2-hydroxy-2-methylpropionitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: - Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1962

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Study performance before implementation of the corresponding international OECD guideline 401. However, study performance complies to a large extent to the later implemented international guideline.

GLP compliance:

not specified

Remarks:

Study performed before implementation of GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-2-methylpropionitrile

EC Number:

200-909-4

EC Name:

2-hydroxy-2-methylpropionitrile

Cas Number:

75-86-5

Molecular formula:

C4H7NO

IUPAC Name:

2-hydroxy-2-methylpropanenitrile

Details on test material:

- Name of test material (as cited in study report): alpha-Hydroxyisobutyronitrile (no further information)

Test animals

Species:

rat

Strain:

other: Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own colony of the Mellon Institute of Industrial research, Pittsburgh, Pennsylvania, U.S.A.
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: non-fasted
- Housing: no data
- Diet: Rockland rat diet
- Water (e.g. ad libitum): no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: suitable vehicle

Details on oral exposure:

- No data

Doses:

- Doses logarithmically arranged differing by a factor of two. No further information.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Range-finding toxicity data bank with several other chemicals beside the test item
- Duration of observation period following administration: 14 days
- No further information

Statistics:

Method of Thompson using the tables of Weil.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

0.017 mL/kg bw

95% CL:

11 - 26

Remarks on result:

other: original value

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

16 mg/kg bw

Remarks on result:

other: conversion of the orignial value to mg/kg/bw with a density: 0.932 g/cm³

Mortality:

- No data

Clinical signs:

other: - No data

Gross pathology:

- No data

Other findings:

- No data

Applicant's summary and conclusion

Interpretation of results:

Category 2 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Legally binding harmonised classification as given in REGULATION (EC) No 1272/2008 Annex VI Table 3.1 (GHS): Acute tox. 2*; H300 and Table 3.2 (Annex I of Directive 67/548/EEC): T+; R26/27/28

Executive summary:

In an acute oral toxicity study groups of five male Carworth Wistar rats (four to five weeks old, weight: 90 to 120 g) were given a single oral dose of alpha-Hydroxyisobutyronitrile (a.i. and % dilution unstated) in a suitable vehicle. The dosages were arranged in a logarithmic series differing by the factor of two. Animals were then observed for 14 days.

Oral LD₅₀ Males = 17 mL/kg bw (11 – 26 mL/kg bw 95% C.I.)

Legally binding harmonised classification as given in REGULATION (EC) No 1272/2008 Annex VI Table 3.1 (GHS): Acute tox. 2*; H300 and Table 3.2 (Annex I of Directive 67/548/EEC): T+; R26/27/28.