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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity rat, similar to OECD guideline 401:   LD50 = 9560 mg/kg (50% retinyl acetate solution) 
Acute oral toxicity rat, similar to OECD guideline 401:   LD50 > 2000 mg/kg (60% retinyl acetate solution) 
Acute oral toxicity rat, similar to OECD guideline 401:   LD50 > 2000 mg/kg (95% retinyl propionate)

Key value for chemical safety assessment

Additional information

In the key study for acute oral toxicity in rats similar to OECD TG 401, Vitamin A Acetat-Mutterlaugenöl, containing approx. 50% retinyl acetate, has been tested (BASF 77/998). The LD50 was reported to be 9560 mg/kg bw for males and females.  

In a supportive acute oral toxicity study in rats, using Vitamin-A-Acetat-Endoel (contains approx. 60% retinyl acetate), no mortality has been observed at the limit dose, resulting in an LD50 above 2000 mg/kg bw (BASF 10A0005/881022).

Further acute oral toxicity studies, using test substances with a retinyl acetate <=50%, confirm the findings from the given key and supporting studies. 

Furthermore, the low acute oral toxicity of retinyl-acetate in animals is confirmed by the data of the structural analogue retinyl-propionate. In an acute oral toxicity study (BASF 10A0454/891109) performed similar to OECD 401 guideline, no deaths, clinical signs of toxicity or pathological findings were noted after oral application of retinyl propionate (approx. 95% purity). The oral LD50 was > 2000 mg/kg bw in rats in this well conducted limit study.

Justification for classification or non-classification

The present data on acute oral toxicity do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and therefore, a non-classification is warranted.