Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: dermal
Remarks:
other: short-term
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Not enough data for assessment

Data source

Referenceopen allclose all

Reference Type:
other:
Title:
No information
Year:
1990
Bibliographic source:
BIBRA Toxicity Profile Vanilline 121-33-5
Reference Type:
publication
Title:
Problem of the toxicity of vanillin
Author:
Makaruk MI
Year:
1980
Bibliographic source:
Gig Sanit, 6, 78-80

Materials and methods

Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Vanillin
EC Number:
204-465-2
EC Name:
Vanillin
Cas Number:
121-33-5
Molecular formula:
C8H8O3
IUPAC Name:
4-hydroxy-3-methoxybenzaldehyde
Details on test material:
no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on exposure:
no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
10 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
408 mg/kg/day
Basis:
no data
No. of animals per sex per dose:
no data
Control animals:
yes
Details on study design:
no data
Positive control:
no data

Examinations

Observations and examinations performed and frequency:
no data
Sacrifice and pathology:
no data
Other examinations:
no data
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Haematological findings:
effects observed, treatment-related
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
by immersion of 2/3 of the tail in a 5% oil solution:
no death; unchanged aspect and behaviour;
slight loss of body weight; reduction in the number of red blood cells and in the haemoglobin level; affected liver function (as increase in the
barbiturate-induced sleeping time); hypereamia of the liver and spleen

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion