Sodium 3-chloro-2-hydroxypropanesulphonate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Oral: OECD 422, rat. Reproductive NOEL: 1000 mg/kg/day (highest dose tested). Reliability = 1.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Study duration:

subacute

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

The potential toxic effects of the test substance were evaluated when administered to rats for 28 days and to evaluate the potential of the test substance to affect male and female reproductive performance such as gonadal function, mating behavior, and conception through Day 13 of postnatal life. The test substance in the vehicle (0.5% carboxymethylcellulose and 0.1% Tween® 80 in deionized water, pH 3.5) was administered orally by gavage once daily to 3 groups of Crl:CD(SD) rats, each group consisting of 10 males and 10 females. Dosage levels were 250, 500, and 1000 mg/kg/day. A concurrent control group of 10 rats/sex received the vehicle on a comparable regimen. Mean body weights, body weight gains, and food consumption for F0 males and females at 250, 500, and 1000 mg/kg/day were unaffected by test substance administration throughout the study. F0 estrous cycle length, reproductive performance (mating, fertility, and copulation/conception indices), gestation length, and parturition were unaffected by test substance administration. No test substance-related effects were noted during the FOB or motor activity evaluations at any dosage level in the F0 generation. There were no test substance-related effects on the mean number of implantation sites and unaccounted-for sites in the 250, 500, and 1000 mg/kg/day groups. There were no test substance-related macroscopic or microscopic findings, or effects on clinical pathology parameters and organ weights noted for F0 males and females at any dosage level. There were no test substance-related effects on thyroid hormone values noted for F0 males or F1 pups on PND 13 at any dosage level. There were no test substance-related effects on the number of F1 pups born, live litter size, percentage of males at birth, F1 clinical observations, postnatal survival and growth, anogenital distance, or areolae/nipple anlagen. There were no test substance-related macroscopic findings for F1 pups that were found dead or at the PND 13 scheduled necropsy at any dosage level. There were no test substance-related changes in thyroid/parathyroid weights in F1 males and females on PND 13. Under the conditions of this screening study, no test substance-related effects were noted at any dosage level. Therefore, a dosage level of 1000 mg/kg/day, the highest dosage level evaluated, was considered to be the no-observed-effect level (NOEL) for F0 reproductive toxicity, F0 parental systemic toxicity, and F1 neonatal toxicity of the test substance when administered orally by gavage to Crl:CD(SD) rats.

Effects on developmental toxicity

Description of key information

Oral: NOAEL; OECD 422, rat. NOEL for developmental toxicity was 1000 mg/kg/day (highest dose tested). Reliability = 1.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

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

The objectives of the study were to evaluate the potential toxic effects of the test substance, when administered to rats for 28 days. The test substance, in the vehicle (0.5% carboxymethylcellulose and 0.1% Tween® 80 in deionized water, pH 3.5) was administered orally by gavage once daily to 3 groups of Crl:CD(SD) rats, each group consisting of 10 males and 10 females. Dosage levels were 250, 500, and 1000 mg/kg/day. A concurrent control group of 10 rats/sex received the vehicle on a comparable regimen. Males received a total of 28–29 doses and females received a total of 52 doses. All animals were observed for mortality and morbundity. Clinical observations, body weight, and food consumption, FOB and motor activity data, clinical pathology, macroscopic and microscopic (control and high dose only) examinations were performed. All F0 males and females in the 250, 500, and 1000 mg/kg/day groups survived to the scheduled necropsies. Two F0 females in the control group were found dead or euthanized in extremis during the study. No test substance-related clinical observations were noted at the daily examinations, detailed physical observations, or approximately 2 hours following dose administration at any dosage level. Mean body weights, body weight gains, and food consumption for F0 males and females at 250, 500, and 1000 mg/kg/day were unaffected by test substance administration throughout the study. No test substance-related effects were noted during the FOB or motor activity evaluations at any dosage level in the F0 generation. There were no test substance-related macroscopic or microscopic findings, or effects on clinical pathology parameters (haematology, coagulation, serum chemistry) and organ weights noted for F0 males and females at any dosage level. There were no test substance-related effects on thyroid hormone values noted for F0 males at any dosage level. Under the conditions of this screening study, no test substance-related effects were noted at any dosage level. Therefore, a dosage level of 1000 mg/kg/day, the highest dosage level evaluated, was considered to be the no-observed-effect level (NOEL) F0 parental systemic toxicity, of the test substance when administered orally by gavage to Crl:CD(SD) rats.

Justification for classification or non-classification

Based on a NOEL of 1000 mg/kg (highest dose tested) in an OECD 422 repeated dose/reproductive/developmental screening study, the substance does not need to be classified for reproductive or developmental toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.