Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

Endpoint summary

Description of key information

Oral route:
The LD50 of Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is greater than 5000 mg/kg (Biosearch, 1979). 
Inhalation route:
The LD50 of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is greater than 5.8 mg/l (Biosearch, 1979). 
Dermal route:
Dermal exposure to bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered unlikely, therefore, this endpoint is waived.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23 January to 6 June 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.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Principles of method if other than guideline:

One group of ten (5 male & 5 female) albino rats of the Sherman-Wistar Strain were employed in this study. Each animal was weighed and dosed by direct administration of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine into the stomach by means of a syringe and dosing needle. Following 14 days observation period during which time the rats were observed for signs of toxicity and mortalities.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 gm
- Fasting period before study: 24 hours
- Water (e.g. ad libitum): ad libitum

no additional data

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/v

No additional data

Doses:

5.0 gm/kg

No. of animals per sex per dose:

5 males/5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily. The body weight in the preliminary study was recorded immediately.
-Necropsy of survivors performed: yes, Gross pathologic examination revealed nothing remarkable.
-Other examinations performed: clinical signs, body weight

Statistics:

None stated

Sex:

male/female

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed.

Clinical signs:

other: There were no unusual behvioral signs noted.

Gross pathology:

Gross pathologic examination revealed nothing remarkable.

Other findings:

No information provided

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 when studied in male and female albino rats has an acute oral LD50 greater than 5.0 gm/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

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.

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

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

None stated.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

1

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral route

In a study conducted similar or equivalent to OECD 420 (pre-dates GLP), male and female albino rats were exposed to bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine. (Biosearch, 1979). In this study the LD50 of the substance is >5,000 mg/kg (Biosearch, 1979).

Inhalation route

In a study conducted similar or equivalent to OECD 403 (pre-dates GLP), male and female were exposure to Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine via aerosol (Biosearch, 1979). In this study the LC50 of the substance is >5.8 mg/L (Biosearch, 1979).

Dermal route

According to Column 2 of Annex VIII of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 1902/2006 regulation, a dermal toxicity study does not need to be conducted if exposure of humans via skin contact unikely. Dermal exposure to bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered unlikely, therefore, this endpoint is waived.

In addition oral and inhalation toxicity studies are available.

Justification for selection of acute toxicity – oral endpoint
Key study, equivalent or similar to OECD 420, pre-dates GLP.

Justification for selection of acute toxicity – inhalation endpoint
Key study, equivalent or similar to OECD 403, pre-dates GLP.

Justification for classification or non-classification

Acute toxicity - Oral:

The acute oral LD50 of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is >5,000 mg/kg in rats, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1 bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amineis not classified for Acute Oral Toxicity.

 

Acute toxicity - Inhalation:

The acute inhalation LC50 of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is > 5.8 mg/L in rat, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is not classified for acute inhalation toxicity.