N-(dodecylphenyl)naphthalen-1-amine

Endpoint summary

Description of key information

Acute toxicity: oral 

The discriminatory dose was identified as 2000 mg/kg bodyweight.

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Acute toxicity: dermal

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 May 1999 and 1 June 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

OECD Guidelines for Testing of Chemicals No. 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 July 1992)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

Method B1 bis in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Specific details on test material used for the study:

No further details specified

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Male and female Sprague-Dawley CD (Crl : CD (SD) IGS BR) strain rats supplied by Charles River (UK) Ltd, Margate, Kent, UK were used. At the start of the study the males weighed 219 to 232g, and the females 201 to 232g, and were eight to twelve weeks old. After a minimum acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with wood flakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

For the purpose of the study the test material was freshly prepared, as required, as a solution in arachis oil BP. The preparations were mixed thoroughly using a vortex mixer.

Doses:

Preliminary Study: 500 & 2000 mg/kg
Main Study (Limit Study): 2000 mg/kg

No. of animals per sex per dose:

Preliminary Study: 1 animal/sex/dose
Main Study: 5 animals/sex

Control animals:

no

Details on study design:

Preliminary Study
Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and then daily for seven days. Morbidity and mortality checks were made twice daily.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.

Main Study (Limit Study)
Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 1, 2, 3, 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Statistics:

Data evaluations included the relationship, if any, between the animals' exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. The 'discriminatory dose' was also identified. This is the highest of the four fixed dose levels which can be administered without causing compound-related mortality (including humane kills). If possible the signs of evident toxicity were also identified. Evident toxicity is defined as the toxic effects which are of a severity such that administration at the next highest level could result in mortality.

Preliminary study:

There were no deaths at dose levels of 500 and 2000 mg/kg bodyweight.
Clinical signs of toxicity noted in animals treated with 2000 mg/kg were piloerection and/or hunched posture.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

Hunched posture was noted in three female animals during the day of dosing and/or one day after dosing. No other clinical signs of toxicity were noted during the study.

Body weight:

All animals showed expected gains in bodyweight over the 14-day study period.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No further findings noted in the study report.

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE PRELIMINARY STUDY

DOSE LEVEL mg/kg	Animal Number and Sex	Hours Post Dosing (Day 0)				Day Number
		½	1	2	4	1	2	3	4	5	6	7
500	1-0 Male	0	0	0	0	0	0	0	0	0	0	0
	2-0 Female	0	0	0	0	0	0	0	0	0	0	0
2000	3-0 Male	0	0	0	HP	H	0	0	0	0	0	0
	4-0 Female	0	0	0	H	H	0	0	0	0	0	0

0 = no signs of systemic toxicity

H = hunched posture

P = pilo-erection

 

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE LIMIT STUDY

DOSE LEVEL mg/kg	Animal Number and Sex	Hours Post Dosing (Day 0)				Day Number
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	5-0 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	5-1 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	5-2 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	5-3 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	5-4 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	6-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	6-1 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	6-2 Female	0	0	0	H	H	0	0	0	0	0	0	0	0	0	0	0	0	0
	6-3 Female	0	0	H	H	H	0	0	0	0	0	0	0	0	0	0	0	0	0
	6-4 Female	0	0	0	0	H	0	0	0	0	0	0	0	0	0	0	0	0	0

0 = no signs of systemic toxicity

H = hunched posture

 

INDIVIDUAL BODYWEIGHTS AND BODYWEIGHT CHANGES IN THE LIMIT STUDY

DOSE LEVEL mg/kg	Animal Number and Sex	Bodyweight (g) at Day						Increment (g) During Days
		0	1	2	3	7	14	0-1	1-2	2-3	3-7	7-14
2000	5-0 Male 5-1 Male 5-2 Male 5-3 Male 5-4 Male 6-0 Female 6-1 Female 6-2 Female 6-3 Female 6-4 Female	219 223 232 222 224 209 232 201 229 224	224 230 242 226 228 212 239 203 235 229	232 243 258 234 240 220 251 208 248 238	235 248 262 238 244 221 245 208 249 236	252 280 300 270 275 233 268 216 267 249	293 323 354 308 311 245 292 218 303 272	5 7 10 4 4 3 7 2 6 5	8 13 16 8 12 8 12 5 12 9	3 5 4 4 4 1 6 0 1 -2	17 32 38 32 31 12 23 8 18 13	41 43 54 38 36 12 24 2 36 23

 

INDIVIDUAL NECROPSY FINDINGS IN THE LIMIT STUDY

DOSE LEVEL mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
2000	5-0 Male 5-1 Male 5-2 Male 5-3 Male 5-4 Male 6-0 Female 6-1 Female 6-2 Female 6-3 Female 6-4 Female	Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14	No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected

 

Interpretation of results:

GHS criteria not met

Conclusions:

The discriminatory dose was identified as 2000 mg/kg bodyweight.
The acute oral median lethal dose (LD50) of the test material, APAN, in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.
The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification under EC labelling regulations. No symbol or risk phrase are required.

Executive summary:

A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method complied with that described in the OECD Guidelines for Testing of Chemicals No. 420 "Acute Oral Toxicity – Fixed Dose Method" (adopted 1 7 July 1 992) and Method B 1 bis in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

 

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

 

Following a preliminary study in which there were no deaths at dose levels of 500 and 2000 mg/kg, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a solution in arachis oil BP at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross necropsy.

 

There were no deaths. Hunched posture was noted in three female animals. No other clinical signs of toxicity were noted during the study.

 

All animals showed expected gains in bodyweight during the 14-day study period.

 

No abnormalities were noted at necropsy.

 

The discriminatory dose was identified as 2000 mg/kg bodyweight.

 

The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification under EC labelling regulations. No symbol or risk phrase are required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1 - GLP accredited laboratory study in accordance with OECD Guideline 420 and EU Method B1 bis.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 May 1999 and 31 May 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

OECD Guidelines for Teesting of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

Method B3 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

No further details specified in the study report.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five male and five female Sprague-Dawley CD (Crl : CD@ (SD) IGS BR) strain rats supplied by Charles River (UK) Ltd, Margate, Kent were used. At the start of the study the males weighed 200 to 207g, and the females 202 to 2288, and were approximately eight to twelve weeks old. After a minimum acclimatisation period of five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
The animals were housed in suspended polypropylene cages furnished with wood flakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
Free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary clippers.
The appropriate amount of the test material, as received, was applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area) using a graduated syringe. A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The animals were caged individually for the 24-hour exposure period. Shortly after dosing the dressings were examined to ensure that they were securely in place.
After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were returned to group housing for the remainder of the study period.

Duration of exposure:

24-hour.

Doses:

Rats was treated with the test material at a dose level of 2000 mg/kg

No. of animals per sex per dose:

A group of five male and five female rats was treated with the test material.

Control animals:

no

Details on study design:

The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
After removal of the dressings and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored.
Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Statistics:

Not specified

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

No signs of systemic toxicity were noted during the study.

Body weight:

All animals showed expected gain in bodyweight during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No signs of dermal irritation were noted during the study

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA

Dose Level mg/kg	Animal Number and Sex	Effect Noted After Dosing (Hours)				Effects Noted During Period After Dosing (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-1 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-2 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-3 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	1-4 Male	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-0 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-1 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-2 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-3 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2-4 Female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 0 = no signs of systemic toxicity

 

INDIVIDUAL DERMAL REACTIONS

Dose Level mg/kg	Animal Number and Sex	Observation	Effects Noted After Initiation of Exposure (Days)
			1	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 Male	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	1-1 Male	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	1-2 Male	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	1-3 Male	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	1-4 Male	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	2-0 Female	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	2-1 Female	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	2-2 Female	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	2-3 Female	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0
	2-4 Female	Erythema Oedema Other	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0

0 = no signs of dermal irritation

 

INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT CHANGE

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
2000	1 -0 Male 1 -1 Male 1-2 Male 1-3 Male 1-4 Male 2-0 Female 2-1 Female 2-2 Female 2-3 Female 2-4 Female	200 200 201 202 207 202 228 210 213 218	231 237 246 249 260 209 240 230 234 226	284 286 296 308 330 222 272 243 243 243	31 37 45 47 53 7 12 20 21 8	53 49 50 59 70 13 32 13 9 17

 

INDIVIDUAL NECROPSY FINDINGS

Dose Level mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
2000	1-0 Male 1 -1 Male 1-2 Male 1-3 Male 1-4 Male 2-0 Female 2-1 Female 2-2 Female 2-3 Female 2-4 Female	Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14 Killed Day 14	No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected No abnormalities detected

 

Interpretation of results:

GHS criteria not met

Conclusions:

The acute derma! median lethal dose (LD50) of the test material, APAN, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mglkg bodyweight.
No symbol and risk phrase are required according to EU labelling regulations.

Executive summary:

A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method B3 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

 

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

 

A group of ten animals (five males and five females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight.

The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.

 

There were no deaths. No signs of systemic toxicity or dermal irritation were noted during the study.

All animals showed expected gain in bodyweight during the study.

No abnormalities were noted at necropsy.

 

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

K1 - GLP accredited laboratory study in accordance with OECD Guideline 402 and EU Method B3.

Additional information

Acute toxicity: oral

Following a preliminary study in which there were no deaths at dose levels of 500 and 2000 mg/kg, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a solution in arachis oil BP at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross necropsy.

There were no deaths. Hunched posture was noted in three female animals. No other clinical signs of toxicity were noted during the study.  All animals showed expected gains in bodyweight during the 14-day study period. No abnormalities were noted at necropsy.

The discriminatory dose was identified as 2000 mg/kg bodyweight. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Acute toxicity: dermal 

A group of ten animals (five males and five females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight.

The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination.

There were no deaths. No signs of systemic toxicity or dermal irritation were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Justification for classification or non-classification

Acute toxicity: oral

The discriminatory dose was identified as 2000 mg/kg bodyweight. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification under EC labelling regulations. No symbol or risk phrase are required.

Acute toxicity: dermal 

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EU labelling regulations.