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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 29 January to 12 February 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted in a similar manner to validated testing guidelines. Study pre-dates GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Principles of method if other than guideline:
One group of ten (5 male and 5 female) albino rats was used in this study. The rats were placed in a 70 liter, all glass exposure chamber and exposed air for one hour. Following 14 days observation period during which time the rats were abserved for signs of toxicity and mortalities.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
EC Number:
239-816-9
EC Name:
Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine
Cas Number:
15721-78-5
Molecular formula:
C28H43N
IUPAC Name:
4-(2,4,4-trimethylpentan-2-yl)-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]aniline
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch No.: not specified.
Purity: not specified.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
None stated.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE
- Exposure apparatus: Glass exposure chamber
- Exposure chamber volume: 70 liter
- Source and rate of air: The rate of flow was 10 liters per minute.
- Temperature, humidity, pressure in air chamber: 70 °F

VEHICLE
- Composition of vehicle (if applicable): Corn oil.
- Concentration of test material in vehicle (if applicable): 25% w/v

No additional data
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Differential weighing
Duration of exposure:
1 h
Concentrations:
5.8 mg/litre during the exposure period. This is an average value over the one hour period.
No. of animals per sex per dose:
5 male and 5 female per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Observed once daily, weighed on initial day and final day.
- Necropsy of survivors performed: yes, Gross pathologic examination revealed nothing remarkable.
- Other examinations performed: Clinical signs, body weight.
Statistics:
None stated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.8 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:
No mortality were observed.
Clinical signs:
other: There were no unusual behavioral signs noted.
Body weight:
All animals gained normal body weight gain.
Gross pathology:
Gross pathologic examination revealed nothing remarkable.
Other findings:
No information provided.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine has an inhalation LC50 greater than 5.8 mg/L.