Poly(oxy-1,2-ethanediyl), .alpha.-[3-[(carboxymethyl)methylamino]-2-hydroxypropyl]-.omega.-(4-nonylphenoxy)-, sodium salt (1:1)

Endpoint summary

Description of key information

An acute oral limit toxicity test on nonylphenol ethoxylate, sarcosine derivative (CAS no 7562-31-5) was performed under GLP according to OECD 402 with validity rating 1. 
Following a sighting test at a dose level of 2448 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight) in one animal, an additional number of four fasted female animals were given a single oral dose of test item at 2448 mg/kg bodyweight, as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study and all animals were subjected to gross necropsy. No substance related findings were seen. This newly performed acute oral test on nonylphenol ethoxylate, sarcosinate derivative (CAS no 75627-31-5) shows a LD50 value of > 2000 mg/kg bw. No classification is therefore needed according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), nor the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
A newly performed acute dermal limit toxicity test is available on nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5). It has validity rating 1 and is performed under GLP and according to OECD 402. In the study a group of ten animals (five males and five females) was given a single, 24 hour, semi occluded dermal application of the test item to intact skin at a dose level of 2448 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). Red/brown staining around the snout was noted in one female during the day of dosing. No other signs of systemic toxicity were noted and no deaths occurred, and the LD50 value was identified as > 2000 mg/kg bw. No classification is therefore needed according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), nor the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

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:

Between 07 August 2012 and 30 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

No analysis was carried out to determine the homogeneity, concentration or stability of the test item formulation. This exception is considered not to affect the purpose or integrity of the study.

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Female Wistar (RccHan™:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an 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. At the start of the study the animals were eight to twelve weeks of age. The bodyweight variation did not exceed ±20% of the bodyweight of the initially dosed animal.
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. 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 (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe.

Doses:

Using available information on the toxicity of the test item, 2448 mg/kg was chosen as the starting dose.

Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (mg/ml) (ml/kg) Female
2448* 244.8 10 1


In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:
Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (mg/ml) (ml/kg) Female
2448* 244.8 10 4

* - Equivalent to 2000 mg active ingredient/kg bodyweight

No. of animals per sex per dose:

1 female at 2448 mg/kg
4 females at 2448 mg/kg

Control animals:

no

Details on study design:

Using available information on the toxicity of the test item, 2448 mg/kg was chosen as the starting dose.
Dose Level(mg/kg) Concentration(mg/ml) Dose Volume(ml/kg) Number of Rats Female
2448* 244.8 10 1
In the absence of mortality at a dose level of 2448 mg/kg, an additional group of animals was treated as follows:
Dose Level(mg/kg) Concentration(mg/ml) Dose Volume(ml/kg) Number of Rats Female
2448* 244.8 10 4
A total of five animals were therefore treated at a dose level of 2448 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight) in the study.
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Clinical observations were made ½, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily.
Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were 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.

* - Equivalent to 2000 mg active ingredient/kg bodyweight

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: 95% confidence limits not given in study report.

Mortality:

Individual mortality data are given in Table 1.
There were no deaths.

Clinical signs:

other: Individual clinical observations are given in Table 1. Hunched posture was noted during the day of dosing in the initial treated animal. There were no signs of systemic toxicity noted in the additional four treated animals.

Gross pathology:

Individual necropsy findings are given in Table 3.
No abnormalities were noted at necropsy.

Evaluation of Data

The test item will be classified according to Annex 3 of the OECD Guidelines for Testing of Chemicals No. 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 December 2001).

Evaluation of data included identification of the number of animals that died during the study (or that were killed for humane reasons), and determination of the nature, severity, onset and duration of the toxic effects. If possible, the signs of evident toxicity were described. Evident toxicity refers to the toxic effects of sufficient severity that administration of the next higher dose level could result in development of severe signs of toxicity and probable mortality. Effects on bodyweights and abnormalities noted at necropsy were also identified.

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD₅₀) of the test item was made.

Table 1              Individual Clinical Observations and Mortality Data

Dose Level mg/kg	Animal Number and Sex	Effects 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
2448Ä	1-0 Female	0	H	H	H	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

Ä=     Equivalent to 2000 mg active ingredient/kg bodyweight

0=     No signs of systemic toxicity

H =      Hunched posture

Table 2              Individual Bodyweights and Bodyweight Changes

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
2448Ä	1-0 Female	158	172	187	14	15
	2-0 Female	169	183	200	14	17
	2-1 Female	171	197	205	26	8
	2-2 Female	170	199	210	29	11
	2-3 Female	168	196	212	28	16

Ä=     Equivalent to 2000 mg active ingredient/kg bodyweight

Table 3              Individual Necropsy Findings

Dose Level mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
2448Ä	1-0 Female	Killed Day 14	No abnormalities detected
	2-0 Female	Killed Day 14	No abnormalities detected
	2-1 Female	Killed Day 14	No abnormalities detected
	2-2 Female	Killed Day 14	No abnormalities detected
	2-3 Female	Killed Day 14	No abnormalities detected

Ä=     Equivalent to 2000 mg active ingredient/kg bodyweight

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2448 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight) (Globally Harmonised Classification System - Unclassified).

Executive summary:

Introduction. The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:

OECD Guidelines for the Testing of Chemicals No. 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 December 2001)

Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008

Method. Following a sighting test at a dose level of 2448 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight), an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2448 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. Hunched posture was noted during the day of dosing in the initial treated animal. There were no signs of systemic toxicity noted in the additional four treated animals.

Bodyweight. All animals showed expected gains in bodyweight.

Necropsy. No abnormalities were noted at necropsy.

Conclusion. The acute oral median lethal dose (LD₅₀) of the test item in the female Wistar strain rat was estimated to be greater than 2448 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight) (Globally Harmonised Classification System-Unclassified).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study is a Klimisch 1 GLP guideline study which has the test substance clearly identified with a certificate of analysis, so the study is of high quality. There is also a pre-GLP study available, performed on a mixture of substances which includes nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5). Based on the limited information of this study with validity rating 4, it is not considered possible to evaluate the GHS classification of the specific components. The overall acute oral toxicity profile of this mixture is considered to be low. This test is therefore used as supporting study.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

Between 15 August 2012 and 29 August 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five male and five female Wistar (RccHan:WIST) strain rats were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an 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. At the start of the study the animals weighed at least 200 g, and were eight to twelve weeks of age. The weight variation did not exceed ±20% of the mean weight for each sex.
The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. 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 (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The calculated volume of test material, as received, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body
surface area) using a graduated syringe.

Duration of exposure:

24 hours

Doses:

2448 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight)

No. of animals per sex per dose:

5 Male
5 Female

Control animals:

not required

Details on study design:

On the day before treatment the back and flanks of each animal were clipped free of hair.
Using available information on the toxicity of the test item, a group of five male and five female rats was treated with the test item at a dose level of 2448 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight).
The appropriate amount of test item, moistened with arachis oil BP, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area). 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 arachis oil BP to remove any residual test item. The animals were returned to group housing for the remainder of the study period.
The animals were observed for deaths or overt signs of toxicity ½, 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 according to the following scale from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31:

EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth) 4

Oedema Formation

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Any other skin reactions, if present were also recorded.
Individual bodyweights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation. All animals were 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.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: 95% confidence limits not reported.

Mortality:

Individual mortality data are given in Table 1.
There were no deaths.

Clinical signs:

other: Individual clinical observations are given in Table 1. Red/brown staining around the snout was noted in one female during the day of dosing. No other signs of systemic toxicity were noted.

Gross pathology:

Individual necropsy findings are given in Table 5.
No abnormalities were noted at necropsy.

Other findings:

Dermal Reactions
Individual dermal reactions are given in Table 2 and Table 3 (attachment 2).
Very slight erythema was noted at the test sites of all animals up to six days after treatment.

Evaluation of Data

Data evaluations included the relationship, if any, between the exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.

Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD₅₀) of the test item was made.

Table 1              Individual Clinical Observations and Mortality Data

Dose Level mg/kg	Animal Number and Sex	Effects Noted After Initiation of Exposure (Hours)				Effects Noted After Initiation of Exposure (Days)
		½	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
2448Å	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	Ss	Ss	Ss	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

Å= Equivalent to 2000 mg active ingredient/kg bodyweight

0= No signs of systemic toxicity                      Ss = Red/brown staining around the snout

Table 4              Individual Bodyweights and Weekly Bodyweight Changes

Dose Level mg/kg	Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Change (g) During Week
		0	7	14	1	2
2448Å	1-0 Male	293	308	336	15	28
	1-1 Male	267	278	292	11	14
	1-2 Male	275	293	316	18	23
	1-3 Male	303	325	345	22	20
	1-4 Male	322	349	378	27	29
	2-0 Female	228	235	243	7	8
	2-1 Female	209	216	222	7	6
	2-2 Female	224	228	229	4	1
	2-3 Female	208	214	219	6	5
	2-4 Female	212	215	218	3	3

Å= Equivalent to 2000 mg active ingredient/kg bodyweight

Table 5              Individual Necropsy Findings

Dose Level mg/kg	Animal Number and Sex	Time of Death	Macroscopic Observations
2448Å	1-0 Male	Killed Day 14	No abnormalities detected
	1-1 Male	Killed Day 14	No abnormalities detected
	1-2 Male	Killed Day 14	No abnormalities detected
	1-3 Male	Killed Day 14	No abnormalities detected
	1-4 Male	Killed Day 14	No abnormalities detected
	2-0 Female	Killed Day 14	No abnormalities detected
	2-1 Female	Killed Day 14	No abnormalities detected
	2-2 Female	Killed Day 14	No abnormalities detected
	2-3 Female	Killed Day 14	No abnormalities detected
	2-4 Female	Killed Day 14	No abnormalities detected

Å= Equivalent to 2000 mg active ingredient/kg bodyweight

Interpretation of results:

other: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2448 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).

Conclusions:

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2448 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).

Executive summary:

Introduction. The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following: OECD Guidelines for the Testing of Chemicals No.402 "Acute Dermal Toxicity" (adopted 24 February 1987) Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008 Method. A group of ten animals (five males and five females) was given a single, 24 hour, semi‑occluded dermal application of the test item to intact skin at a dose level of 2448 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality. There were no deaths.

Clinical Observations. Red/brown staining around the snout was noted in one female during the day of dosing. No other signs of systemic toxicity were noted.

Dermal Irritation. Very slight erythema was noted at the test sites of all animals up to six days after treatment. 

Bodyweight. All animals showed expected gains in bodyweight over the study period.

Necropsy. No abnormalities were noted at necropsy.

Conclusion. The acute dermal median lethal dose (LD₅₀) of the test item in the Wistar strain rat was found to be greater than 2448 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The study is a Klimisch 1 GLP guideline study which has the test substance clearly identified with a certificate of analysis, so the study is of high quality.

Additional information

Two acute studies are available on nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5), both indicating a LD 50 value > 2000 mg/kg bw for the substance. The only report evaluating the oral way of administration is used as key study for this endpoint. This study showed no adverse effects in the acute limit test on 5 female rats dosed at 2000 mg active ingredient/kg bw. The low acute toxicity of the substance is also seen in the available acute dermal toxicity test, where the LD 50 is > 2000 mg/kg bw.Inhalation was not seen as a likely route of exposure and based on the low toxicity profile of the substance from the oral and dermal tests available, it is not considered justified on animal welfare grounds to perform an acute inhalation toxicity study.

Justification for selection of acute toxicity – oral endpoint
Appropriate study of the highest quality.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII, an acute inhalation toxicity study does not need to be conducted if the route of exposure is unlikely. The substance is produced within a ventilated factory with risk management measures in place to limit the exposure. Based on the low toxicity profile of the substance from the oral and dermal tests available, it is not considered justified on animal welfare grounds to perform an acute inhalation toxicity study. Therefore acute inhalation testing is waived.

Justification for selection of acute toxicity – dermal endpoint
Appropriate study of the highest quality.

Justification for classification or non-classification

The two available key studies for both acute oral and acute dermal toxicity endpoints are performed under GLP with a validity rating of 1. These two studies showed no adverse effects at the tested limit dose of 2000 mg/kg bw. Based on the LD50 being > 2000 mg/kg bw and the lack of any effects, nonylphenol ethoxylate, sarcosine derivative (CAS no 7562-31-5) is not classified for acute oral toxicity or acute dermal toxicityaccording to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011), nor the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.