Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Available acute toxicity values for isopropyl acetate are:
Oral LD50 (rat) - 3000, 6750, 10900, 14964 mg/kg. 7.07, 9.85, 10.4, 11.3ml/kg. Oral LD50 (mouse) - 6650mg/kg. Oral LD50 (rabbit): 6945
Inhalation 8-hr LC50 (rat) - 50,600 mg/m3 (reliable study). LC0 (30mins) >133,669mg/l. LC100 (4hrs) <133669mg/l
Dermal LD50, 24-hr occlusive exposure (rabbit) - >17.4 g/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
6 750 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
50 600 mg/m³ air

Additional information

Acute oral LD50 values have been reported for isopropyl acetate in rats, mice and rabbits. The reported LD50 values range from 3000 mg/kg to 14,964 mg/kg. The two most robust studies are in rabbits and rats and report very similar LD50 values of 6945 and 6750mg/kg respectively. Whilst all the data is quite old, it consistently shows that this substance has a low acute oral toxicity and this information is deemed sufficient to fulfill the requirements of this end point.

Acute inhalation LC50 values have been reported for isopropyl acetate in rats and mice. The key acute inhalation toxicity study of isopropyl acetate by Pozzani et al (1959) reported an 8 -hr LC50 value of 50,600 mg/m3 in rats. Another study observed no deaths following exposure of rats to a concentration of aroudn 133,000mg/m3 but 5 out of 6 animals died after 4 hours exposure.

The key acute dermal toxicity study of isopropyl acetate by Smyth et al (1954) reported an LD50 value of >20 ml/kg (>17.4 g/kg), (24 -hr occlusive exposure). This was the maximum dose that could be tested using the method.

Justification for classification or non-classification

Based on the available animal data, there is sufficient information available to determine that no classification is required for any route of acute exposure.

Based on limited data available for isopropyl acetate and similar substances (from both repeat and single exposure studies), classification is recommended warning that exposure to high concentrations of isopropyl acetate vapours may cause narcosis (STOT-SE category 3 under regulation 1272/2008. R67 unde directive 67/548).