Dodecyl laurate

Endpoint summary

Description of key information

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

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

Eye, rabbit (OECD 405, read across): 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:

11 - 18 Mar 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The exposure was performed under occlusive conditions, the analytical purity of the test substance was not specified.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1981

Deviations:

yes

Remarks:

occlusive exposure

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated skin site of the same animal served as the control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

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

Number of animals:

3 males

Details on study design:

TEST SITE
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was not washed after patch removal

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean over

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibilty not applicable

Irritant / corrosive response data:

1 hour after exposure, all the animals had slight to well-defined erythema, while 2/3 had very slight to slight edema. These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. the edema persisted until the 48-hour reading time point.All skin irritation effects had cleared completely within 72 hours after the exposure ended.

Table 1: Erythema and edema scores for skin irritation of the individual animals at different reading time points:

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	2	1	0	1	1
24 h	1	2	0	0	0	0
48 h	0	1	0	0	0	0
72 h	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.33	1.00	0	0	0	0
Mean value 24 + 48 + 72 h all animals	0.11	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:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting 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

Remarks:

mean over

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean over

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

Remarks:

mean over

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Remarks:

mean over

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 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Basic data given. The test substance was applied under occlusive conditions for 24 hours, no experimental 48 h reading was performed, few data were reported.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

exposure period 24 h, occlusive conditions, no experimental 48 h reading performed, few details reported

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

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:

6 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean over

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 were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean over

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 were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

mean over

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 were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

mean over

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 were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

mean over

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 were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Remarks:

mean over

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 were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritant / corrosive response data:

Intact skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point (see Table 1). No other skin irritation effects were observed in any animals.

Abraded skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point. The skin irritation had cleared within 48 hours.

Table 1: individual erythema and edema scores for intact skin

Observation time	Rabbit No.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
24 h	0	0	1	0	0	0	0	0	0	0	0	0
48 h	No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h	0	0	0	0	0	0	0	0	0	0	0	0

 

Table 2: calculation of mean scores for intact skin

	Rabbit No.
	1		2		3		4		5		6
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24+48+72 h	0	0	0.67	0	0	0	0	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.

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:

supporting study

Study period:

19 Dec - 21 Dec 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

: only basic data given, lack of details on test substance, no chemosis scores determined

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

No rationale for in vivo testing, limited documentation

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, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

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:

weight of evidence

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)

Version / remarks:

adopted in 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 2017

Deviations:

yes

Remarks:

no rationale for in vivo testing; limited documentation details

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:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Remarks:

mean over

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Remarks:

mean over

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Read across justification

There are no available data on the skin and eye irritation effects of Lauryl laurate (CAS 13945-76-1). 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 95912-86-0

A skin irritation study similar to OECD guideline 404 (key study, 1991) was performed with Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0). 0.5 mL of the undiluted test substance was applied to the shaved skin of 3 male rabbits for 4 hours under occlusive conditions. The local skin effects were scored 1, 24, 48, and 72 h after exposure ended. At the 24-hour reading time point 1/3 rabbits showed erythema (score 1), which was fully reversible within 48 hours. Oedema was seen in 1/3 rabbits with score 2 at the 24-hour reading and score 1 at the 48 hour reading, which was fully reversible within 72 hours.

The mean erythema scores (over 24, 48 and 72 hours) were 0.33, 0.0 and 0.0 while the mean oedema scores (over 24, 48 and 72 hours) were 1.0, 0.0 and 0.0. Based on these results, the test substance is not considered to be irritating to the skin.

 

CAS 20292-08-4

A skin irritation study similar to OECD guideline 404 (supporting study, 1996) was performed with 2-ethylhexyl laurate (CAS 20292-08-4). An unknown amount of the test substance was single applied to the skin of 3 male rabbits for an unknown exposure duration. The local skin effects were scored 1, 24, 48 and 72 h, and 7 days after exposure ended. 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 oedema 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) were 1.0, 1.33 and 2.0 while the mean oedema scores (over 24, 48 and 72 hours) were 0.0, 0.0 and 0.0. Based on these results, the test substance is not considered to be irritating to the skin.

 

CAS 3234-85-3

A skin irritation study similar to OECD guideline 404 (supporting study, 1985) was performed with Tetradecanoic acid, tetradecyl ester (CAS 3234-85-3). 0.5 g of the test substance was applied to the shaved and abraded skin of 6 male rabbits for 24 hours of exposure under occlusive conditions. The local skin effects were scored at 24 and 72 h. At the 24-hour reading time point 1/6 rabbits showed erythema (score 1), which was fully reversible at 72-hour reading. No oedema was observed at any time point in any animal. Scores for the omitted 48h reading were assumed to be the same as at 24h reading (worst case assumption).The mean erythema scores (over 24, 48 and 72 hours) were 0.67, 0.0, and 0.0 while the mean oedema scores (over 24, 48 and 72 hours) were 0, 0 and 0. Based on these results, the test substance is not considered to be irritating to the skin.

 

Eye irritation

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.

 

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 (WoE, 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.

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 (supporting 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 iris effects. No scoring was performed for chemosis. Under the conditions of the study, the test substance showed no eye irritating potential.

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 Lauryl laurate (CAS 13945-76-1) 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 Lauryl laurate (CAS 13945-76-1), 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.