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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Justification for type of information:
Data is from study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The objective of the study was to assess the dermal toxicity of test chemical after single dose application by dermal route in rats and an observation period of 14 days.
GLP compliance:
yes
Test type:
standard acute 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:
C28-H43-N
IUPAC Name:
4-(2,4,4-trimethylpentan-2-yl)-N-[4-(2,4,4-trimethylpentan-2-yl)phenyl]aniline
Details on test material:
Identification : Bis(4-(1,1,3,3-tetramethylbutyl)phenyl amine
Appearance : Off White Solid
Batch number : Lot. 03/31
CAS No. : 15721-78-5
AI Content : 98.72%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species :Rat (Rattus norvegicus)
Strain :Wistar
Sex :Male and Female
Number of Animals :10 (Five per sex)
Supplier/Source :In-House
Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant
Body weight of animals:male:minimum: 234 g and Maximum: 282 g (Prior to Treatment)Female: Minimum: 237 g and Maximum: 253 g
Acclimatisation :All animals were acclimatized to the test conditions for 8 days prior to test item application

Randomization :Animals were selected manually. No computer generated randomization program was used.
Diet :All animals were provided conventional laboratory rodent diet ad libitum. Batch No 400010 and 400011.
Bedding :All cages were provided with corn cobs
Water :Aqua guard filtered tap water was provided ad libitum via drinking bottles.
Husbandry :The animals were housed individually in polycarbonate cages.
Room Sanitation :The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
Cages and water bottle:All the cages and water bottles were changed at least twice every week

Temperature :Minimum: 19.60 °C Maximum: 21.40 °C
Relative humidity :Minimum: 47.40% Maximum: 58.60%
Light-dark-rhythm:12 hour light and 12 hour dark
Air Changes :More than 12 changes per hour

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Approximately 24 h prior to treatment, the fur of dorsal area of the trunk (greater than 10% body surface area) of rats was clipped by using clipper
Duration of exposure:
24-hour
The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with an amount of test item moistened with 0.2 ml distilled water. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item. At the end of the exposure period, residual test item was removed by using distilled water. The animals were dosed between 13:01 to 13:09
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male & 5 female
Control animals:
yes
Statistics:
not specified

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period
Clinical signs:
other: At 2000 mg/kg, all the animals were observed normal throughout the experimental period
Gross pathology:
The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality
Other findings:
not specified

Any other information on results incl. tables

TABLES

Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)

 

Dose:2000 mg/ kg bodyweight                                                                                                         

Animal No.

Sex

Body Weight (gram)

Body Weight Change (%)

Day 0

Day 7

Day 14

Day 0-7

Day 0-14

1

Male

282

290

301

2.84

6.74

2

268

273

283

1.87

5.60

3

257

260

271

1.17

5.45

4

263

266

287

1.14

9.13

5

234

244

254

4.27

8.55

6

Female

253

255

259

0.79

2.37

7

247

249

253

0.81

2.43

8

237

239

243

0.84

2.53

9

243

246

251

1.23

3.29

10

239

242

247

1.26

3.35


Table 2: Individual Animal Clinical Signs and Symptoms

 

Dose:2000 mg/kg body weight

Animal

No.

Sex

Hour(s) - Day 0

Day

1

2

3

4

1

2

3

4

5

6

7

1

Male

1

1

1

1

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

1

1

1

1

3

1

1

1

1

1

1

1

1

1

1

1

4

1

1

1

1

1

1

1

1

1

1

1

5

1

1

1

1

1

1

1

1

1

1

1

6

Female

1

1

1

1

1

1

1

1

1

1

1

7

1

1

1

1

1

1

1

1

1

1

1

8

1

1

1

1

1

1

1

1

1

1

1

9

1

1

1

1

1

1

1

1

1

1

1

10

1

1

1

1

1

1

1

1

1

1

1

 

Animal

No.

Sex

Day

8

9

10

11

12

13

14

1

Male

1

1

1

1

1

1

1

2

1

1

1

1

1

1

1

3

1

1

1

1

1

1

1

4

1

1

1

1

1

1

1

5

1

1

1

1

1

1

1

6

Female

1

1

1

1

1

1

1

7

1

1

1

1

1

1

1

8

1

1

1

1

1

1

1

9

1

1

1

1

1

1

1

10

1

1

1

1

1

1

1

Key: 1 = Normal


Table 3: Individual Animal Mortality Record

 

Dose:2000 mg/kg body weight

       Animal No.

Sex

Days of Observation (0 to 14)

Morning Observations

Evening Observations

1

Male

No mortality and morbidity

No mortality and morbidity

2

No mortality and morbidity

No mortality and morbidity

3

No mortality and morbidity

No mortality and morbidity

4

No mortality and morbidity

No mortality and morbidity

5

No mortality and morbidity

No mortality and morbidity

6

Female

No mortality and morbidity

No mortality and morbidity

7

No mortality and morbidity

No mortality and morbidity

8

No mortality and morbidity

No mortality and morbidity

9

No mortality and morbidity

No mortality and morbidity

10

No mortality and morbidity

No mortality and morbidity


Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)

 

Dose:2000 mg/kg body weight

Sex

Body Weight (gram)

Body Weight Changes (%)

Day 0

Day 7

Day 14

Day 0-7

Day 0-14

Male

Mean

260.80

266.60

279.20

2.26

7.09

SD

17.60

16.91

17.70

1.32

1.68

n

5

5

5

5

5

Female

Mean

243.80

246.20

250.60

0.99

2.79

SD

6.42

6.22

6.07

0.24

0.48

n

5

5

5

5

5

Keys:SD= Standard deviation, n = Number of animals

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight.
Executive summary:

Acute Dermal Toxicity Study of test chemical was conducted in Wistar Rats.This study was performed as per OECD No.402.Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.

On test day 0, an amount of testitem moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area.This porous gauze dressing was covered with a non-irritating tape.After the 24-hour application period, the dressings were removed and theskin was gently wiped with distilled water.The skin reactions were assessed.

The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period. At 2000 mg/kg, all the animals were normal throughout the experimental period.Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Thus considering the CLP Criteria for classification of the substance, it is concluded that test chemical could no texhibit acute toxicity to rat by the dermal route.