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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jul - 08 Aug 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000, including the most recent partial revisions
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
448-050-6
EC Name:
-
Cas Number:
444065-11-6
Molecular formula:
C41 H57 N5 O8
IUPAC Name:
2,6-di-tert-butyl-4-methylcyclohexyl 5-{[bis(2-ethoxy-2-oxoethyl)carbamoyl]oxy}-2-(4-tert-butylphenyl)-6-cyano-1H-pyrrolo[1,2-b][1,2,4]triazole-7-carboxylate
Details on test material:
- Name of test material (as cited in study report): UC-141
- Physical state: White powder
- Analytical purity: 99.7% (area %), 98.2% (mass %)
- Lot/batch No.: CE-203
- Expiration date of the lot/batch: 1 Jan 2005
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rat
Strain:
other: Wistar Crl:(WI)BR
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzveld, Germany
- Age at study initiation: Approximately 11 weeks
- Weight at study initiation: 344 g (mean, males) and 227 g (mean, females)
- Fasting period before study: Food was withheld overnight (for a maximum of 20 hours) prior to dosing until 3-4 hours after administration of the test substance
- Housing: Group housing of 3 animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany)
- Diet: Standard pelleted laboratory animal diet (from Altromin (code VRF 1), Lage, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2-24.5
- Humidity (%): 44-83
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: According to OECD 423, if the acute oral toxicity of a substance is expected to be low, a limit test may be performed with the highest dose level of 2000 mg/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Step 1: 3 males
Step 2: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations of mortality were made twice daily; observations of clinical signs were made several times on day 1 and daily thereafter, graded according to a severity scale of 1-4; weighing was performed weekly on day 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: Yes, all gross pathological changes were recorded

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
There was no mortality during the 14-day study period.
Clinical signs:
Uncoordinated movements were noted in all males 2-4 hours after adminstration, lasting until day 2 in 2/3 animals. One male had a hunched posture from 2 hours after dosing until day 3. No clinical signs were observed in the females.
Body weight:
There were no effects on body weight.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Mortality and clinical signs

Dose
[mg/kg bw]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Males

2000

0/3/3

1 h - 3 days

-

0

LD50 > 2000 mg/kg bw

Females

2000

0/0/3

-

-

0

LD50 > 2000 mg/kg bw

                                                                                           

* first number = number of dead animals                                 

 second number = number of animals with clinical signs         

 third number = number of animals used                               

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified