 0.8 and < 2.5)
- Acceptance criteria met for positive control: yes, % viability = 36.5% (< 50%)
- Range of historical values if different from the ones specified in the test guideline: 0.6 - 2.1% (< 20%)

Table 1: Results of MTT assay

	Tissue No.	OD570	Mean (OD570)	Mean (OD570) - blank	Mean tissue viability (% of negative control)
Negative control	1	1.674	1.714	1.676	99.1	100
		1.753
	2	1.735	1.744	1.706	100.9
		1.753
Positive control	1	0.626	0.660	0.622	36.8	36.5
		0.693
	2	0.647	0.649	0.611	36.2
		0.652
Test substance	1	1.614	1.626	1.588	93.9	95.0
		1.638
	2	1.676	1.662	1.624	96.1
		1.649

 OD = optical density

Interpretation of results:

other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Analogue justification

There are no available data on the skin and eye irritation effects of Decyl laurate (CAS 36528-28-6). The assessment was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

 

Skin irritation

CAS 20292-08-4

A skin irritation study was performed with 2-hexyl laurate (CAS 20292-08-4), according to a protocol similar to OECD guideline 404 (key study, 1996). An unknown amount of the test substance was applied to the shaved skin of 3 male rabbits for 4 hours. The local skin effects were scored 1, 24, 48 and 72 h, and 7 days after exposure ended. At the 1-hour reading time point, 1/3 animals had slight erythema (score 1). At the 24-hour reading time point 3/3 rabbits showed well-defined erythema (score 2), which persisted as slight to well-defined erythema (score 1-2) for 48 hours in 3/3 animals and was still present in 1/3 animals at the 72-hour reading time point. No edema was observed at any time point in any animal. All local skin irritation had cleared completely within 7 days after the exposure ended. The mean erythema scores (over 24, 48 and 72 hours) in each animal were 1.0, 1.33 and 2.0 while the mean edema scores (over 24, 48 and 72 hours) were 0, 0 and 0. The test substance is not considered to be irritating to the skin.

 

CAS 3687 -46 -5

An acute skin irritation study was performed with Decyl oleate according to a protocol similar to OECD guideline 404 (supporting study, 1994). The shaved skin of 3 male New Zealand rabbits was treated with 0.5 mL of the test material (no data on purity) for 4 hours under semi-occlusive conditions. The local skin effects were scored 1, 24, 48 and 72 h, and 5 days after patch removal. 3/3 animals had very slight erythema (score 1) 1 hour after exposure ended. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well defined erythema. The erythema cleared in 1/3 animals within 48 hours and in the remaining 2 within 5 days. Very slight edema (score 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point, while in 2/3 animals no edema was observed at any reading time point. All irritation reactions were completely reversible within 5 days. The mean erythema scores (over 24, 48 and 72 hours) for each animal were 1.0, 0.33, and 1.33, while the mean edema scores (over 24, 48 and 72 hours) were 0, 0, and 0. The test substance is not considered to be irritating to the skin.

CAS 135800-37-2

A skin irritation study was performed according to a protocol similar to OECD guideline 404 with Fatty acids, C8-16, 2- ethylhexyl esters (CAS 135800-37-2) (supporting study, 1990). The test substance was applied to the shaved skin of 4 rabbits under occlusive conditions for 4 hours. The local skin effects were scored 1, 24, 48 and 72 h, and 7 days after exposure ended. At the 1-hour reading time point, 4/4 animals had slight erythema (score 1). At the 24-hour reading time point 3/4 rabbits showed slight erythema, which persisted as slight erythema for 48 hours in 1/4 animals. At the 72-hour reading time point, slight to well-defined erythema was observed in 4/4 rabbits. The erythema had cleared completely within 7 days after the exposure ended. Edema was observed in 2/4 animals 1 h after patch removal and 1/4 animals 24 h after patch removal; the effect had cleared completely within 48 hours. The mean erythema scores (over 24, 48 and 72 hours) in each animal were 1.33, 0.66 0.66 and 0.33, while the mean edema scores (over 24, 48 and 72 hours) were 0.33, 0, 0 and 0. The test substance is not considered to be irritating to the skin.

 

Eye irritation in vitro

CAS 17671-26-0

The eye irritation properties of Lauryl nonanoate were tested in an in vitro study according to OECD 492 and in compliance with GLP (key study, 2018). The EpiOcular™ cornea epithelial model was exposed to 50 μL of the neat/ undiluted test substance for 30 minutes and was incubated for another 2 hours after rinsing and removal of the test substance and 12 minutes of post-soak immersion. After treatment with the negative control the absorbance values were well within the required acceptability criterion of OD > 0.8 and < 2.5 thus showing the quality of the tissues. Treatment with the positive control induced a decrease below 50% compared with the negative control value in the relative absorbance thus ensuring the validity of the test system. The viability test (MTT) with the test substance revealed a mean tissue viability of 95% compared with the value of the negative control. Based on the obtained results, Lauryl nonanoate (CAS 17671-26-0) is not eye irritating.

 

Eye irritation in vivo

 

CAS 20292 -08 -4

2-hexyl laurate (CAS 20292-08-4) was examined for its eye irritation potential in a study performed following a protocol similar to OECD guideline 405 (key study, 1996). An unknown amount of undiluted test substance was instilled into one eye of each of 3 rabbits. The animals were observed for 7 days and scoring according to Draize was performed 1, 24, 48, and 72 hours after application. At the 1-hour reading time point slight to well-defined conjunctivae (score 1-2) was noted in 3/3 animals, which persisted as slight conjunctivae (score 1) until 24 h after installation. The eye irritation effects had cleared completely within 48 h. All the scores for both rabbits were 0 for corneal and iridial effects. No scoring was performed for chemosis. Under the conditions of the study, the test substance showed no eye irritating potential.

CAS 92044-87-6

An eye irritation study was performed with Fatty acids, coco, 2-ethylhexyl ester (CAS 92044-87-6) according to OECD guideline 405 (supporting study, 1987). 0.1 mL of the test substance was instilled into the eyes of 3 female New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours after application. The eyes were not rinsed. At the 1-hour reading time point 2/3 rabbits had slight conjunctivae (score 1). The effects had cleared completely by the 24-hour reading time point. No effects on the cornea and iris were noted, and no chemosis was reported at any time point in any animal. The mean cornea score and iris score (over 24, 48 and 72 hours) was 0 for all animals, respectively. The mean conjunctivae score and chemosis score (over 24, 48 and 72 hours) was 0 for all animals, respectively. Based on the results of the study, the test substance is not considered to be irritating to the eyes.

 

Overall conclusion for skin and eye irritation

The available data on suitable source substances did not show any skin or eye irritation effects. Therefore, the target substance Decyl laurate is not expected to be a skin irritant or an eye irritant.

 

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Decyl laurate (CAS 36528-28-6), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

 

Therefore, based on the analogue read-across approach , the available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.