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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific principles with acceptable deviations.

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 402 (Acute Dermal 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): p-Tertiaerbutyl-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
- Weight at study initiation: males: ca. 225 g; females: ca. 174 g

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: ca. 50 cm2

TEST MATERIAL
- Concentration: 25 (200 mg/kg bw), 50 (400 mg/kg bw) or 100 % (1000 and 2000 mg/kg bw) of the test substance in vehicle
Duration of exposure:
24 h; the test material was not rinsed.
Doses:
200, 400, 1000 and 2000 mg/kg bw
No. of animals per sex per dose:
3 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: The animals were weighed prior to exposure of the test material, on day 2, 7 and on day 13 and observed for clinical signs on working days.
- Necropsy performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
1/6 animals of the 2000 mg/kg dose group died within the first two days.
All other animals survived.
Clinical signs:
other: 2000 mg/kg : dyspnea, apathy, tremor, diarrhea, generally bad condition 1000 mg/kg : dyspnea, apathy, aggressiveness ; staggering, spastic movement, morphine tail, generally bad condition 400 mg/kg : dyspnea, apathy, excitation, staggering, spastic moveme
Gross pathology:
Dead animal:
Heart: acute dilatation on the right side; acute congestion hyperemia.
Lung: acute and moderate exhalation.
Liver: brightened, clay-like coloured, broadened Lobuli hepatici.

Sacrificed animals:
No substance-related effects.
Other findings:
Local irritation effects:
2000 mg/kg: after 24 hours very slight redness and slight edema;
1000 - 200 mg/kg: skin partly splotched and anaemic, slight edema.

All observations were reversible within 7 d.

Applicant's summary and conclusion