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EC number: 268-460-7 | CAS number: 68092-47-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data on adverse effects on sexual function and fertility with barium m-toluate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties barium and m-toluate.
Barium m-toluate is not expected to impair fertility, since the moiety m-toluate has not shown adverse effects in a high quality combined repeated dose/ reproductive and developmental toxicity study. For the moiety barium, no classification is required based on the results of the prenatal developmental toxicity study.
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
Barium
Only two studies (NTP and Dietz) exist in which a dose-response relationship of different adverse effects on fertility after oral administration of barium chloride was investigated. These studies (see section 7.8.1) which were published in peer-reviewed journals were examined with respect to their adequacy for the derivation of NOAEL/LOAEL values for fertility impairment.
Based on these limited investigations with barium chloride as described above, a lack of fully, guideline conform data must be noted. Tentatively, the premating study by Dietz et al. (1992) on rats and mice may be considered as the only acceptable study for the derivation of a preliminary NOAEL for fertility effects of soluble barium compounds. This study investigated the occurrence of different adverse effects in male and female rats and mice and their offspring related to barium chloride exposure via drinking water. A tentative NOAEL for fertility impairment of 4,000 ppm in rats and 2,000 ppm in mice can be derived.
Screening study:
Fertility impairment in female rats: NOAEL of 179.5 mg Ba2+/kg bw/d; relates to 272 mg Barium chloride/kg bw/day (Dietz et al., 1992)
Fertility impairment in male rats: NOAEL of 201.5 mg Ba2+/kg bw/d; relates to 306 mg Barium chloride/kg bw/day (Dietz et al., 1992)
A screening test is available. Based on this study there are no indications of a substantial impairment of fertility in rats up to the highest dose tested. Thus, the NOAEL was 4000 ppm (to average doses of 201.5 and 179.5 mg Ba/kg bw/d to male and female rats, respectively). No-observed-adverse-effect levels (NOAELs) on developmental toxicity for rats of 4000 ppm were derived. However, this NOAEL is of limited value to evaluate the potential for barium to induce developmental effects because there was no exposure of the females during gestation.
For the endpoint developmental toxicity, which is not a Reach Annex VIII (10-100 t/a) requirement, no robust study summaries were obtained. However, the license to use includes information that is included in the endpoint summary of IUCLID section 7.8 “Toxicity to reproduction”. Thus, a conclusion on developmental toxicity can be drawn based on the information stated therein (for detailed information please refer to the registration dossier of barium dichloride):
Developmental toxicity of barium chloride dihydrate was evaluated in a recent prenatal developmental toxicity study by daily administration of the test item at dose levels of 0, 10, 30 or 100 mg BaCl2 * 2 H2O/kg body weight to pregnant rats from gestation day 1 up to and including gestation day 20. No effects on body weights, food consumption and clinical signs were observed. Maternal toxicity was evidenced by the spontaneous deaths of two animals on gestation day 21 only and the conditional decline of another animal on gestation day 21 in the high dose group (100 mg BaCl2 * 2 H2O/kg bw).
No developmental toxicity or treatment-related observations, whatsoever in external, visceral and skeletal foetal examinations were observed in any dose level.
The NOAEL for maternal toxicity was therefore 30 mg/kg body weight barium chloride dihydrate (25.6 mg/kg bw barium chloride)). In absence of developmental effects, the NOAEL for prenatal developmental toxicity in the rat was ≥ 100 mg/kg body weight barium chloride dihydrate (≥85.3 mg/kg bw barium chloride).
Furthermore, tentative NOAEL values for developmental toxicity of 4,000 ppm and 2,000 ppm for rats and mice, respectively, are also reported in the study by Dietz et al. (1992). However, these NOAELs are of limited value to evaluate the potential for barium to induce developmental effects because the study design did not include prenatal exposure of the female animals to barium dichloride dihydrate.
Developmental toxicity: a NOAEL of >=85.3 mg BaCl2/kg was derived in an oral developmental toxicity study according to OECD 414.
No classification is required based on the results of the prenatal developmental toxicity study.
m-toluate
In the combined repeated dose/ reproductive and developmental toxicity test (OECD 422; GLP), rats were exposed to 30, 100, 300 and 1000 mg/kg bw/day m-toluic acid for 41 to 45 days. Reproductive parameters in parental animals were examined and no adverse effects were observed. Offspring parameters were examined and no adverse effects were observed. Thus, the reproductive NOAEL was considered at 1000 mg/kg bw/day.
Barium m-toluate
Barium m-toluate is not expected to show effects on fertility or development of the offspring, since the moiety m-toluate has not shown adverse effects a high quality combined repeated dose/ reproductive and developmental toxicity study. For the moiety barium, no classification is required based on the results of the prenatal developmental toxicity study. For the endpoint developmental toxicity, which is not a Reach Annex VIII (10-100 t/a) requirement, no robust study summaries were obtained. However, the license to use includes information that is included in the endpoint summary of IUCLID section 7.8 “Toxicity to reproduction”. Thus, a conclusion on developmental toxicity can be drawn based on the information stated therein. Thus, barium m-toluate is not to be classified according to regulation (EC) 1272/2008 for reproductive toxicity. Further testing is not required. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.
Information on the individual moieties barium and m-toluic acid will be used for the hazard assessment and, when applicable, for the risk characterisation of barium m-toluate. For the purpose of hazard assessment of barium m-toluate, the point of departure for the most sensitive endpoint of each moiety will be used for the DNEL derivation. In case of m-toluic acid in barium m-toluate, the NOAEL of 100 mg/kg bw/day for repeated dose toxicity will be used. In case of barium, the NOAEL of 61 mg/kg bw/day for repeated dose toxicity will be used.
Effects on developmental toxicity
Description of key information
No data on developmental toxicty with barium m-toluate are available, thus the reproductive toxicity will be addressed with existing data on the individual moieties barium and m-toluate.
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 study available
Additional information
Barium
For the endpoint developmental toxicity, which is not a Reach Annex VIII (10-100 t/a) requirement, no robust study summaries were obtained. However, the license to use includes information that is included in the endpoint summary of IUCLID section 7.8 “Toxicity to reproduction”. Thus, a conclusion on developmental toxicity can be drawn based on the information stated therein (for detailed information please refer to the registration dossier of barium dichloride):
Developmental toxicity of barium chloride dihydrate was evaluated in a recent prenatal developmental toxicity study by daily administration of the test item at dose levels of 0, 10, 30 or 100 mg BaCl2 * 2 H2O/kg body weight to pregnant rats from gestation day 1 up to and including gestation day 20. No effects on body weights, food consumption and clinical signs were observed. Maternal toxicity was evidenced by the spontaneous deaths of two animals on gestation day 21 only and the conditional decline of another animal on gestation day 21 in the high dose group (100 mg BaCl2 * 2 H2O/kg bw).
No developmental toxicity or treatment-related observations, whatsoever in external, visceral and skeletal foetal examinations were observed in any dose level.
The NOAEL for maternal toxicity was therefore 30 mg/kg body weight barium chloride dihydrate (25.6 mg/kg bw barium chloride)). In absence of developmental effects, the NOAEL for prenatal developmental toxicity in the rat was ≥ 100 mg/kg body weight barium chloride dihydrate (≥85.3 mg/kg bw barium chloride).
Furthermore, tentative NOAEL values for developmental toxicity of 4,000 ppm and 2,000 ppm for rats and mice, respectively, are also reported in the study by Dietz et al. (1992). However, these NOAELs are of limited value to evaluate the potential for barium to induce developmental effects because the study design did not include prenatal exposure of the female animals to barium dichloride dihydrate.
Developmental toxicity: a NOAEL of >=85.3 mg BaCl2/kg was derived in an oral developmental toxicity study according to OECD 414.
No classification is required based on the results of the prenatal developmental toxicity study.
m-toluate
In the combined repeated dose/ reproductive and developmental toxicity test (OECD 422; GLP), rats were exposed to 30, 100, 300 and 1000 mg/kg bw/day m-toluic acid for 41 to 45 days. Reproductive parameters in parental animals were examined and no adverse effects were observed. Offspring parameters were examined and no adverse effects were observed. Thus, the reproductive NOAEL was considered at 1000 mg/kg bw/day.
Barium m-toluate
Barium m-toluate is not expected to show effects on fertility or development of the offspring, since the moiety m-toluate has not shown adverse effects a high quality combined repeated dose/ reproductive and developmental toxicity study. For the moiety barium, no classification is required based on the results of the prenatal developmental toxicity study. For the endpoint developmental toxicity, which is not a Reach Annex VIII (10-100 t/a) requirement, no robust study summaries were obtained. However, the license to use includes information that is included in the endpoint summary of IUCLID section 7.8 “Toxicity to reproduction”. Thus, a conclusion on developmental toxicity can be drawn based on the information stated therein. Thus, barium m-toluate is not to be classified according to regulation (EC) 1272/2008 for reproductive toxicity. Further testing is not required. For further information on the toxicity of the individual moieties, please refer to the relevant sections in the IUCLID and CSR.
Information on the individual moieties barium and m-toluic acid will be used for the hazard assessment and, when applicable, for the risk characterisation of barium m-toluate. For the purpose of hazard assessment of barium m-toluate, the point of departure for the most sensitive endpoint of each moiety will be used for the DNEL derivation. In case of m-toluic acid in barium m-toluate, the NOAEL of 100 mg/kg bw/day for repeated dose toxicity will be used. In case of barium, the NOAEL of 61 mg/kg bw/day for repeated dose toxicity will be used.
Justification for classification or non-classification
For the moiety barium, no classification is required based on the results of the prenatal developmental toxicity study.
Data on the reproductive toxicity of m-toluic acid is available from a reproductive/developmental toxicity screening test according to OECD guideline 422. Rats were dosed from 14 days before mating (males and females) to day 3 of lactation (females only). m-Toluic acid did not impair sexual function, fertility or the development of the offspring up to and including the limit test dose of 1000 mg/kg bw/d.
According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, barium m-toluate does not have to be classified and has no obligatory labelling requirement for reproductive toxicity.
Additional information
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