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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

 The derived LD 50 value for acute oral toxicity is 178 mg/kg bw  (Hüls, 1985) for Isophorone nitrile. Thus the substance is regarded and classified as toxic if swallowed. Because of a LD50 value for acute dermal toxicity of more than 2000 mg/kg b.w in rabbits (Asta, 1990), the test item showed very low dermal toxicity under conditions the conducted study. According to the outcome of an acute inhalation study with rats (RCC, 1999; LC50 1.34 mg/l air ) Isophorone nitril is regarded and classified as harmful by inhalation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
178 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
1 340 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Studies in animals:

Oral exposure:

Two oral acute toxicty studies in rats were conducted with the test item Isophorone nitrile. The derived LD 50 values are 178 mg/kg bw (Hüls, 1985) and 272 mg/kg (Asta, 1990). Because of identical reliability codes and because of worst case considerations the study with the lowest LD 50 value (Hüls, 1985) was choosen to be the key study. According to the outcome of the (key) study Isophorone nitrile is regarded and classified as toxic if swallowed.

Dermal exposure:

In a dermal acute toxicity test the determined LD50 value for male and female rabbits was above 2000 mg/kg b.w. (Asta, 1990). Thus, the test item showed very low dermal toxicity under conditions this study.

Inhalative exposure:

An acute inhalation study was conducted in rats (RCC, 1999). The LC 50 of isophorone nitrile for acute inalation toxicity (4 h) was estimated to be 1.34 mg/l air in rats. Because of this result the test item Isophorone nitril is regarded and classified as harmful by inhalation.


Justification for classification or non-classification

The substance 3-cyano-3,5,5-trimethylcyclohexanone (Isophorone nitrile) is classified according to the criteria of EC Directive 67/548/EEC as follows: "Toxic if swallowed" (T, R 25) and "Harmful by inhalation" (Xn, R 20)