Registration Dossier
Registration Dossier
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EC number: 204-479-9 | CAS number: 121-54-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Reproductive toxicity
The study was designed and conducted according to The Food and Drug Administration 1966 "Guidelines for Reproduction Studies for Safety Evaluation of Drugs for Human Use", Segment I (Study of Fertility and General Reproductive Performance). Benzethonium chloride (BTC) was adminstered daily to male and female Long-Evans rats prior to (for a minimum of 60 and 15 days. respectively) and during mating, and in the females during the periods of gestation and lactation. Dosing was via oral gavage at dose levels of 1.125, 3.558 and 35.576 mg/kg/day. Mean body weight gains of the high-dose females were lower ·than those of the control females during the premating and gestation periods. Gains of the high-dose males were also slightly lower than that of the controls. The high-dose males and females also exhibited increased irritability during and after dosing as compared to animals in the other groups.The incidence of respiratory signs was also slightly greater than control in this group. Viability of pups at parturition at the high-dose level ·
was slightly lower than control; mean body weights of live pups were also slightly lower at Day 4 of lactation in this group.
Viability of pups during lactation. however was considered comparable among all groups. No effects of compound administration were indicated in the evaluation of fertility and general reproductive performance or in the necropsy-findings in adults or offspring. The NOAEL F1 was found to be 3.558 mg/kg.
Developmental toxicity
Several teratogenicity studies on rats and rabbits are available.
They were conducted according to the FDA guidelines ( e.g. Food and Drug
Administration 1966 "Guidelines for ReproductionStudies for Safety
Evaluation of Drugs for Human Use, Segment II or III or OECD no. 414.
Benzethonium chloride (BTC) was administered orally by gavage daily to
Long-Evans or Sprague-Dawely rats or New Zealand White rabbits at
different dose levels. The NOAEL ranged from 1.125 to 35.6 mg/kg for
teratogenicity, whereas the Maternal NOAEL was between 3.6 and 100
mg/kg. In one study on rats, a slight but statistically significant
decrease was noted in fetal viability for all compound-treated groups
and in postnatal survival for mid-dose and high-dose. The substance was
found to be neither teratogenic nor embryotoxic. No compound effects
were observed in any of the treatment groups for e.g. physical
observations. pregnancy rate, implantation, efficiency, percentages of
dead fetuses. crown-rump distances, sex ratios, ossification variations.
skeletal malformations or anomalies, or fetal necropsy findings.
Source:
GLP-reports (owner: Lonza)
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Species:
- rat
- Quality of whole database:
- Guideline study; Klimisch 1
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Developmental toxicity
Several teratogenicity studies on rats and rabbits are available.
They were conducted according to the FDA guidelines ( e.g. Food and Drug
Administration 1966 "Guidelines for ReproductionStudies for Safety
Evaluation of Drugs for Human Use, Segment II or III or OECD no. 414.
Benzethonium chloride (BTC) was administered orally by gavage daily to
Long-Evans or Sprague-Dawely rats or New Zealand White rabbits at
different dose levels. The NOAEL ranged from 1.125 to 35.6 mg/kg for
teratogenicity, whereas the Maternal NOAEL was between 3.6 and 100
mg/kg. In one study on rats, a slight but statistically significant
decrease was noted in fetal viability for all compound-treated groups
and in postnatal survival for mid-dose and high-dose. The substance was
found to be neither teratogenic nor embryotoxic. No compound effects
were observed in any of the treatment groups for e.g. physical
observations. pregnancy rate, implantation, efficiency, percentages of
dead fetuses. crown-rump distances, sex ratios, ossification variations.
skeletal malformations or anomalies, or fetal necropsy findings.
Source:
GLP and non-GLP-reports (owner: Lonza)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Species:
- other: rabbit & rat
- Quality of whole database:
- Guideline studies; Klimisch 1 and 2 (partly GLP)
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
According to the GHS criteria, the test item does not require any classification as reprotoxic.
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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