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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:
sub-chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct-Dec 2022
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
GLP compliance:
yes
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
421-450-8
EC Name:
-
Cas Number:
154702-15-5
Molecular formula:
C44H59N7O5
IUPAC Name:
2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on exposure:
From D0 to D27 , dose application: 4 layers of porous gauze were placed on a layer of non-irritating tape.
Finally, the patch was placed on the elastic bandage. For the treatment group and satellite group, the moistened test item was evenly put on the gauze, then be applied to the area where the hair was removed. Finally, the patch was applied to the area where the hair was removed.
Exposure time was 6 h a day, lasted for 28 days.
At the end of 6 hours (+ 10min) exposure period, the residual test item was removed by water.
Duration of treatment / exposure:
Each rat in treatment group and satellite group was continuously repeatedly dosed at 1000mg/kg body weight per day for 28 days.
Frequency of treatment:
Exposure time was 6 h a day, lasted for 28 days.
Doses / concentrations
Dose / conc.:
1 000 mg/kg bw/day
No. of animals per sex per dose:
5 animals / sex / dose
Control animals:
yes
Details on study design:
The dose administration was calculated weekly on D0, D7, D14 and D21

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily from D- 1 to D27 in control group, satellite group and treatment group, while kept for a further 14 days for satellite group without dose administration

DETAILED CLINICAL OBSERVATIONS: No data

DERMAL IRRITATION (if dermal study): No

BODY WEIGHT: Yes
- Time schedule for examinations: weekly and before euthanasia

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: on D28 for animals in control group and treatment group, while operated on D42 for animals in satellite group in the recovery period
- Anaesthetic used for blood collection: Yes (5 0 mg/ kg Zoletil 50)
- Animals fasted: Yes
- How many animals: 30
- Parameters checked: Hematology Examination / Coagulation- related Examination / Biochemical Examination

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on D28 for animals in control group and treatment group, while operated on D42 for animals in satellite group in the recovery period
- Animals fasted: Yes
- How many animals: 30

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes (the external surface of the body, all orifices, and the cranial, thoracic, abdominal cavities and their contents.)

HISTOPATHOLOGY: Yes (the normal and treated skin, liver and kidney after 2 8 days exposure period)
Statistics:
Data of body weights and body weight changes, food consumption, organ weights and organ coefficients, and clinical examinations were analyzed by T-test in software Excel 20 1 3.
P- value of body weights and body weight changes, and food consumption from D0 to D2 8 were compared between indexes in control group and that in treatment and satellite group.
P- value of clinical examination, organ weights and organ coefficients on D28 were compared between indexes in control group and that in treatment group.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
effects observed, non-treatment-related
Clinical biochemistry findings:
effects observed, non-treatment-related
Endocrine findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
effects observed, non-treatment-related
Histopathological findings: neoplastic:
not examined
Other effects:
effects observed, non-treatment-related
Description (incidence and severity):
Coagulation-related Examination:
After 28 days exposure period, data showed that APTT of female rats decreased significantly and kept that level on D42. The change value of APTT was about 1 sec which is considered slightly and physiological caused by slightly increased PLT, rather than pathological.
After a further 14 days recovery period, PT and INR decreased significantly (P value＜0.05) but did not show any significant change, so it was considered to be related to the age of animals.
The test item did not cause coagulation disorder.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Remarks on result:
other: no test item related functional and organic damages of visceral lesions were observed.

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Based on the results of the study, percutaneous repeated dose of 1000 mg/ kg Diethylhexyl Butamido Triazone for 28 days did not cause mortality and toxic effects and no test item related functional and organic damages of visceral lesions were observed.
Executive summary:

No toxic effect of percutaneous repeated exposure to a dose of 1000 mg/kg bw of Diethylhexyl Butamido Triazone during 28 days has been observed.