Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
08 May - 08 Sep 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 289-339 g (males) and 170-200 g (females)
- Housing: animals were housed in groups of up to three in open macrolon cages type 2000P (TechniPlast).
- Diet: maintenance diet for rats and mice, No. 1324 TPF, ad libitum. Dams received breeding diet for rats and mice, No. 1314 TPF, ad libitum
- Water: sterilized community tap water, ad libitum
- Acclimation period: 14-17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
other: 1% sodium carboxymethyl cellulose + 0,1% Polysorbate 80 (Tween 80), diluted in water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Test item and vehicle preparations were conducted weekly; the test item solution was prepared fresh on the day of application.

VEHICLE
- Justification for use and choice of vehicle (if other than water): As the test item’s solubility in water is poor, corn oil was used as an organic solvent for the preceding dose range finding study. Although the solubility of the test item in corn oil was sufficient, its oral application resulted in severe respiratory effects (laboured breathing, wheezing breath sounds) in all rats of the high dose group (1000 mg/kg body mass). The study director and the study monitor concluded that the physical (high surface activity) rather than the chemical properties of the test material when applied orally in this formulation lead to the effects observed in study. Based on an assessment of the physiochemical properties of the test material an adapted formulation from one of the acute toxicological studies was considered safe for application. The test item was applied as an emulsion in a watery solution at the three dosages specified in the study plan.
- Amount of vehicle (if gavage): 4 mL/kg bw
Details on mating procedure:
- M/F ratio per cage: 1/1
- Length of cohabitation: until indications for mating were detected
- Proof of pregnancy: vaginal plug / sperm in vaginal referred to as Day 0 of pregnancy
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
(P) Males: 2 weeks before mating and continued throughout the mating period until the study was terminated
(P) Females: 2 weeks before mating, the variable time to conception, the duration of pregnancy and at least 4 days after delivery, up to and including the day before scheduled termination of the in-life phase. Therefore the duration of the study following acclimatisation depended on the female performance: 14 days pre-mating, up to 14 days until mating, an average of 21 days of gestation, and a minimum of 4 days of lactation.
Frequency of treatment:
daily, 7 days/week
Remarks:
Doses / Concentrations:
62.5, 250 and 1000 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
12
Control animals:
yes, concurrent vehicle
Details on study design:
- Dose selection rationale: In a previously performed dose range finding study (OECD 407), the test item was administered in corn oil at three dosages up to 1000 mg/kg body mass over a time period of at least 40 days and produced irritating but no observable toxic effects in the test animals. Although its oral application resulted in severe respiratory effects (laboured breathing, wheezing breath sounds) in all rats of the high dose group (1000 mg/kg body mass), it was concluded that the physical (high surface activity) rather than the chemical properties of the test material lead to the effects observed in study. Therefore, the vehicle formulation was changed as described and 1000 mg/kg was determined as high dose for this study.
Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once weekly and once before beginning of application

BODY WEIGHT: Yes
- Time schedule for examinations: once weekly and once before beginning of application. Females during pregnancy: Day 0, 7, 14, 20, within 24h post parturition and Day 4 post partum.

FOOD CONSUMPTION: Yes
- Time schedule: at least once weekly

WATER CONSUMPTION: Yes
- Time schedule: twice weekly
Sperm parameters (parental animals):
Parameters examined in male parental animals: testis weight, epididymis weights. In high dose and control animals additionally performed: histology with special emphasis on stages of spermatogenesis and histopathology of interstitial testicular cell structure.
Litter observations:
STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no

PARAMETERS EXAMINED
The following parameters were examined in offspring: number and sex of pups, live births, stillborn, post-natal loss, abnormal pups, body weight.

GROSS EXAMINATION OF DEAD PUPS:
no
Postmortem examinations (parental animals):
SACRIFICE
- Male animals: Animals were euthanased when found to be moribund or when the adequate number oflitters according to guideline OECD 421 was reached.

- Maternal animals: Dams with offspring were sacrificed on Day 4 post-partum or shortly thereafter.

GROSS NECROPSY
- Gross necropsy consisted of: external and internal examinations including the cervical, thoracic, and abdominal viscera. Special attention was paid to the organs of the reproductive system.

HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were prepared for microscopic examination and weighed, respectively: Epididymides, ovaries, testes and organs with macroscopic alterations. Additional findings in non-protocol organs present on slides were only recorded, if they were of pathological significance.
Testes and epididymes of all male adult animals were weighed. The ovaries, testes, epididymes, accessory sex organs and all other organs showing macroscopic lesions of all adult animals were preserved.
Statistics:
The arithmetic mean, standard deviation and median were calculated for all grouped numerical data originating from the monitoring of body mass and gross pathology (organ mass). In addition, the statistical software Graph Pad Prism for Mac, Version 5.01c. was used to calculate detailed column statistics (minimum/maximum data, 75% percentiles, std error, upper and lower confidence interval 95%). The study director pre-selected data sets of the ranked or incidental data for further analysis to those showing at least few alterations. Most statistical hypotheses in this study are characterised best as “many to one”– a vehicle control vs. three treatment groups. Therefore, the adequate analysis method is a One-Way ANOVA (Analysis of variance), followed by a post hoc t-test. With interval-scaled data, the One-Way ANOVA was supplemented by Dunnett’s post-hoc t-test. In case a Bartlett’s test for equal variances indicated that a data set may be heteroscedastic, it was analysed additionally by the Kruskal-Wallis test (rank transformation) and Dunn’s post-hoc t-test. However, the Study Director decided whether the additional test was necessary – data sets of single parameters were assessed as a whole, indications for heteroscedastic data subsets were disregarded. Ordinal-scaled data would have been analysed by the Kruskal-Wallis test, supplemented by Dunn’s t-test. The entire deductive statistics were performed using Graph Pad Prism. The significance level was set to 0.05.
Reproductive indices:
- Pre-implantation loss: corpora lutea - implantations
- Pre-natal loss: implantations - live births
Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
all test groups: laboured breathing and wheezing breath sounds; 7 animals died due to test item reaching the respiratory tract, 1 animal died due to an application error
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
male high dose group: reduced mean body weight and reduced relative body weight gain; females high dose group: reduced relative body weight gain
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
male high dose group: reduced mean body weight and reduced relative body weight gain; females high dose group: reduced relative body weight gain
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Reproductive function: oestrous cycle:
not examined
Reproductive function: sperm measures:
not examined
Reproductive performance:
effects observed, treatment-related
Description (incidence and severity):
high dose group: mean numbers per dam of corpora lutea slightly and statistically significantly reduced; medium and high dose: weak evidence for a delayed conception
CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS)
Laboured breathing and vocalisations, in animals from all groups treated with test item probably due to the high surface activity of the test item, small amounts of test item solution reached the respiratory tract, some leading to fatalities by acute exogenous lipid pneumonia. Eight animals died spontaneously or were killed during the course of the study. Their premature death of most of these animals is considered to be most likely due to an inadvertent deposition of a small amount of the test item at the laryngeal orifice that was inhaled during inspiration. One rat was euthanised due to an application error.

BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
In high dose males, body weight and relative body weight gain were prominently reduced throughout the entire in-life phase with a net mean body mass loss in the first two weeks of application. Females were less affected during pre-mating, and the effect was even less pronounced during the following weeks. The observed tendency of a lowered relative body weight gain in females of the high dose group during gestation and lactation reached the level of statistical significance in data from the day of birth.
A reduction of the mean relative food consumption as well as a strong increase of mean relative water consumption of males and females from the high dose groups was observed during the first two weeks of application (pre-mating). During the following weeks, mean relative food consumption was mildly (sires) or only in parts (dams Day 14, Day 20 of gestation, Day 0 of lactation) affected. However, the mean relative water consumption of males remained prominently raised.

REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
In the high dose group, the mean numbers per dam of corpora lutea were slightly and statistically significantly reduced. In the medium and high dose group a weak evidence for a delayed conception was apparent.

ORGAN WEIGHTS (PARENTAL ANIMALS)
The organ mass gave no evidence for toxicological effects of the test item on the sexual organs of Wistar rats.

GROSS PATHOLOGY (PARENTAL ANIMALS)
At gross necropsy, no abnormalities were found that could be related to the administration of the test item.

HISTOPATHOLOGY (PARENTAL ANIMALS)
The histomorphological examination of selected rat organs of the male and female genital system (24 males and 24 females) did not reveal morphological lesions related to the test item.


Dose descriptor:
LOEL
Remarks:
reproduction
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: see 'Remark'
Dose descriptor:
NOAEL
Remarks:
reproduction
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: observed effects were considered secondary effects due to parental toxicity
Dose descriptor:
NOAEL
Remarks:
systemic
Effect level:
250 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: reduction of mean relative food consumption and strong increase of mean relative water consumption, reduced mean body weight and body weight gain
Clinical signs:
no effects observed
Mortality / viability:
mortality observed, treatment-related
Description (incidence and severity):
high dose group: significantly raised post natal loss, reduced mean numbers of live pups
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
reduction of body mass with increasing dosage and a statistically highly significant reduction of mean pup body mass and mean litter mass in the high dose group at day four of lactation
Sexual maturation:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Histopathological findings:
not examined
VIABILITY (OFFSPRING)
In the high dose group significantly reduced mean numbers of live pups at Day 4 were observed. Data of the numbers of abnormal pups born, or the loss of offspring (pre-implantation and pre-natal) were normal for rats of this strain and age. In conclusion, post-natal loss was significantly raised in the high dose group.

BODY WEIGHT (OFFSPRING)
A tendency of a reduction of body mass for both genders with increasing dosage and a statistically highly significant reduction of mean pup body mass and mean litter mass in the high dose group at day four was apparent. A mild and statistically significant reduction of male mean pup body mass was found at day of birth in the high dose group when compared to the vehicle control.
Dose descriptor:
NOAEL
Remarks:
reproduction
Generation:
F1
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: observed effects are considered to be secondary effects due to parental toxicity
Dose descriptor:
LOAEL
Remarks:
reproduction
Generation:
F1
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: observed effects are considered to be secondary effects due to parental toxicity
Reproductive effects observed:
not specified

Table 1. Summarised results of the study.

OBSERVATIONS

Dosage (units)

 

 

Vehicle

 

 

Low dose

 

 

Medium dose

 

 

High dose

Pairs started

11*

11#

11#

11#

Totals after first and second mating

Females achieving pregnancy

10

8

9

11

Conceiving Days

1 - 5

10

8

6##

10

Conceiving days 6

0

0

1##

1

Pregnancy = 21 days

0

0

0##

0

Pregnancy = 22 days

8

4

5##

10

Pregnancy ≥ 23 days

2

4

2##

1

Dams with live young born

10

8

9

11

Dams with live young at Day 4 pp

10

8

8

11

Corpora lutea / dam (mean)

16,3

14,1

16,3

12,6

Implantations / dam (mean) 

12,6

9,4

12,6

11,5

Live pups / dam at birth (mean) 

10,7

7,9

9,6

9,6

Live pups / dam at day 4 (mean) 

10,1

6,9

8,9**

5,0

Litter mass Day 0 

64,8

50,3

59,8

48,9

Litter mass Day 4

92,6

67,8

91,4

42,2

No of pups

Live pups born Day 0 (count)

107

63

86

106

Stillborn (count) 

3

3

11

2

Total of pups born Day 0 (count) 

110

66

97

109

Stillborns / pups total (%)

2.8

4.8

12.8

2.8

Sex ratio

Sex ratio d0 (total numbers M / F

54 / 56

33 / 33

49 / 48

54 / 55

Sex ratio d0 (mean, M / F) 

1

1

1

1

Sex ratio d4 (total numbers M / F

56 / 45

31 / 24

38 / 33 **

30 / 25

Sex ratio d4 (mean, M / F) 

1.2

1.3

1.2

1.2

Body mass pups (g)

 

Male pups Day 0 (mean) 

6,1

 

6,3

5,8

5,2

Female pups Day 0 (mean) 

5,8

6,1

5,5

4,9

Male pups Day 4 (mean) 

9,6

10,3

9,6

7,7

Female pups Day 4 (mean) 

9,1

10,0

8,9

7,3

Abnormal pups 

 

 

 

 

Dams with 0 

10

8

9

11

Dams with 1 

0

0

0

0

Dams with ≥ 2 

0

0

0

0

Loss of offspring 

Pre-implantation (corpora lutea minus implant)        

Dams with pre-implantation loss (count) 

10

8

9

11

Pre-implantation loss (mean/group) 

3,7

4,8

3,9

2,4

Pre-natal (implantations minus live births) 

Dams with pre-natal loss (count) 

10

8

9

11

Pre-natal loss (mean/group) 

1,9

1,5

2,9

1,8

Post-natal (live births minus alive at post natal day 4)        

Dams with post-natal loss (count) 

10

8

9

11

Post-natal loss (mean pups/group) 

0.6

1.0

0.7

4.6

* female E112 invalidated

# one female each died within pre-mating phase;

## not reflecting data of two dams (no sperm plug found during mating phase, but pregnancy achieved)

** not reflecting litter mass data of one dam (E135) at Day 4 (data point lost)

Conclusions:
No effect on reproductive performance were observed.
Executive summary:

Considering the fact that no abnormalities were found by a gross necropsy and in the following histopathological examination of the reproductive organs, the authors concluded that the negative effects of the high-dose of the test item on Wistar rat reproduction were not caused by its toxic properties on those organs directly, but rather on other secondary local or systemic factors affecting parental animal health.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 2, due to read across) from a reference substance with similar structure and intrinsic properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There is no data available on the toxicity to reproduction of Reaction products of oleoyl sarcosine with sodium hydroxide. In order to fulfil the standard information requirements set out in Annex VIII, 8.7.1. and IX, 8.7.3. and in accordance with Annex XI, 1.5. of Regulation (EC) No 1907/2006, read-across from a structurally related substance was performed.

In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5. of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, the substances listed below are selected as basis for hazard assessment.

Discussion

No studies are available investigating the toxicity to reproduction of Reaction products of oleoyl sarcosine with sodium hydroxide. In order to fulfil the standard information requirements set out in Annex VIII, 8.7.1. and IX, 8.7.3. and in accordance with Annex XI, 1.5. of Regulation (EC) No 1907/2006, read-across from the structurally related category members (Z)-N-methyl-N-(1-oxo-9-octadecenyl) glycine (CAS 110-25-8) and Sodium N-lauroylsarcosinate (CAS 137-16-6) was conducted.

(Z)-N-methyl-N-(1-oxo-9-octadecenyl) glycine (CAS 110-25-8) was tested for toxicity to reproduction in a 28-day screening study according to OECD guideline 421 under GLP conditions (Stein, 2010). The doses were based on the results of a 28-day dose range finding study, with 3 animals per dose and sex orally exposed to 50, 250 and 1000 mg/kg bw/day. In the main study, groups of 12 Wistar rats (m, f) were given 50, 250 and 1000 mg/kg bw/day of the test material by gavage. Male animals were treated with the test material two weeks before mating, throughout the mating period and until the study was terminated. The female animals were exposed for 2 weeks before mating, up to 14 days until mating, for an average of 21 days of gestation, and a minimum of 4 days of lactation. A concurrent negative control group receiving the vehicle only (1% sodium carboxymethyl cellulose + 0.1% Polysorbate 80 (Tween 80), diluted in water) was included in the testing as well.

Examination of the parental animals revealed laboured breathing and vocalisations in animals from all groups treated with test item, probably due to the high surface activity of the test item. Small amounts of test item solution reached the respiratory tract, some leading to fatalities by acute exogenous lipid pneumonia. Eight animals died spontaneously or were killed during the course of the study. The premature death of most of these animals is considered to be most likely due to an inadvertent deposition of a small amount of the test item at the laryngeal orifice that was inhaled during respiration. One rat was euthanised due to an application error. In high dose males, body weight and relative body weight gain were prominently reduced throughout the study with a net mean body mass loss in the first two weeks of application. In females of the high dose group, a significantly lowered relative body weight gain during gestation and lactation was observed. However, the decreased body weights are considered to be a secondary effect due to the reduction in the mean relative food consumption and an increase in the mean relative water consumption observed in all animals from the high dose groups during the first two weeks of application. No effects on the organ mass of the sexual organs and no histomorphological effects on the genital system were observed. In addition, no test item related abnormalities were found during gross necropsy.

Regarding the reproductive performance, animals of the high dose groups showed a slightly but statistically significantly reduced mean number per dam of corpora lutea. Furthermore, in the medium and high dose group a weak evidence for a delayed conception was apparent. In the high dose group significantly reduced mean numbers of live pups at Day 4 were observed. However, the numbers of abnormal pups born and the pre-implantation and pre-natal loss were normal for rats of this strain and age, indicating that the post-natal loss was significantly raised in the high dose group. A statistically highly significant reduction of mean pup body mass and mean litter mass in the high dose group at day four was apparent. A mild and statistically significant reduced mean pup body mass (males) was found at day of birth in the high dose group when compared to the vehicle control as well. Considering the fact that no abnormalities were found by a gross necropsy and in the following histopathological examination of the reproductive organs of the parental animals, the authors concluded that the negative effects of the high dose of the test item on reproduction were not caused by its toxic properties on those organs directly, but rather on other secondary local or systemic factors affecting parental animal health, for example reduced food intake during pregnancy. Thus, a systemic NOAEL for the parental animals (m, f) of 250 mg/kg bw/day and a NOAEL (m, f) for reproduction of 1000 mg/kg bw/day was evaluated in the study.

In addition, data is available from a 2-year study with 200 rats treated with Sodium N-lauroylsarcosinate (CAS 137-16-6), that included a fertility assessment (CIR, 2001; Technology Science Group Inc., 1994). Groups of 25 Wistar rats per sex and dose were given 0.05, 0.2 and 1% of the test material in the diet, 7 days/week for 24 months. The concentration of the test material in the low dose group was increased to 2% (equiv. to 1000 mg/kg bw/day) after 6 months. A concurrent negative control group receiving the plain diet was included. At one, three and six months no significant differences were observed in mortality, body weight gain and haematology. At the end of the study period, the only consistent difference observed in gross pathology was minor hyperplasia of the stratified squamous epithelium with excess keratin formation of the cardiac mucosa of the stomach in rats receiving the highest dose of the test article (group 1: 2%; group 3: 1% in the diet). No details of the fertility assessment were given; however the authors reported that the test material did not show any significant effects on reproductive function of the parental animals.

In summary, both studies with the category members (Z)-N-methyl-N-(1-oxo-9-octadecenyl) glycine (CAS 110-25-8) and Sodium N-lauroylsarcosinate (CAS 137-16-6) showed no effects on reproductive performance, and a NOAEL for reproductive toxicity of 1000 mg/kg bw/day was defined.

Conclusion for toxicity to reproduction

In summary, both studies for the category members with the longest and the shortest carbon chain length, one of them representing the acid form, the other one representing the sodium salts, (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8)  and Sodium N-lauroylsarcosinate (CAS 137-16-6), respectively, showed no effects on reproductive performance, and a NOAEL for reproductive toxicity of 1000 mg/kg bw/day was adopted for the Sarcosine category.


Short description of key information:
Toxicity to reproduction: NOAEL 1000 mg/kg bw/day (OECD 421), based on read-across

Justification for selection of Effect on fertility via oral route:
Hazard assessment is conducted by means of read-across based on a category approach. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties among the category members and overall assessment of quality, duration and dose descriptor level (refer to the endpoint discussion for further details).

Effects on developmental toxicity

Description of key information
Data waiving: study with structurally related substance proposed which will be used for read-across
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

A prenatal developmental toxicity study according to OECD Guideline 414 with the structurally related substance Sodium N-lauroylsarcosinate (CAS 137-16-6) via the oral route in rodents is proposed by the respective Lead Registrant, and the generated data will comply with the criteria for read-across according to Regulation (EC) No 1907/2006, Annex XI, article 1.5.


Justification for selection of Effect on developmental toxicity: via oral route:
A prenatal developmental toxicity study according to OECD Guideline 414 with the structurally related substance Sodium N-lauroylsarcosinate (CAS 137-16-6) via the oral route in rodents is proposed by the respective Lead Registrant, and the generated data will comply with the criteria for read-across according to Regulation (EC) No 1907/2006, Annex XI, article 1.5.

Justification for classification or non-classification

The available data on toxicity to reproduction of substances structurally related to Reaction products of oleoyl sarcosine with sodium hydroxide do not meet the criteria for classification according to Regulation (EC) No 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

Additional information