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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Anisaldehyde
EC Number:
204-602-6
EC Name:
Anisaldehyde
Cas Number:
123-11-5
Molecular formula:
C8 H8 O2
IUPAC Name:
4-methoxybenzaldehyde
Details on test material:
- Name of test material (as cited in study report): Anisaldehyd
- Physical state: liquid
- Analytical purity: > 99 % (data from order sheet)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hagemann
- Mean weight at study initiation per test group: 170-260 g (males), 170-190 g (females)
- Fasting period before study: 15-20 h
- Diet: Herilan MRH-Haltung, H. Eggersmann KG; ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
aqueous 0.5% CMC solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 4.64 - 50%

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
464, 2150, 3160, 3830, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weighing was performed at the beginning of the study and on days 4, 7 and 13. Observation of clinical signs was done several times on the day of administration and once daily afterwards with the exception of weekends and on holidays
- Necropsy of survivors performed: yes
Statistics:
According to Finney, D.J.: Probit Analysis, Cambridge University Press, 3rd ed., 1971

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 210 mg/kg bw
Based on:
test mat.
95% CL:
2 755 - 3 600
Mortality:
5000 mg/kg bw: 10/10 animals (5/5 males died within one day; 4/5 females died within one day, the last female within 7 days)
3830 mg/kg bw: 7/10 animals (2/5 males died within 7 days; 5/5 females died within one day)
3160 mg/kg bw: 6/10 animals (2/5 males died within one day; 4/5 females died within one day)
2150 mg/kg bw: 0/10 animals
464 mg/kg bw: 0/10 animals
Clinical signs:
other: 5000 mg/kg bw: dyspnoea, apathy, abnormal position, staggering, atonia, narcotic-like behaviour, missing pain reflex, twitching, skin redness, ruffled fur, exsiccosis and poor general state before exitus 3830 mg/kg bw: dyspnoea, apathy, abnormal positi
Gross pathology:
Animals that died: dilatation of the urinary bladder, oedemateous liver parenchym, single hemorrhagic erosions of the gastreous mucosa
Sacrificed animals: no abnormalities

Applicant's summary and conclusion