Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to standards

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)
Principles of method if other than guideline:
The study was conducted according to an internal BASF method.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-tert-butylbenzaldehyde
EC Number:
213-367-9
EC Name:
4-tert-butylbenzaldehyde
Cas Number:
939-97-9
Molecular formula:
C11H14O
IUPAC Name:
4-tert-butylbenzaldehyde
Details on test material:
- Name of test material (as cited in study report): 4-tert-butylbenzaldehyde (p-tert.butyl-benzaldehyde)
- Analytical purity: 98 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 15-20 h prior to application of the test material
- Diet: Herilan MRH Haltung (H Eggersmann KG), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Application volume: 10 ml/kg bw
Concentration of the test material in vehicle: 0.147, 0.215, 0.316, 0.464 and 0.681 % (w/v)
Doses:
14.7, 21.5, 31.6, 46.4 and 68.1 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
Observation period: 14 d.
Body weight determined before the start of the study, after 2-4 days, 7 days and 9-13 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
Statistics: following Finney D.J.: Probit analysis, Cambridge University Press, 3rd ed., 1971

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
50.6 mg/kg bw
Mortality:
For details on mortality, see "Remarks on results ...".
Clinical signs:
other: Symptoms observed - Dyspnoe - Apathy - Abnormal position - Staggering - Atony - Narcotic (high dose only) - No pain reflex (high dose only) - No corneal reflex (high dose only) - Spastic movement - Ruffled fur - Diarrhea - Cyanosis - Exsiccosis - Exophta
Gross pathology:
Dead animals:
- Heart: acute dilatation on the right side; acute congestion hyperemia.
- Liver: clay-like coloured due to slightly broadened Lobuli hepatici.
- Kidneys: brightened (nephrosis).

Sacrificed animals:
No substance-related effects.

Any other information on results incl. tables

Table 1: Mortality data

Dose Mortality after
mg/kg 1 h 1 d 2 d 7 d 14 d
-----------------------------------------------
68.1 M 0/5 2/5 2/5 3/5 3/5
F 0/5 5/5 5/5 5/5 5/5
46.4 M 0/5 2/5 2/5 2/5 2/5
F 0/5 2/5 2/5 2/5 2/5
31.6 M 0/5 0/5 0/5 0/5 0/5
F 0/5 1/5 1/5 1/5 1/5
21.5 M 0/5 0/5 0/5 0/5 0/5
F 0/5 0/5 0/5 0/5 0/5
14.7 M 0/5 0/5 1/5 1/5 1/5
F 0/5 0/5 0/5 0/5 0/5
------------------------------------------------
M = males, F = females

Applicant's summary and conclusion