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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class method
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
Details on test material:
- Name of test material (as cited in study report): RA 3643 BXA
- Substance type: white powder
- Physical state: solid
- Expiration date of the lot/batch: January 4, 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
5 males + 5 females/group
- Source: Charles River Italia SpA Calco (COMO) Italy
- Age at study initiation: 7-9 weeks
- Weight at study initiation: Males: 225-250g Famales: 200-225g
- Diet (e.g. ad libitum): GLP 4 RF 21 top certificate pelletted diet; the content were crude protein (18.5%), crude fat (3%), crude fiber (6%), crude ash (7%). The diet was supplemented with vitamins and trace elements. The diet was available ad libitum.
- Water (e.g. ad libitum): from the municipal water main system. Ad libitum.
- Acclimation period: five days before the start of the test

ENVIRONMENTAL CONDITIONS
5 animals/sex/cage in T11C air conditioned room
- Temperature (°C): 22°C +/- 2
- Humidity (%): 55+/- 10
- Air changes (per hr): about 20/hour filtered on HEPA 99.97%
- Photoperiod (hrs dark / hrs light): 12 hour cycle (7am-7pm)
-Cage size: grill cages 40.5x38.5x18h cm with stainless steel feeder.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose water solution
Doses:
2000 mg/Kg
No. of animals per sex per dose:
5 male and 5 female 2000 mg/kg
Control animals:
yes
Details on study design:
- Observation period: 14 days after the administration
- Observation of clinical signs and mortality: at 30 minutes, 2, 4 and 6 hours on the first day after the administration and the twice a day up to termination of the observation period

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animals died during the observation period.
Clinical signs:
other: No clinical signs during the 14 day observation period.
Gross pathology:
On all surviving animals killed by excision of the femoral arteries, after i.p. overdosage anesthesia with 5% sodium pentobarbital, at the end of the observation period. No appreciable macroscopic findings were evident in any treated rat.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test article, when administered to rats as a single dose by oral route, was higher than 2000 mg/kg. The substance is to be considered not toxic.