Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15.May.1996-29.May.1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
TEST MATERAL
Identification, reference : Matière Première Ref CS61701
Appearance: pale yellow liquid
Quantity received, packaging : 150g, 2 plastic jars
Date received: April 29, 1996
Laboratory reference: 96-1344
Analytical sheet : not supplied
Homogeneity test : not required for less than 28 days studies
Storage : at room temperature, away from the light
The test report only concerns the material to be tested
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test system
Species, strain, supplier : Albino Rat, Sprague Dawley OFA, IFFA-CREDO (69210 - L'ARBRESLE, FRANCE).
Reason for species selection : the Rat is the animal chosen by the regulatory authorities to evaluate the safety of drugs and chemicals.
Number and sex : 10, 5 males and 5 females
Age, weight: about 6 weeks, weight between 182 g and 199 g (males) and 160 g and 179g (females)
Acclimation : at least 5 days
Housing, diet: 5 animals by sex in polypropylene cages (310 x 465 x 190) in accordance with the requirements of the 86/609/EEC guideline. Complete pelleted rat maintenance diet UAR A04-10 (91360-EPINAYSURORGE, FRANCE).
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
Animals have been fasted prior to substance administration by withholding food overnight. They receive by gavage, according to the bodyweight, the product diluted in distilled water at the dose of 5000 mg/kg under a volume of 10 ml/kg.
Reason for route of administration : Oral gavage is the route of choice for estimating potential adverse effects resulting from accidental oral ingestion.
Doses:
5000 mg/kg under a volume of 10 ml/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
a clinical observation is carried out at least once a day in order to evaluate the general appearance, the behaviour and vegetative functions of the animals. An individual clinical observation is realized one hour after treatment. The continuous observations during the five following hours are renewed each following day.
body weight are taken just prior to the test animal administration (D1) and again 3, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
At termination of the 14 observation days, the reats are sacrificed after barbituric anaesthesia then autopsied. All abnormalities are recorded. No tissue is saved.
Preliminary study:
no
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
No modification in the aspect, behaviour or vegetative functions is observed in the animals, 1 hour after the treatment (table 1) or during the 5 following hours. The daily examinations which are repeated during next 13 consecutive days, fail to reveal any alteration in the general appearance and behaviour of the animals.
Body weight:
The individual growth weight of all the animals (males and females) is normal and regular.
The mean weight gain 14 days after the treatment appears satisfactory for this animal species.
Other findings:
Post mortem examinations:
The gross necropsy of the animals 14 days after the treatment does not show any visible organic or tissular lesions leading us to suspect a possible systemic toxicity of the product.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions adopted, the oral LD0 of the test material Matiere Première Ref. CS61701 in male and female Rat is higher than 5000 mg/kg.
According to the 67/548/EEC directive, the test substance is unclassified if swallowed.
Executive summary:

The single oral administration of the substance Matière Première Ref. CS61701 in the male and female Rat at the dose of 5000 mg/kg:

- does not cause any death, - has no significant toxic effect on the animals' behaviour or vegetative functions, - does not modify their weight growth, - does not cause any gross lesions visible at autopsy.

Under the experimental conditions adopted, oral LD0 of the test substance is higher than 5000 mg/kg in the rat.

According to the 67/548/EEC directive, the test substance is unclassified if swallowed.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-01-14 to 2004-01-29
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
12 Sprague Dawle y rats (SPF Caw) originating from Elevage Janvier (53940 Le Genest-St-Isle –France), were used after a 5 to 6-day acclimatisation
period. At the beginning of the study, the animals weighted between 184g and 209g (males) and between 165g and 178g (females).

Environmental parameters for the treated group:
- temperature: between 22°C and 24°C
- relative humidity: between 30% and 51%
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The animals of Group 2, received an effective dose of 2000 mg/kg body weight of product, administered by force-feeding under a volume of 1.84 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
2000 mg/kg body weight of product
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
The study was carried out between 14 January 2004 and 29 January 2004, in PHYCHER Bio développement, according to the experimental protocol Ref. TAO423-version December 2000, established according to the O.E.C.D. guideline N° 423 dated 03.22.1996 concerning acute oral toxicity and the test method B.1ter of the Directive N° 96/54/EC dated 07.30.1996.
The animal control group was performed between 13 January 2004 and 28 January 2004 according to the same experimental conditions, with administration of 2000 mg/kg body weight of the control product (Distilled water), under a volume of 2 mL/kg body weight.
Statistics:
no data
Preliminary study:
no preliminary study
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study
Clinical signs:
No clinical signs related to the administration of the test product were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the product Proteol APL is higher than 2000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the product Proteol APL must not be classified.
Executive summary:

The product Proteol APL was administred to a group of 6 Sprague Dawley rats (3 males and 3 females) at the single dose of 2000 mg/kg body weight according to the experimental protocol established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated March 22nd, 1996 and the test method B.1ter of the Directive N°96/54/EC dated July 30th, 1996. No mortality occurred during the study. No clinical signs related to the administration of the test product were observed. The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the product Proteol APL is higher than 2000 mg/kg body weight by oral route in the rat. According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the product Proteol APL must not be classified

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH
Registered substance (as identified in Section 1.1 identification) has similar chemical structure as the others members of the Category "Amino Acid Alkyl Amides, Sodium or
Potassium Salts" (the source chemicals).

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” has been developed and evaluated to cover the assessment of the intrinsic properties of several similar
substances within the context of REACH Regulation. The Category includes sodium or potassium salts of amino acid alkyl amides, with a carbon chain length range of C6-C16 and an
aminoacidic pool of not selected aminoacids reflecting the natural distributions of aminoacids in various vegetables and cereals.


1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The Category has been built up considering the common chemical structure of its members. They are UVCB substances and they share the following features:
- they are salts of amino acid alkyl amides
- they are sodium or potassium salts
- the carbon chain length ranges between C6 and C16
- the carbon chain derives from cocoyl or lauroyl fatty acids
- the aminoacidic part of the molecules comes from a pool of aminoacids
- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

Overall, the Category was formed on the hypothesis that substances sharing this common chemical structure can be considered analogues and can share intrinsic properties too. No
trends in properties is expected, except for those physicochemical properties depending on the carbon chain length.

2. CATEGORY APPROACH JUSTIFICATION
These substances share (i) eye damage and (ii) the absence of significant systemic toxicity.
Key result
Remarks on result:
other: Absence of acute toxicity.
Remarks:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not acutely toxic.
Interpretation of results:
GHS criteria not met
Conclusions:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not acutely toxic.

A collection of the acute toxicity values is available for category members. Category members were investigated performed by means oral administration. All data support the absence of acute toxicity (LD50 oral rat > 2 000 mg/kg bw).

According to Regulation (EC) n. 1272/2008, the study results indicate that the registered substance should not be classified for acute oral toxicity because data are judged as "conclusive but not sufficient for classification".
Executive summary:

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” was formed on the hypothesis that substances sharing common chemical structure can be considered analogues and can share intrinsic properties too.

Based on this assumption, this property may be assessed using available data  for the category members.

The category has been assessed for members characterized by:

- sodium or potassium salts

- the carbon chain length ranges between C6 and C16

- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8.January.2008-22.January.2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline, GLP study
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:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
Sponsor's identification: LCE07106
Container: plastic flask (n=1)
Quantity: 184.84 g (container + contents)
Batch n° 0715200018
Production date: 01 June 2007
Date received: 21 December 2007
Form: liquid
Coulour: yellow
Storage: Room temperature
Re-test: 31 May 2009
Purity: 52.5% (dry extract)
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals
Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle
– France), were used after an acclimatisation period of at least five days. At the beginning of the study,
the animals of the treated group weighed between 212 g and 234 g (males) and between 183 g and
219 g (females) and were 6-8 weeks old.
Group 1 (control): 5 male rats Rm0096 to Rm0100
and 5 female rats Rf0101 to Rf0105
Group 2 (treated): 5 male rats Rm0116 to Rm0120
and 5 female rats Rf0121 to Rf0125

Housing
During the treatment, the animals were kept in individual cage. At D3, the animals were put into their
cage by 2 or 3. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel
mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage
was installed in conventional air conditioned animal husbandry; the environmental conditions were:
- temperature : between 20 °C and 23 °C
- relative humidity : between 32 % and 62 %
- lighting time: 12 hours daily

Food and drink
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).
Type of coverage:
other: under porous gauze dressing
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Dose and administration mode
Animals from Group 2 received by topical application, under porous gauze dressing, an effective dose
of 2000 mg/kg body weight of LCE07106, under a volume of 1.81 mL/kg body weight, during 24
hours. After 24-hour exposure period, the gauze dressings were removed and the treated areas were
rinsed with distilled water.
Animals from Group 1 received in the same experimental conditions the control item (distilled water)
under a volume of 2 mL/kg body weight.
Duration of exposure:
24 h
Doses:
Group 2 (treated group): 2000 mg/kg body weight (1.81 ml/kg body weight) (LCE07106)
Group 1 (control): 2 ml/kg body waight (distilled water)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Examinations of the animals
Daily examination
Systematic examinations were carried out to identify any behavioural or toxic effects on the major
physiological functions 5 days after administration of the test solution.
This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the
observation sheet.
These observations were compared to control data.
Observations and a mortality report were then carried out every day for 14 days.

Periodical examinations
The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and
D14.
Weight changes were calculated and recorded.

Examination at the end of the test
On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to
fatal levels. Macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting
macroscopic anomalies can be removed and preserved in view to microscopic exanimations.
Statistics:
no data
Preliminary study:
no preliminary study
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No systemic clinical signs related to the administration of the test item were observed.
A very slight erythema was noted on the treated area in 4 female rats since D2. These reactions were
totally reversible between D3 and D4. A slight dryness was noted in the same animals at D3. These
reactions were totally reversible between D4 and D8.

Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Other findings:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item LCE07106 is higher than 2000 mg/kg body weight by dermal route in the
rat.
According to the criteria for classification, packaging and labelling of dangerous substances and
preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item
LCE07106 must not be classified. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not
be classified in category 4. No signal word and hazard statement are required.
Executive summary:

The test item LCE07106 was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5

females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on

the basis of the official method as defined in the O.E.C.D. guideline. n° 402 dated February 24th, 1987

and the test method B.3 of the directive. n° 92/69/EEC.

No mortality occurred during the study.

No systemic clinical signs related to the administration of the test item were observed.

A very slight erythema was noted on the treated area in 4 female rats since D2. These reactions were

totally reversible between D3 and D4. A slight dryness was noted in the same animals at D3. These

reactions were totally reversible between D4 and D8.

The body weight evolution of the animals remained normal throughout the study, similar between

treated and control animals.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related

changes.

In conclusion, the LD50 of the test item LCE07106 is higher than 2000 mg/kg body weight by dermal

route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and

preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item

LCE07106 must not be classified. No symbol and risk phrase are required.

In accordance with the Globally Harmonized System (COM(2007)355 final), the test item needs not

be classified in category 4. No signal word and hazard statement are required.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-06-03 to 2008-06-17
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): LCE08086
- Physical state: Liquid
- Analytical purity: 31% (dry extract)
- Purity test date: 2008-03-29
- Lot/batch No.: 0807000020
- Expiration date of the lot/batch: 2001-03-10
- Storage condition of test material: Room temperature
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (F-53940 Le Genest St Isle), were used after an acclimatation period of at least five
days. At the beginning of the study, the animals of the treated group weighed between 211g and 257g (males) and between 202g and 220g
(females) and were 7-8 weeks old.
Housing:
During treatment, the animals were kept in individual cage. At D3, the animals were put into their cage by 2 or 3. The rats were kept in
solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventionnal air conditionned animal husbandry; the environmental conditions were:
- Temperature: between 41% and 69%
- Relative humidity: between 41% and 69%
- Lighting time: 12 hours daily
- Rate of air exchange: at least ten changes per hour

Food and drink:
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Animals received by topical application, under porous gauze dressing, an effective dose of 2000 mg/kg body weight of LCE08086, administrated
under a volume of 1.83 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressing were removed.
Animals from control group received in the same experimental conditions the control Item (Liquid paraffin) under a volume of 2.32 mL/kg body body weight
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight (1.83 mL/kg body weight)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Systemic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 5 days after administration of the test item.
This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the examination sheet.
These observation were compared to control data.
Observations and mortality report were then carried out every day for 14 days.

The animals were weighed on day D0 (just before administrating the test item) then on D2, D7 and D14.

On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets.
Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
Statistics:
no data
Preliminary study:
no preliminary study performed
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study
Clinical signs:
No systemic clinical signs related to the administration of the test item were observed.
A slight to well defined erythema was noted, on the treated area, 24 hours after the test item administration in four treated female rats (4/5). The
treated areas have recovered a normal aspect between D2 and D4.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.
Gross pathology:
No gross pathology
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item LCE0806 is higher than 2000 mg/kg body weight by dermal route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCE08086 must not be classified. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required.
Executive summary:

The test item LCE08086 was applied onto the intact skin of 10 sprague Dawley rats (5 males and 5 femalles) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3 of the directive n°92/69/EEC.

No mortality occured during the study.

No systemic clinical signs related to the administration of the test item were observed.

A slight to well defined erythema was noted, on the treated area, 24 hours after the test item administration in four treated female rats (4/5). The treated areas have recovered a normal aspect between D2 and D4.

The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals.

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item LCE0806 is higher than 2000 mg/kg body weight by dermal route in the rat.

According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCE08086 must not be classified. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required.

Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH
Registered substance (as identified in Section 1.1 identification) has similar chemical structure as the others members of the Category "Amino Acid Alkyl Amides, Sodium or
Potassium Salts" (the source chemicals).

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” has been developed and evaluated to cover the assessment of the intrinsic properties of several similar
substances within the context of REACH Regulation. The Category includes sodium or potassium salts of amino acid alkyl amides, with a carbon chain length range of C6-C16 and an
aminoacidic pool of not selected aminoacids reflecting the natural distributions of aminoacids in various vegetables and cereals.


1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The Category has been built up considering the common chemical structure of its members. They are UVCB substances and they share the following features:
- they are salts of amino acid alkyl amides
- they are sodium or potassium salts
- the carbon chain length ranges between C6 and C16
- the carbon chain derives from cocoyl or lauroyl fatty acids
- the aminoacidic part of the molecules comes from a pool of aminoacids
- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

Overall, the Category was formed on the hypothesis that substances sharing this common chemical structure can be considered analogues and can share intrinsic properties too. No
trends in properties is expected, except for those physicochemical properties depending on the carbon chain length.

2. CATEGORY APPROACH JUSTIFICATION
These substances share (i) eye damage and (ii) the absence of significant systemic toxicity.
Key result
Remarks on result:
other: Absence of acute toxicity.
Remarks:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not acutely toxic.
Interpretation of results:
GHS criteria not met
Conclusions:
Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) are deemed to be not acutely toxic.

A collection of the acute toxicity values is available for category members. Category members were investigated performed by means dermal administration. All data support the absence of acute toxicity (LD50 oral dermal > 2 000 mg/kg bw).
According to Regulation (EC) n. 1272/2008, the study results indicate that the registered substance should not be classified for acute dermal toxicity because data are judged as "conclusive but not sufficient for classification".
Executive summary:

The category “Amino Acid Alkyl Amides, Sodium or Potassium Salts” was formed on the hypothesis that substances sharing common chemical structure can be considered analogues and can share intrinsic properties too.

Based on this assumption, this property may be assessed using available data  for the category members.

The category has been assessed for members characterized by:

- sodium or potassium salts

- the carbon chain length ranges between C6 and C16

- the aminoacids pool reflects the natural distributions of aminoacids in various vegetables and cereals.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Category members (Amino Acid Alkyl Amides, Sodium or Potassium Salts) does not have significant acute toxicity.

Justification for classification or non-classification

A collection of the acute toxicity values is available for category members. All found values are listed below.

EC number

LD50oral/dermal

S1 - EC: 918-984-3

LD50oral rat > 2 000 mg/kg bw

S2 - EC: 927-837-2

LD0> 5 000 mg/kg bw

 S1 - EC: 918-984-3  LD50 dermal rat > 2 000 mg/kg bw
 S2 - EC: 927-837-2  LD50 dermal rat > 2 000 mg/kg bw

 

Overall, registered substance has a LD50 oral/dermal rat > 2 000 mg/kg bw.

According to Regulation (EC) n. 1272/2008, the study results indicate that the registered substance should not be classified for acute oral toxicity because data are judged as "conclusive but not sufficient for classification".

According to Regulation (EC) n. 1272/2008, the study results indicate that the registered substance should not be classified for acute dermal toxicity because data are judged as "conclusive but not sufficient for classification".

According to Regulation (EC) n. 1272/2008, the registered substance should not be classified for acute inhalation toxicity because of data lacking