Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No experimental data are available for the target substance Undecylenamidopropyl Betaine. However, reliable data from a 28 d repeated dose toxicity study in rats with additional focus on reproductive organs is available for the source substance C8-10 Alkylamidopropyl betaine. Further repeated dose toxicity studies are available for the closely related source substances C8-18 AAPB, C8-18 and C18 unsatd. AAPB and Formamidopropylbetaine. A justification for read-across is given below.

 

In accordance with Annex VIII column 2 of the REACH Regulation (EC) No 1907/2006, the performance of a reproductive toxicity screening study is not required. Pre-natal developmental toxicity studies (Annex IX, 8.7.2) are available from closely related source substances.

Moreover, there was no indication of any systemic toxicity relevant in view of a potential health risk for humans in the sub-chronic studies conducted with closely related source substances, including reproductive organs.

 

In a subacute toxicity study according to OECD guideline 407 (2008) and EU method B.7 (2008) C8-10 Alkylamidopropyl betaine (34.65% a.i.) was administered to 5Hsd: Sprague Dawley SD rats/sex/dose in purified water by gavage at dose levels of 0 (control), 100, 300 and 500 mg/kg bw/day for 28 consecutive days. Control and high dose groups included 5 additional animals per sex to be sacrificed after 2 weeks of recovery.

No mortality occurred. No clinical signs and no changes were observed at the weekly detailed clinical observations. Neurotoxicity assessment did not reveal any treatment-related effects. No changes on body weight and food consumption were noted.

The lymphocytosis and monocytosis seen in single females dosed at 300 and/or 500 mg/kg bw/day showed reversibility at the end of the recovery period or comparability to control data. No toxicological relevant effects in coagulation and clinical chemistry parameters were observed. No differences were reported in terminal body weights and organ weights between treated and control animals and no treatment-related changes were noted at macroscopic and microscopic observations.

Seminiferous tubules were evaluated with respect to their stage in the spermatogenic cycle and to the integrity of the various cell types within the different stages; regular layering in the germinal epithelium was noted.

Normal physiology of the oestrous cycle (oestrous, metestrous, diestrous and proestrous) was noted in control and treated females. The morphological changes seen were normal when compared to each “oestrous phase” in the ovaries, uterus/cervix and vagina.

On the basis of the results obtained in this study, the dose level of 500 mg/kg bw/day was considered the NOAEL.

 

In the 90-day repeated dose toxicity studies (tested doses up to and including approx. 300 mg a.i./kg bw/d) in rats conducted with C8-18 AAPB or C8-18 and C18 unsatd. AAPB, there were no histopathological changes in reproductive organs (seminal vesicles, prostate, epididymides, testes, mammary glands, ovaries and fallopian tubes, uterus, cervix, vagina) and no effects on reproductive organs weights (testes, ovaries). In the prenatal developmental toxicity study C8-18 AAPB showed no teratogenic activity, and embryotoxic effects were found only at the maternal toxic dose level. Taking into account the overall low toxic activity of the substances, particularly with regard to the missing adverse effects on reproductive organs or tissues in the repeated dose toxicity studies as well as in the developmental toxicity study, the missing teratogenic activity, the fact that embryotoxic effects were found only at the maternal toxic dose level and the toxicodynamics of both substances, which is primarily based on its irritancy, fertility-specific effects are highly unlikely to occur. Therefore, further reproductive toxicity studies do not need to be conducted.

 

In a subchronic toxicity study (according to OECD Guideline 408), Formamidopropylbetaine was administered to 10 Wistar rats/sex/dose by gavage at dose levels of 0, 100, 300 and 1000 mg/kg for 90 consecutive days.

There were no compound related effects in mortality, clinical signs, functional observations, ophthalmoscopy, body weight and weight gain, food consumption and food efficiency, hematology, clinical chemistry, organ weights, gross and histologic pathology or neurobehaviour.

Especially no effects on the weights on reproductive organs (testes, epididymides, prostate, seminal vesicles including coagulating glands, uterus, ovaries) were noted. Histopathological examination revealed no microscopic findings in the reproductive organs (testes, epididymides, prostate, seminal vesicles, uterus, ovaries, cervix, vagina).

From the results presented in this report a No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg bw/d was established.

 

There are no data gaps for effects on fertility. No human data are available. However, there is no reason to believe that these results from rat would not be applicable to humans.

 

Conclusion

The NOEL for effects on fertility is derived from the 90 d repeated dose toxicity study with additional focus on reproductive organs, which was conducted with C8-18 AAPB which is the highest tested dose of 300 mg a.i./kg bw/day.

 

There are no data gaps for the endpoint fertility. No human data are available. However, there is no reason to believe that these results from rat would not be applicable to humans.

 

Justification for read-across

For details on substance identity and detailed toxicological profiles, please refer also to the general justification for read-across given at the beginning of the CSR and attached as pdf document to IUCLID section 13.

 

This read-across approach is justified based on structural similarities. The target and source substances contain the same functional groups. Thus a common mode of action can be assumed.

The only deviation within this group of substances is a variety in their carbon chain length, which obviously does not have a relevant impact on toxicity to reproduction as demonstrated by the available data on the source substances.

 

a. Structural similarity and functional groups

 

The target substance Undecylenamidopropyl Betaine is a monoconstituent substance manufactured from undecylenic acid and N, N-dimethylpropylenediamine (DMAPA) and further reacted with monochloroacetic acid.

 

The source substance C8-10 Alkylamidopropyl betaine is a UVCB substance manufactured from fatty acids (C8 and C10) and N, N-dimethylpropylenediamine (DMAPA)and further reacted with sodium monochloroacetate.

The source substance C8-18 AAPB is a UVCB substance manufactured from natural fatty acids or oils with N, N-dimethylpropylenediamine (DMAPA) and further reacted with sodium monochloroacetate. As their origin is from natural sources, the used fatty acids may have a mixed slightly varying composition with an even numbered chain length from C8 to C18. Unsaturated C18 amounts may be included.

The source substance C8-18 and C18 unsatd. AAPB is a UVCB substance manufactured from natural fatty acids or oils with N, N-dimethylpropylenediamine (DMAPA) and further reacted with sodium monochloroacetate. As their origin is from natural sources, the used fatty acids may have a mixed slightly varying composition with an even numbered chain length from C8 to C18. Unsaturated C18 amounts may be included.

 

The source substance Formamidopropylbetaine is a monoconstituent substance manufactured from formic acid and N, N-dimethylpropylenediamine (DMAPA) and further reacted with sodium monochloroacetate.

 

b. Differences

Differences in chemical and other intrinsic properties of the target and source substances could potentially arise from the following facts:

-Different amounts of different carbon chain lengths (carbon chain length distribution):

Higher amounts of higher chain lengths and corresponding lower amounts of lower chain length lead to a rising average lipophilicity as can be seen from the increasing log Kow from Formamidopropylbetain (log Kow: -3.3), Undecylenamidopropyl Betaine (log Kow: -1.38), C8-10 Alkylamidopropyl betaine (log Kow: 2.2), C12 AAPB (log Kow: 3.54), C8-18 AAPB (log Kow: 4.23).

There are clear trends in the physicochemical properties (with regard molecular weight, water solubility, log Kow and surface tension) as demonstrated in detail in the general justification for read-across. As data on developmental toxicity are available for the upper and lower end of this row similarly showing the absence of toxicity to reproduction, the differences in C chain lengths obviously do not influence the intrinsic toxicity. 

- Different amounts of unsaturated fatty ester moieties:

The source substance C8-18 and C18 unsatd. AAPB contains considerable amounts of unsaturated C18 chains, which represents a worst case with respect tosome toxicological endpoints, mainly local effects (e.g. irritation, sensitisation). But in general, variability in the fatty acid moiety is not expected to be relevant to the intrinsic systemic or reproductive toxicity of the substances.

 

The provided structural similarities and impurity profiles support the proposed read-across hypothesis with high confidence.

 

Comparison of reproductive toxicity data

Endpoints

Source substances

Target substance

 

C8-18 and C18 unsatd. AAPB

C8-18 AAPB

Formamido-propylbetaine

C8-10 Alkylamidopropyl betaine

Undecylenamidopropyl Betaine

Data from tepeated dose toxicity studies

sup_RA_Toxicity to reproduction: 61789-40-0_8.6.2_90days_Unilever_A03_FT890785

 

Key study

 

OECD TG 408, subchronic, rat, oral: feed

 

NOEL effects relevant to humans: 247 mg a.i./kg bw/d (highest tested dose, 1 % in feed, 731 mg/kg bw/d based on product (a.i. 33.8 %))

 

LOEL: 97 mg a.i./kg bw/day) (0.4% in feed, 288 mg/kg bw/d based on product (a.i. 33.8 %))

 

Reliability: 1 (reliable without restriction), GLP

sup_RA_Toxicity to reproduction: 97862-59-4_8.6.2_Goldschmidt_1991_OECD 408
key study


OECD TG 408, subchronic, rat, oral: gavage


NOEL systemic effects: 300 mg a.i./kg bw/d (highest tested dose, 1000 mg/kg bw/d based on product (a.i. ca. 30 %))


LOEL local effects: 150 mg a.i./kg bw/d (500 mg/kg bw/d based on product (a.i. ca. 30 %))


NOEL local effects: 75 mg a.i./kg bw/d (250 mg/kg bw/d based on product (a.i. ca. 30 %))

 

Reliability: 1 (reliable without restriction), GLP

sup_RA_Toxicity to reproduction: oral 90-day OECD 408 NOTOX 497622

 

OECD TG 408, subchronic, rat, oral: gavage

 

NOAEL = 1000 mg/kg bw/d

No toxicologically relevant effects were observed up to the highest dose level tested.

 

Reliability: 1 (reliable without restrictions), GLP

sup_RA_Toxicity to reproduction: 73772-45-9 / 73772-46-0_8.6.2_Evonik_2016_OECD407

 

OECD TG 407, subacute, rat, oral: gavage

 

NOAEL = 500 mg/kg bw/d

No toxicologically relevant effects were observed up to the highest dose level tested

 

Reliability: 1 (reliable without restrictions), GLP

No data, read-across

Prenatal developmental toxicity

No data

WoE_Developmental toxicity / teratogenicity: 97862-59-4_8.7.2_CESIO_2004_OECD 414

Key study

OECD TG 414, rat, oral: gavage

NOEL maternal toxicity: 100 mg a.i./kg bw/day
NOEL embryotoxicity: 300 mg a.i./kg bw/day
NOEL teratogenicity: 1000 mg a.i./kg bw/day
Maternal toxic effects: yes
Embryotoxic / teratogenic effects: yes

 

Reliability: 1 (reliable without restriction), GLP

WoE_RA_Developmental toxicity / teratogenicity NOTOX 497620

 

OECD TG 414, rat, oral: gavage

 

NOEL maternal toxicity: 1000 mg a.i./kg bw/day
NOEL teratogenicity: 1000 mg a.i./kg bw/day

 

Maternal toxic effects: no
Embryotoxic / teratogenic effects: no

 

Reliability: 1 (reliable without restrictions), GLP

No data

No data, read-across

 

In the repeated dose toxicity studies performed according to the corresponding OECD Guidelines on the source substances C8-10 Alkylamidopropyl betaine, C8-18 AAPB, C8-18 and C18 unsatd AAPB and Formamidopropylbetaine, up to and including the respective highest tested dose levels, no indication of any effects of the substances to reproductive organs were observed.

In the prenatal developmental toxicity study (tested doses up to and including 1000 mg a.i./kg bw/d) C8-18 AAPB showed no teratogenic activity, and embryotoxic effects were found only at the maternal toxic dose level. The second source substance Formamidopropylbetaine showed no teratogenic or embryotoxic activity

 

Quality of the experimental data of the analogues:

The available data are adequate and sufficiently reliable to justify the read-across approach.

Repeated dose toxicity studies:

The studies were conducted according to OECD Guideline 407 or 408 and were reliable without restrictions (RL1, GLP).

Prenatal developmental toxicity studies:

The studies were conducted according to OECD Guideline 414 and reliable without restrictions (RL1, GLP).

 

The test materials used in the respective studies represent the source substance as described in the hypothesis in terms of substance identity and minor constituents.

Overall, the study results are adequate for the purpose of classification and labelling and risk assessment.

 

Conclusion

Based on structural similarities of the target and source substancesas presented above and in more detail in the general justification for read across, it can be concluded that the available data from the source substances C8-10 Alkylamidopropyl betaine, C8-18 AAPB, C8-18 and C18 unsatd. AAPB and Formamidopropylbetaine are also valid for the target substance Undecylenamidopropyl Betaine .

 

In the subacute repeated dose toxicity study in rats conducted with the source substance C8-10 Alkylamidopropyl betaine, there were no histopathological changes in reproductive organs (epididymides, seminal vesicles, prostate + coagulating glands, testes, ovaries + oviduct, uterus, cervix, vagina) and no effects on reproductive organs weights (epididymides, testes, prostate, ovaries). Spermatogenic staging and oestrous cycle were normal.

In the repeated dose toxicity studies in rats conducted with C8-18 and C18 unsatd. AAPB and C8-18 AAPB, there were no histopathological changes in reproductive organs (seminal vesicles, prostate, epididymides, testes, mammary glands, ovaries and fallopian tubes, uterus, cervix, vagina) and no effects on reproductive organs weights (testes, ovaries).

In the subchronic toxicity study in rat conducted with the source substance Formamidopropylbetaine no effects on the weights on reproductive organs (testes, epididymides, prostate, seminal vesicles including coagulating glands, uterus, ovaries) were noted. Histopathological examination revealed no microscopic findings in the reproductive organs (testes, epididymides, prostate, seminal vesicles, uterus, ovaries, cervix, vagina).

Taking into account the overall low toxic activity of the substances, particularly with regard to the missing adverse effects on reproductive organs or tissues in the 28 day and 90 day studies as well as in the developmental toxicity studies, the missing teratogenic activity, the fact that embryotoxic effects – if at all – were found only at the maternal toxic dose level, fertility-specific effects are highly unlikely. 


Short description of key information:
- subacute (28 d) repeated dose toxicity study with additional focus on reproductive organs, oral (gavage), Sprague-Dawley rat, m/f; OECD TG 407; GLP; RL1, dose levels: 0, 100, 300, 500 mg a.i./kg bw/d; NOAEL = 500 mg a.i./kg bw/d; read-across: C8-10 Alkylamidopropyl betaine
- subchronic (90 d) repeated dose toxicity study with additional focus on reproductive organs, oral (gavage), Sprague-Dawley rat, m/f; OECD TG 408; GLP; RL1, dose levels: 0, 75, 150, 300 mg a.i./kg bw/d; NOEL = 300 mg a.i./kg bw/d; read-across: C8-18 AAPB
- subchronic (90 d) repeated dose toxicity study with additional focus on reproductive organs, oral (diet), Wistar rat, m/f; OECD TG 408; GLP; RL1, dose levels: 0, 9.5, 24, 97 and 247 mg a.i./kg bw/day/d; NOEL = 247 mg a.i./kg bw/d; read-across: C8-18 and C18 unsatd. AAPB (Coco AAPB)
- subchronic (90 d) repeated dose toxicity study with additional focus on reproductive organs, oral (gavage), Wistar rat, m/f; OECD TG 408; GLP; RL1, dose levels: 0, 100, 300, 1000 mg a.i./kg bw/day; NOAEL = 1000 mg a.i./kg bw/d; read-across: Formamidopropylbetaine

Justification for selection of Effect on fertility via oral route:
no single study has been selected as key study, since all available data are considered together

Effects on developmental toxicity

Description of key information
- Prenatal developmental toxicity study; oral (gavage); rat (CD/Crl:CD, 25/group, dosed from day 5 through 19 post coitum); OECD Guideline 414; GLP; RL1; NOEL(maternal toxicity) = 100 mg/kg bw/d / NOEL(embryotoxicity) = 300 mg/kg bw/d / NOEL(teratogenicity) = 1000 mg/kg bw/d, read-across: C8-18 AAPB.
- Prenatal developmental toxicity study; oral (gavage); rat (Wistar, 22/group, dosed from day 6 through 19 post coitum); OECD Guideline 414; GLP; RL1; NOEL(maternal toxicity, embryotoxicity, teratogenicity) = 1000 mg/kg bw/d, read-across: Formamidopropylbetaine
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
rat
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

No experimental data are available for the target substance Undecylenamidopropyl Betaine. However, reliable and relevant data are available for the closely related source substances C8-18 AAPB and Formamidopropylbetaine. A justification for read-across is given below.

 

In a prenatal developmental toxicity study performed according OECD 414, C8-18 AAPB (28.9% a.i, 62% water, and 5.4% NaCl) was administered to 25 females CD rats/dose at dose levels of 0, 330, 990, 3300 mg from day 5 through 19 of gestation by gavage. The test item dose levels refer to nominal active ingredient of 100, 300, and 1000 mg/kg bw/day. The nominal values were analytically verified in samples taken at study initiation and study termination. The actual concentrations of the samples taken from the aqueous test item carrier mixtures were within the range of 101.9 % to 109.9 % of the nominal C8-18 AAPB concentrations indicating correctly prepared application mixtures and a sufficient stability. Number of evaluated pregnant rats were 20/group (the first 20 animals with pregnancy signs were used). Animals evaluated for maternal toxicity were 20/group except of high dose group in which one additional animal was included due to a premature death of one dam.

Regarding maternal toxicity, the dams of the 990 mg/kg bw/day group showed decreased net body weight change from day 6 onward (= carcass weight minus day 6 body weight), reduced food consumption, thickened/partly thickened stomach mucosa in 4 of 20 animals and in addition ulcers (diameter approximately 1 mm or 0.5 to 1 mm) in 2/4 animals with thickened mucosa. In the 3300 mg/kg bw/day group the dams showed severely reduced food consumption, reduced body weights (absolute, body weight gain on gestation days 3 to 6, 6 to 9, 12 to 15, 15 to 18 and 18 to 20, and net body weight change from day 6 onward), reduced carcass weight and reduced gravid uterus weights. Thickened or partly thickened stomach mucosa (greyish discoloured in two dams) was noted in 20 of 21 dams including one prematurely deceased dam. In addition, in two of these dams a few ulcers were noted in the stomach (diameter up to 1 mm).

The number of early, late and total resorptions was increased in the 3300 mg/kg bw/day group, and the ratio of viable fetuses to implantation sites was decreased compared to the controls. This was due to a total post-implantation loss in two dams in this dose group. In addition, a statistically significant reduction in fetal weights and in the number of viable fetuses as compared to the control was observed. No external, skeletal or soft tissue malformations and no external variations were found.

The NOEL for maternal toxicity was 330 mg/kg bw/day (corresponding to 100 mg active ingredient/kg bw/day).

The NOEL for developmental toxicity was 990 mg/kg bw/day (corresponding to 300 mg active ingredient/kg bw/day).

The NOEL for external, skeletal or soft tissue malformations and variations was the highest tested dose of 3300 mg/kb bw/day (corresponding to the guideline limit dose of 1000 mg active ingredient/kg bw/day.

 

In a developmental toxicity study according to OECD guideline 414, Formamidopropylbetaine was administered to 22 female Crl:WI(Han) rats/dose by gavage at dose levels of 0, 100, 3000 and 1000 mg/kg bw/day from days 6 to 19 post-coitum.

There were no maternal treatment-related effects in mortality, clinical signs, body weight, food consumption, or caesarean parameters observed in the 100, 300 and 1000 mg/kg/day groups. The maternal NOEL is at least 1000 mg/kg bw/day, based on no effects up to the limit dose.

There were no treatment-related effects in developmental parameters observed in the 100, 300 and 1000 mg/kg/day groups. The developmental NOEL is at least 1000 mg/kg bw/day, based on no effects up to the limit dose.

 

Conclusion

The NOEL of 300 mg a.i./kg bw/day for developmental toxicity and embryotoxicity is derived from the prenatal developmental toxicity study conducted with C8-18 AAPB.

 

There are no data gaps for the endpoint developmental toxicity. No human data are available. However, there is no reason to believe that these results from rat would not be applicable to humans.

 

Justification for read-across

For details on substance identity and detailed toxicological profiles, please refer also to the general justification for read-across given at the beginning of the CSR and attached as pdf document to IUCLID section 13.

 

This read-across approach is justified based on structural similarities. The target and source substances contain the same functional groups. Thus a common mode of action can be assumed.

The only deviation within this group of substances is a variety in their carbon chain length, which obviously does not have a relevant impact on developmental toxicity as demonstrated by the available data on the source substances.

 

a. Structural similarity and functional groups

The target substance Undecylenamidopropyl Betaine is a monoconstituent substance manufactured from undecylenic acid and N, N-dimethylpropylenediamine (DMAPA) and further reacted with monochloroacetic acid.

The source substance C8-18 AAPB is a UVCB substance manufactured from natural fatty acids or oils with N, N-dimethylpropylenediamine (DMAPA) and further reacted with sodium monochloroacetate. As their origin is from natural sources, the used fatty acids may have a mixed slightly varying composition with an even numbered chain length from C8 to C18. Unsaturated C18 amounts may be included.

 

The source substance Formamidopropylbetaine is a monoconstituent substance manufactured from formic acid and N, N-dimethylpropylenediamine (DMAPA) and further reacted with sodium monochloroacetate.

 

b. Differences

Differences in chemical and other intrinsic properties of the target and source substances could potentially arise from the following facts:

-Different amounts of different carbon chain lengths (carbon chain length distribution):

Higher amounts of higher chain lengths and corresponding lower amounts of lower chain length lead to a rising average lipophilicity as can be seen from the increasing log Kow from Formamidopropylbetaine (log Kow: -3.3), Undecylenamidopropyl Betaine (log Kow: -1.38), C8-18 AAPB (log Kow: 4.23).

There are clear trends in the physicochemical properties (with regard molecular weight, water solubility, log Kow and surface tension) as demonstrated in detail in the general justification for read-across. As data on developmental toxicity are available for the upper and lower end of this row similarly showing the absence of developmental toxicity, the differences in C chain lengths obviously do not influence the intrinsic toxicity. 

- Different amounts of unsaturated fatty ester moieties:

The target substance Undecylenamidopropyl Betaine contains unsaturated C11 chains, which may be relevant for local effects (e.g. irritation, sensitisation). But in general, variability in the fatty acid moiety is not expected to be relevant to the intrinsic systemic or developmental toxicity of the substances.

 

The provided structural similarities and impurity profiles support the proposed read-across hypothesis with high confidence.

 

Comparison of developmental toxicity data

Endpoints

Source substances

 

Target substance

 

C8-18 AAPB

Formamido-propylbetaine

Undecylenamidopropyl Betaine

Prenatal developmental toxicity

WoE_Developmental toxicity / teratogenicity: 97862-59-4_8.7.2_CESIO_2004_OECD 414

Key study

OECD TG 414, rat, oral: gavage

NOEL maternal toxicity: 100 mg a.i./kg bw/day
NOEL embryotoxicity: 300 mg a.i./kg bw/day
NOEL teratogenicity: 1000 mg a.i./kg bw/day
Maternal toxic effects: yes
Embryotoxic / teratogenic effects: yes

 

Reliability: 1 (reliable without restriction), GLP

WoE_RA_Developmental toxicity / teratogenicity NOTOX 497620

 

OECD TG 414, rat, oral: gavage

 

NOEL maternal toxicity: 1000 mg a.i./kg bw/day
NOEL teratogenicity: 1000 mg a.i./kg bw/day

 

Maternal toxic effects: no
Embryotoxic / teratogenic effects: no

 

Reliability: 1 (reliable without restrictions), GLP

No data, read-across

 

No experimental data are available for the target substance.

In the prenatal developmental toxicity study (tested doses up to and including 1000 mg a.i./kg bw/d) C8-18 AAPB showed no teratogenic activity, and embryotoxic effects were found only at the maternal toxic dose level. Similarly, the second source substance Formamidopropylbetaine showed no teratogenic or embryotoxic activity up to and including the limit dose of 1000 mg/kg bw/d.

 

Quality of the experimental data of the analogues:

The available data are adequate and sufficiently reliable to justify the read-across approach.

The studies were conducted according to OECD Guideline 414 and reliable without restrictions (RL1, GLP).

 

The test materials used in the respective studies represent the source substance as described in the hypothesis in terms of substance identity and minor constituents.

Overall, the study results are adequate for the purpose of classification and labelling and risk assessment.

 

Conclusion

Based on structural similarities of the target and source substances as presented above and in more detail in the general justification for read across, it can be concluded that the available data from the source substances C8 -18 AAPB and Formamidopropylbetaine are also valid for the target substance Undecylenamidopropyl Betaine .

Adequate and reliable scientific information indicates that the source and target substances have similar toxicity profiles: low systemic toxicity, not mutagenic.

As genotoxicity is one possible mechanism for developmental toxicity, the negative outcome of the genotoxicity tests for the target and source substances further supports the read-across (see section "Genotoxicity"). Genotoxicity is based on covalent binding of the substance itself or reactive metabolites to cellular macromolecules as rate determining step. A similar mechanism based on reactive metabolites is involved in sensitisation; target and source substances were not sensitisers (see section "Sensitisation"). Thus, the consistency across these endpoints increases the confidence in the conclusion that there is no concern for reactive metabolites.

Justification for selection of Effect on developmental toxicity: via oral route:
no single study has been selected as key study, since all available data are considered together in a weight of evidence approach

Justification for classification or non-classification

Based on the available data Undecylenamidopropyl Betaine does not need to be classified for toxicity to reproduction, developmental toxicity and teratogenicity according to the criteria given in regulation (EC) 1272/2008. Thus, no labelling is required.