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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

DIBN is instable under normal conditions and testing is not feasible due to technical reasons according REACH Regulation (EC) no 1907_2006 Annex XI.
However 2 studies concerning acute oral and dermale toxicity with a mixture of approx. 20% diisobutylene nitrosate and approx. 80% diisobutylene are available as secondary literature

Key value for chemical safety assessment

Additional information

Diisobutylene nitrosate (approximately 20% pure) was administered as a single oral dose (200, 300, 450, 670, 1000, 1500, 2300, 3400 mg/kg bw) by gastric intubation to male rats. The lowest dose of diisobutylene nitrosate where one animal died was 450 mg/kg bw. The survival of the rats dosed at 670 mg/kg bw or 1000 mg/kg bw was attributed to animal variability and does not change the ALD (approximate lethal dose).

Diisobutylen nitrosate (approx. 20% pure) was applied to the clipped, intact skin of 1 male New Zealand White rabbit each at a dose of 1000, 2300 or 3400 mg/kg bw. Additionally 2 rabbits were dosed at 5000 mg/kg bw. The test sites were occluded for 24 hours. Observations for mortality were made daily for 14 days after treatment.

The 2 rabbits treated with 5000 mg/kg bw died within 6 hours following application of the test material; no other deaths occured.

Under the conditions of this test, the ALD was 5000 mg/kg of body weight.

Justification for classification or non-classification

Only one dose/per animal (2 animals/dose at 5000 mg/kg bw in the dermal study) were used. Therefore an reliable calculation of the LD50 values is only possible with restrictions.

In the acute oral toxicity study the test material was considered to be moderately toxic (ALD 50 - 500 mg/kg) by the author of the study when administered as a single oral dose.

In the acute dermal toxicity study the test material is considered to be slightly toxic (ALD 500 - 5000 mg/kg bw) by the author of the study when applied to the clipped, intact skin of male rabbits.

As diisobutylene nitrosate has 2 nitro groups per molecule as functional groups, the observed clinical signs and the determined ALD ranges a classification as T, R23/24/25 (toxic by inhalation, in contact with skin and if swallowed) seems justified.