Reaction mass of calcium dihydroxide and calcium peroxide

Endpoint summary

Description of key information

Acute toxicity: via oral route

Key study: OECD Guideline 401. GLP study. The oral LD50 of the test item was determined to be greater than 5000 mg/kg bw to both male and female rats.

Acute toxicity: via dermal route

Key study: OECD Guideline 402. GLP study. The dermal LD50 of the test item was determined to be greater than 2000 mg/kg bw to female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Only one study of Klimisch 1 available.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute toxicity: via oral route

Key study: An acute oral toxicity test was performed according to OECD Guideline 401 (GLP study). Ten Sprague-Dawley rats (5 males and 5 females) were orally dosed with test item at a dose level of 5000 mg/kg bw in corn oil. Clinical signs and body weight gains were assessed during the study. Gross necropsy was performed on all animals. There were no deaths. Abdominogenital staining and diarrhea were noted in several rats shortly after dosing. All rats recovered by day 2 and remained healthy throughout the study. All rats gained weight by day 14 of the study. There were no gross internal lesions observed in any animal. Based on these results, the oral LD50 of the test item was determined to be greater than 5000 mg/kg bw to both male and female rats.

Acute toxicity: via dermal route

An acute dermal toxicity limit test was performed according to OECD Guideline 402 (GLP study). The test item was administered to one female Wistar rat by a single dermal application at 1000 mg/kg and 2000 mg/kg body weight each for 24 hours in a range finding study. Based on the results, the main study was performed by dosing two females at 2000 mg/kg.  All animals were subjected to daily observations and weekly determination of body weight for 14 days.  Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). No mortality ocurred at any dose tested. No significant signs of systemic toxicity were noted at 1000 mg/kg. At 2000 mg/kg, fissures, scales, scabs, general erythema and/or white staining were seen in the treated skin-area of the animals between Days 2 and 15.  Scabs and/or focal erythema were noted on the back of two animals between Days 8 and 15. Chromodacryorrhoea of the nose was noted for two animals on Day 1. Based on the study results, the dermal LD50 value of the test item in Wistar rats was established to exceed 2000 mg/kg body weight.  

Justification for classification or non-classification

Based on the available information (oral LD50 > 5000 mg/kg bw in rats; dermal LD50 > 2000 mg/kg bw in rats), the substance is not classified for acute toxicity according to the CLP Regulation (EC) no. 1272/2008.