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EC number: 618-295-5 | CAS number: 897626-46-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
The PFAE Linear (Polyfunctional Aliphatic Ester) category consists of 16 substances, well-defined mono-constituent substances as well as related UVCB substances, respectively with varying fatty alcohol chain lengths and branching. The distinguishing feature of this category of chemicals is that they are diester derivatives of common dicarboxylic acids: namely adipic (C6), azelaic (C9) and sebacic (C10) acids. The alcohol portion of the diesters generally falls in the C3-C20 carbon number range, including linear and branched, even and odd numbered alcohols.
In order to avoid the need to test every substance for every endpoint, the category concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13) and within Chapter 5.1 of the CSR.
Endpoint specific data matrix:
ID # |
CAS |
Toxicity to reproduction – Fertility |
1 |
6938-94-9 (a) |
RA: CAS 105-99-7 |
2 |
105-99-7 |
Experimental result: RA: CAS 103-23-1 |
3 |
110-33-8 |
RA: CAS 105-99-7 |
4 |
1330-86-5 |
RA: CAS 105-99-7 |
5 |
123-79-5 (b) |
-- |
6 |
103-23-1 |
NOAEL P (males/females) ≥ 2102/2399 mg/kg bw/day |
7 |
68515-75-3 |
-- |
8 |
33703-08-1 |
-- |
9 |
16958-92-2 |
RA: CAS 103-23-1 |
10 |
85117-94-8 |
-- |
11 |
103-24-2 |
Experimental result: |
12 |
897626-46-9 |
RA: CAS 103-24-2 |
13 |
7491-02-3 |
RA: CAS 103-23-1 |
14 |
109-43-3 |
RA: CAS 103-23-1 |
15 |
122-62-3 |
RA: CAS 103-23-1 |
16 |
69275-01-0 |
-- |
(a) Category members subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.Only for these substances a full set of experimental results and/or read-across is given.
(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
(c) Original data source is not available and thus not used for read-across.
Toxicity to reproduction
Diester of Adipic acid
CAS 105-99-7
An oral gavage reproduction/developmental toxicity screening test with Dibutyl adipate (CAS 105-99-7) was performed in Sprague-Dawley rats according to OECD guideline 421 and under conditions of GLP (Nagao, 1996). Dilutions of the test substance in corn oil were administered once daily to groups of 13 animals per sex at dose levels of 100, 300 and 1000 mg/kg bw/day via gavage. A similar constituted group received the vehicle and acted as control. Females were exposed for a total period of 42-53 days, including 14 days before mating and until Day 3 of lactation, whereas males were treated 14 days before mating and 28 days thereafter. After administration, clinical signs involved a dose-dependent increase in salivation in animals of both sexes. However, the increase in salivation was not regarded as neurological effect, but caused by stimulation by the administration of the test substance. A slight, but non-significant suppression of body weight gain was observed in males at 1000 mg/kg bw/day. The relative organ weight of kidney was statistically significantly increased in both sexes at 1000 mg/kg bw/day. In addition, an increase in the relative weight of spleen in males treated with 100 and 1000 mg/kg bw/day was observed, while the only change in spleen weight noted in females involved the increase in absolute weight at 100 mg/kg bw/day. No effects on reproductive function (sperm parameters and oestrus cyclicity) and performance (copulation, fertility, gestation, implantation and delivery index) were observed after treatment compared to controls in any of the parental animals. Testis weight, epididymis weight, and histology of these organs did not reveal any substance-related effects in males. Effects on offspring included a statistically significant decrease in the pub viability on Day 4 of lactation at the 1000 mg/kg bw/day dose group compared to controls. At the same dose, a slight decrease in pub weight was observed on Day 0 and Day 4 of lactation without reaching statistical significance.
Based on the results of this study, the NOAEL for reproductive toxicity in parental animals was established at
≥
1000 mg/kg bw/day, while the NOAEL for systemic toxicity in parental and F1 animals was set at 300 mg/kg bw/day.
CAS 103-23-1
The toxicity to reproduction of Bis(2-ethylhexyl) adipate (CAS 103-23-1) has been investigated in a one-generation reproduction toxicity study similar to OECD 415.
The effect of Bis(2-ethylhexyl) adipate on the fertility of Alpk:APfSD (Wistar-derived) rats was investigated in a GLP-conform study similar to OECD guideline 415 (Tinston, 1988). Groups of 15 male and 30 female parental animals were exposed daily to the test substance at dietary concentrations of 300, 1800 or 12000 ppm, corresponding to mean achieved dose levels of 52, 178 and 2102 mg/kg bw/day for males and 61, 203 and 2399 mg/kg bw/day for females, respectively. A similar constituted group of animals received the plain diet and served as controls. After 10 weeks of treatment the animals were mated to produce a single litter (F1), which were reared until Day 36 post partum. Male parents were killed after completion of mating and female parents were killed after weaning their litter. There was no evidence for any clear effect on bodyweight or food consumption during the premating phase of the study apart a marginal reduction in bodyweight gain for female rats in the 12000 ppm test group. This decrease in body weight continued through gestation in the female animals of the highest dose group compared to controls. There were no treatment-related effects on pre-coital interval, length of gestation, or on male and female fertility. Offspring weight gain, total litter weight and litter size in the 12000 ppm test group were reduced compared to controls, but there was no effect on the number of pups born live or on their survival at any dose level of the test substance. An increase in absolute and relative liver weight was observed in both male and female parents receiving dietary levels of 12000 ppm. No treatment-related findings were observed at gross pathology, except for accentuated lobular pattern in the liver of two female rats fed diets containing 12000 ppm of the test substance. No histological changes were noted in the reproductive organs of those males and females which failed to breed and were thus suspected of being infertile. Based on the results of this study the NOAEL for fertility was set at >= 12000 ppm in the diet, which corresponded to mean achieved dose levels of 2102 and 2399 mg/kg bw/day in males and females, respectively. The NOAEL for systemic toxicity for parental animals (P) and offspring (F1) was considered to be at 1800 ppm, equivalent to dose levels of 178 and 203 mg/kg bw/day in males and females, respectively.
In summary, the NOAEL for fertility from the one-generation reproduction toxicity study of Bis(2-ethylhexyl) adipate was set at
≥
12000 ppm in the diet, which corresponded to mean achieved dose levels of ≥ 2102 and≥
2399 mg/kg bw/day in males and females, respectively.
Diester of Azelaic acid
CAS 103-24-2
One GLP-conform reprotoxicity screening study according to OECD 422 is available, in which male and female Sprague Dawley rats were exposed to Bis(2-ethylhexyl) azelate (CAS 103-24-2) at dose levels of 100, 300 and 1000 mg/kg bw/day (Shirota, 2004). The test substance in corn oil was administered daily to 13 animals per sex and dose via gavage. Males were treated for a period of 42 days starting 14 days prior to mating, whereas females were exposed to the test substance 14 days prior to mating and until Day 3 of lactation. A similar constituted group received the vehicle and acted as control. No changes in testis and epididymis weight as well as histopathology of reproductive organs were observed in males. Effects on reproductive function involved a statistically significantly increased length of the oestrus cycle in females at 1000 mg/kg bw/day, whereas sperm parameters in males were not affected by treatment. The reproductive performance (copulation, fertility, gestation and implantation and delivery index) and offspring viability (birth, live birth, and viability index) were not altered after exposure to the test substance. In the offspring, no treatment-related effects on body weights and no macroscopic abnormalities were observed.
Based on the results of the study, the NOAEL for reproductive toxicity in female Sprague Dawley rats was established at 300 mg/kg bw/day, whereas the NOAEL for male Sprague Dawley rats was set at
≥
1000 mg/kg bw/day. In offspring (F1), a NOAEL for systemic toxicity of≥
1000 mg/kg bw/day was derived.
Diester of Sebacic acid
CAS 122-62-3
A four-generation study in male and female Wistar rats was performed over a period of 19 months with Bis(2-ethylhexyl) sebacate at dietary concentrations of 200 ppm, which corresponded to actual ingested doses of approximately 10 mg/kg bw/day (HPV, 2010). A further group of animals received the plain diet and served as control. During the whole study, no disturbances in growth and no pathological systems were reported in male and female animals of each generation compared to controls. At necropsy, no macroscopic or histopathological findings were detected in any treated animal. No changes in reproductive performance and no abnormalities in parturition or nursing by rats of various generations were noted. Histopathology did not reveal any changes in reproductive tissues in male or female rats.
However, the information presented in the secondary source is not sufficient to adequately cover this endpoint due to the lack of details on study performance and results.
Conclusion for toxicity to reproduction
Two oral reproduction/developmental toxicity screening tests are available within the PFAE linear category for the category members Dibutyl adipate (CAS 105-99-7) and Bis(2-ethylhexyl) azelate (CAS 103-24-2). The lowest dose descriptor derived from these studies was a NOAEL of 300 mg/kg bw/day for Bis(2-ethylhexyl) azelate (CAS 103-24-2) based on adverse effects on fertility in females (prolonged estrous stage). Similar effects have been observed with Bis(2-ethylhexyl) adipate (CAS 103-23-1) in a subacute repeated dose toxicity study according to OECD 407 (dose levels: 40, 200 and 1000 mg/kg bw/day) where findings at histopathology and in vaginal smears examinations revealed increased ovarian follicle atresia and prolongation of the estrous stage in 4/10 and 2/10 females at 1000 mg/kg bw/day, respectively. No substance-related effects were observed on sperm parameters and histopathology of reproductive organs in males (Miyata et al., 2006). In contrast, a one-generation toxicity study with the same substance (Bis(2-ethylhexyl) adipate, CAS 103-23-1) did not result in any adverse effects on fertility up to a maximum dietary dose level of 12000 ppm, which corresponded to 2102 and 2399 mg/kg bw/day in males and females, respectively.
Read-across from Bis(2-ethylhexyl) dicarboxylic acid esters can be considered as a worst case approach for the assessment of reproductive/ developmental toxicity within the category. In rats Bis(2-ethylhexyl) dicarboxylic acid esters are hydrolyzed to the dicarboxylic acid and 2-ethylhexanol, the latter of which is oxidized to ethylhexanoic acid (EHA) (Takahashi et al., 1981). EHA should be considered when addressing the reproductive toxicity of DEHA since EHA is a known reproductive toxicant. In female rats delayed estrous cycle have been observed when treated with EHA (Pennanen et al., 1993), an effect also observed in a subacute toxicity study with Bis(2-ethylhexyl)adipate and in a reproduction/developmental toxicity screening study with Bis(2-ethylhexyl) azelate: However fertility was no longer impaired in a one-generation study with Bis(2-ethylhexyl)adipate, the study with the longest treatment duration. Based a lack of effect observed in this latter study, and the strong evidence that the reproductive toxicity of DEHA is due to EHA, a metabolite only sparingly formed in monkeys, the overall NOAEL for reproduction toxicity was ≥ 2102 mg/kg bw/day, indicating no hazard for reproduction toxicity within the PFAE linear category.
Thus the overall NOAEL for reproduction toxicity was ≥ 2102 mg/kg bw/day, indicating no hazard for reproduction toxicity within the PFAE linear category.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
Short description of key information:
No hazard for reproductive toxicity was identified for the members of the PFAE linear category.
Effects on developmental toxicity
Description of key information
No hazard for developmental toxicity was identified for the members of the PFAE linear category.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for grouping of substances and read-across
The PFAE Linear (Polyfunctional Aliphatic Ester) category consists of 16 substances, well-defined mono-constituent substances as well as related UVCB substances, respectively with varying fatty alcohol chain lengths and branching. The distinguishing feature of this category of chemicals is that they are diester derivatives of common dicarboxylic acids: namely adipic (C6), azelaic (C9) and sebacic (C10) acids. The alcohol portion of the diesters generally falls in the C3-C20 carbon number range, including linear and branched, even and odd numbered alcohols.
In order to avoid the need to test every substance for every endpoint, the category concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus where applicable, environmental and human health effects are predicted from adequate and reliable data for source substance(s) within the group by interpolation to the target substances in the group (read-across approach) applying the group concept in accordance with Annex XI, Item 1.5, of Regulation (EC) No 1907/2006. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13) and within Chapter 5.1 of the CSR.
Endpoint specific data matrix:
ID # |
CAS |
Toxicity to reproduction – Developmental Toxicity oral |
Toxicity to reproduction – Developmental Toxicity dermal |
1 |
6938-94-9 (a) |
RA: CAS 103-23-1 |
-- |
2 |
105-99-7 |
RA: CAS 103-23-1 |
-- |
3 |
110-33-8 |
RA: CAS 103-23-1 |
-- |
4 |
1330-86-5 |
RA: CAS 103-23-1 |
-- |
5 |
123-79-5 (b) |
-- |
-- |
6 |
103-23-1 |
Experimental result: NOAEL maternal |
-- |
7 |
68515-75-3 |
Experimental result: NOAEL maternal |
-- |
8 |
33703-08-1 |
-- |
-- |
9 |
16958-92-2 |
RA: CAS 103-23-1 |
Experimental result: ≥ 2000 mg/kg bw/day
|
10 |
85117-94-8 |
-- |
-- |
11 |
103-24-2 |
RA: CAS 103-23-1 |
-- |
12 |
897626-46-9 |
RA: CAS 103-23-1 |
-- |
13 |
7491-02-3 |
RA: CAS 103-23-1 |
-- |
14 |
109-43-3 |
RA: CAS 103-23-1 |
-- |
15 |
122-62-3 |
RA: CAS 103-23-1 |
-- |
16 |
69275-01-0 |
-- |
-- |
(a) Category members subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.Only for these substances a full set of experimental results and/or read-across is given.
(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
(c) Original data source is not available and thus not used for read-across.
Developmental toxicity/teratogenicity
Diesters of Adipic acid
CAS 105-99-7
The developmental toxicity of Dibutyl adipate (CAS 105-99-7) was investigated in Sprague Dawley rats at dose levels of 0.1748, 0.5244, 1.0488 and 1.7480 mL/kg bw/day (Singh et al., 1973). Five pregnant females per dose group received the test substance on Day 5, 10 and 15 of gestation via intraperitoneal injection. At sacrifice on Day 20 of gestation, mean fetus weight was reduced at 1.0488 mL/kg bw/day compared to control and gross abnormalities increased with dose without reaching statistical significance. Since this test system was not suitable and no maternal toxicity was described, the study was not considered reliable for the assessment of developmental toxicity.
CAS 68515-75-3
LoA and study report not available so far
CAS 103-23-1
In a prenatal developmental toxicity study according to OECD guideline 414, the effects of Bis(2-ethylhexyl) adipate (CAS 103-23-1) on mated female Alpk:APfSD (Wistar derived) rats were investigated during Days 1 to 22 of gestation (Hodge, 1988). Groups of 24 females received the test substance at dietary concentrations of 300, 1800 and 12000 ppm, which approximately corresponded to dose levels of 28, 170 and 1080 mg/kg bw/day. A further group of 24 mated females received the plain diet and served as controls. On Day 22 of gestation, dams were sacrificed and maternal as well as foetal examinations were performed. Maternal toxicity occurred at 12000 ppm and involved a small, but statistically significant decrease in body weight gain compared to controls. This effect was accompanied by slight, statistically significant reduction in food consumption between Days 2 to 18 of gestation. No treatment-related clinical signs were observed during the study and no adverse findings were noted at macroscopic examination of dams. There was no effect at any dose level on fetal weight, litter weight, gravid uterus weight, numbers of intra-uterine deaths or numbers of external abnormalities. At 12000 ppm, a minimal increase of pre-implantation loss associated with a decrease in litter size was observed. Six major abnormalities (in five fetuses) were seen in the treated groups and eight in the control group (of which seven consisted of multiple minor skull defects in one litter). There was no evidence that the type or distribution of these abnormalities was related to test substance treatment . Overall, minor skeletal defects were increased in a dose-related manner at 1800 and 12000 ppm, while skeletal variants (as a percentage of fetuses affected) were increased at the 12000 ppm only. These findings indicated slightly poorer ossification at dose levels of 1800 and 12000 ppm, which were considered to be the result of slight fetotoxicity. However, the slightly poorer ossification is not considered as adverse effect. There was no evidence at any dose level, that the test substance was teratogenic in rats.
Based on the results of the study, the NOEL for developmental toxicity in male and female Alpk:APfSD (Wistar derived) rats was established at 300 ppm, which approximately corresponded to 28 mg/kg bw/day. The NOAEL for developmental toxicity in Alpk:APfSD (Wistar derived) rats was ≥ 12000 ppm, which is equivalent to ca. ≥ 1080 mg/kg bw/day. The NOAEL for maternal toxicity in Alpk:APfSD (Wistar derived) rats was 1800 ppm, which is equivalent to ca. 170 mg/kg bw/day.
CAS 16958-92-2
The prenatal developmental toxicity of Bis(tridecyl) adipate (CAS 16958-92-2) via the dermal route was investigated in a study similar to OECD guideline 414 (Kerstetter, 1988). Groups of 15 pregnant Sprague Dawley rats were exposed dermally to the test substance at dose levels of 800 and 2000 mg/kg bw/day. A similar constituted group of females was sham-exposed and served as control. The undiluted test substance was applied once daily to the clipped dorsal skin of the animals during Days 0 to 19 of gestation under open conditions. On Day 20 of gestation, dams were sacrificed and maternal as well as fetal examinations were performed. Only slight maternal toxicity was observed at 2000 mg/kg bw/day as indicated by a non-adverse, but significantly reduced gain in body weight compared to controls during the first and last interval of gestation, respectively. Although body weights were significantly lower at this dose level, no corresponding change in overall food consumption was noted at the end of the study compared to controls. Statistically significant differences between the serum clinical chemistry parameters from control and treated rats were observed for glucose, alanine aminotransferase (ALT), alkaline phosphatase, creatinine, cholesterol, triglycerides, total protein, iron, and globulin. However, these changes were not considered biologically significant, since they were not accompanied by any particular findings in the dams. Mild dermal irritation, including erythema and flaking of the skin, were observed in most of the animals at 800 and 2000 mg/kg bw/day. Scabs were observed at the side of test substance application in two animals exposed to 800 mg/kg bw/day. No adverse effects were observed for female reproductive parameters (number of implants,resorptions or viable fetuses). Mean fetal body weights and crown-rump lengths were not affected by exposure to the test substance. Fetal examination did not reveal any treatment-related effects on skeletal development. Although one fetus exposed in utero to 2000 mg/kg bw/day showed multiple external malformations, the effects were not considered to be a result of exposure to the test substance. Fetal visceral anomalies observed included levocardia (malrotation of the heart) and hydronephrosis as malformations after exposure to the test substance. However, only levocardia was significantly increased in the 2000 mg/kg bw/day group compared to controls. Based on the results of the study, the NOAEL for maternal toxicity in Sprague Dawley rats was set at ≥ 2000 mg/kg bw/day. For developmental toxicity, a NOAEL of 800 mg/kg bw/day was derived.
In a subsequent heart developmental toxicity study similar to OECD 414, the test substance was dermally applied to the clipped skin of 25 female Sprague Dawley rats at a limit dose of 2000 mg/kg bw/day during Days 0 to 19 of gestation (Kerstetter, 1990). Two additional groups of each 25 pregnant females were sham-exposed or treated with a negative control substance and served as control or negative control group, respectively. The dams were sacrificed on Day 20 of gestation and maternal and fetal examinations were performed. Mild dermal irritation, including erythema, edema, flaking of the skin, and scabbing, was observed in most of the animals from the treatment group and the negative control group. In the test substance-exposed and negative control animals, a statistically significant reduction in body weight was noted throughout the study compared to controls. However, this effect was not considered to be adverse. In addition, female reproductive parameters were not adversely affected by treatment with the test substance and the negative control, respectively. Determination of fetal body weights as well as external examination, and visceral examinations of foetuses did not reveal any substance-related effects. Visceral findings either occurred sporadically or were also observed in the sham-exposed control group. Heart development was not adversely affected by treatment with the test substance, and did thus no confirm the occurrence of levocardia as observed in the previous prenatal toxicity study. Based on the results of this study, the NOAEL for maternal and developmental toxicity in Sprague Dawley rats was greater than 2000 mg/kg bw/day after dermal application of Bis(tridecyl) adipate.
Conclusion for developmental toxicity/teratogenicity
One study investigating the developmental toxicity via the oral route is available for Bis(2-ethylhexyl) adipate (CAS 103-23-1). Due to the absence of any adverse effect, the NOAEL for developmental toxicity was set at ≥ 1080 mg/kg bw/day, the maximum dose administered.
Read-across from Bis(2-ethylhexyl) dicarboxylic acid esters can be considered as a worst case approach for the assessment of reproductive/ developmental toxicity within the category. In rats Bis(2-ethylhexyl) dicarboxylic acid esters are hydrolysed to the dicarboxylic acid and 2-ethylhexanol, the latter of which is also oxidized to ethylhexanoic acid (EHA) (Takahashi et al., 1981). EHA should be considered when addressing the reproductive toxicity of DEHA since EHA is a known potent reproductive and developmental toxicant. Skeletal variations and reduced fetal weight have been observed in pups of EHA treated dams (Pennanen et al., 1993). Similar effects have not been observed in the prenatal developmental study with Bis(2-ethylhexyl) adipate.
Furthermore, the prenatal developmental toxicity via the dermal route was studied with the category member Bis(tridecyl) adipate (CAS 16958-92-2). The NOAEL for dermal developmental toxicity was established at 800 mg/kg bw/day based on the incidence of levocardia at 2000 mg/kg bw/day. However, the adverse effects of Bis(tridecyl) adipate were not confirmed in a subsequent heart developmental toxicity study via the dermal route, resulting in a NOAEL for developmental toxicity of ≥ 2000 mg/kg bw/day.
Therefore, the overall NOAEL was considered to be ≥ 1080 mg/kg bw/day and no hazard for developmental toxicity was identified for the members of the PFAE linear category.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the group concept is applied to the members of the PFAE linear Category, data will be generated from representative reference substance(s) within the category to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the group concept, all available data on reproductive toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
