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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
0.017 mL/kg bw
95% CL:
11 - 26
Remarks on result:
other: original value
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.