Registration Dossier
Registration Dossier
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EC number: 806-731-9 | CAS number: 1428353-74-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No data is available on the registered substance. A weight of evidence approach is used.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
To date, there is no existing reproductive and developmental toxicology data on the registered substance (CASRN 1428353-74-5); however, reproductive and developmental toxicity data exist for glycerol (CASRN 56-81-5), amines, coco, N, N-bis (hydroxyethyl) (CASRN 68603-42-9), and for boric acid (CASRN 10043 -35-3), breakdown products of the substance to be registered. Additionally, a repeated dose dermal study conducted on borated glycerol monooleate (CASRN 63310-16-7) demonstrates no toxicological effects to male and female reproductive organs (Table 1.) The read across reproductive and developmental data presented below demonstrates that the substance to be registered is not expected to be a reproductive and/or a developmental toxicant.
A two-generation fertility study conducted on rats demonstrated that glycerin (CASRN 56-81-5), administered via oral gavage, had no effect on growth, fertility, or reproductive performance (Wegener, 1953). Administration of 1.0 ml/kg (50% aqueous glycerol solution) to rats had no adverse effects on development, survival, internal organs, skeletal system, or hepatic glycogen (Loeser et al., 1954). Likewise, another developmental toxicity set of studies conducted on mice, rats, and rabbits demonstrated no effect on developmental toxicity of offspring of female animals dosed with glycerin (NTIS, 1974). These studies clearly highlight that glycerin is not a reproductive or a developmental toxicant.
A developmental study (similar to OECD 414) conducted (oral exposure) on CASRN 68603-42-9 resulted in maternal and developmental NOAELs greater than the highest dose tested, 1000 mg/kg/day. The only recorded treatment related effects were salivation and propulsion of the head during dose administration. This study validates that this substance is not expected to be a reproductive or a developmental toxicant.
Animal studies investigating the reproductive toxicity of boric acid have resulted in decreased sperm viability and testicular atrophy in males and decreased ovulation in females. These effects occurred at very high doses that exceed human exposure levels. Epidemiological studies have not discovered adverse reproductive effects in even the highest exposed group- workers who mine and refine borates. These human studies are considered inconclusive due in part to the low sample size and have been considered insufficient by ECHA for the hazard evaluation of boric acid. The substance to be registered does not contain detectable levels of residual boric acid and will not hydrolyze to boric acid under normal use conditions to the worker or consumer. In the worst case scenario, the dermal absorption of boric acid in humans is relatively low at <0.3% (Draize and Kelley, 1959) and would not pose a risk for reproductive or developmental toxicity via dermal route. A repeated dose dermal study conducted on a similar borated material (CASRN 91052-28-7) via dermal route demonstrated a NOEL greater than 1ml/kg (neat). Changes to reproductive organs were not considered biologically significant due to the absence of other histopathological changes.
Table 1. Reproductive and Developmental Toxicity
CAS Number | OECD/Method | Result | Reference |
56-81-5 | Reproductive Toxicity – 2-generation | NOEL = ~ 2000 mg/kg/day (rat) | Wegener, 1953 |
Developmental Toxicity | NOAEL = 1.0 ml/kg (50% aqueous glycerol solution) (rat) | Loeser et al., 1954 | |
NOEL = 1310 mg/kg/day (rat) NOEL = 1280 mg/kg/day (mouse) NOEL = 1180 mg/kg/day (rabbit) (Similar to OECD 414) | NTIS US Dept. of Commerce 1974 | ||
68603-42-9 | Similar to OECD 411 | No effects on reproductive organs in 14-week dermal repeated-dose toxicity study in rats | NTP, 2001 |
Developmental Toxicity | NOAEL (maternal) = 1000 mg/kg/day NOAEL (dev.) = 1000 mg/kg/day | EPA HPV, 2001 | |
10043-35-3 | Reproductive Toxicity – 3-generation | Fertility:Primary target =male reproductive system (testicular damage). Female reproduction (general toxicity) is also adversely affected (rat, mouse, dog). NOAEL = 17.5 mg boron/kg bw/day (rat) | ECHA Transitional Report 2010 – Weir & Fisher, 1972 |
Developmental Toxicity – OECD 414 | NOAEL = 9.6 mg boron/kg bw/day (rat) Fetal toxicity in the absence of maternal toxicity, specifically a reduction of fetal body weight and rib anomalies.
| ECHA Transitional Report 2010 | |
63310-16-7 | OECD 407 | No male or female reproductive target organ effects, NOEL = ca. 1.0 ml/kg (highest dose tested) | Duke et al.,1982 |
Additionally, a repeated dose dermal toxicity study demonstrated no toxicological effects on male and female reproductive organs resulted from administration of 5.0 g/kg of undiluted CASRN63310-16-7 to abraded skin. Study results indicated no deaths or signs of toxicity in all five rabbits of each sex during the study. Additionally, no gross pathological changes were shown to be attributed to administered test material at necropsy.
Collectively,these studies demonstrate that substance to be registered does not meet the criteria to be classified as a reproductive toxicant according to CLP.
REFERENCES
Duke, C.E., Cisson, C.M., and Wong, Z.A. 1982. Twenty-eight Day Repeated Dermal Study of [redacted] in Adult Male and Female Rats. Internal Chevron Environmental Health Center. Report No. SOCAL 1873.
Draize, JH and Kelley, EA. 1959. The urinary excretion of boric acid preparations following oral administration and topical applications to intact and damaged skin of rabbits.Toxicol Appl Pharmacol1:267-276.
ECHA Transitional Annex XV Dossier on Boric Acid. 2010
Environmental Protection Agency (EPA) Fatty Nitrogen Derived Amides High Production Volume (HPV) Chemicals Challenge. 2001
Loeser, A., Bornmann, C., Crosskinsky, L., Hess, G., Kopf, R., Ritter,K.,Schmitz, A., Stuermer, E., and Wegener, H.(1954).Diethylene glycol. Pharmacology and toxicology of polyglycols. Naunyn-SchmiedebergsArch.Expt. Pathol. Pharmakol.221, 14-33.In:Informatics,Ref.69.
National Toxicology Program (NTP). 2001. “Diethanolamine Condensate (CAS No. 68603-42-9) in F344/N Rats and B6C3F1 Mice (Dermal Studies)”. NTP TR 479/NIH. Publication No. 01-3969.
NTIS US Department of Commerce. 1974. Teratological evaluation of glycerine in mice, rats and rabbits. Report No. PB-234876.
Wegener, H. 1953. Über die Fortpflanzungsfähigkeit der Ratte nach Einwirkung von Diäthylenglykol. Arch exper Path u Pharmakol,220:414-417
Weir, RJ and Fisher, RS. 1972. Toxicologic studies on borax and boric acid. Toxicol Appl Pharmacol. 23: 351-364.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-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.
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