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EC number: 616-248-3 | CAS number: 75627-31-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Solubility in organic solvents / fat solubility
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- Auto flammability
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- Endpoint summary
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
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- Additional ecotoxological information
- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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. - 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).
Reference
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 |
Effects Noted During Period After Dosing |
||||||||||||||||
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 |
Animal Number |
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
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
- 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. - 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).
Reference
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 |
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
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.
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