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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.