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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Based on the results obtained in an acute oral study the LD(0) of Macrolex Fluoreszenz Rot G for the male and female Wistar rat is greater than 2000 mg/kg body weight.

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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
Name: Macrolex Fluoreszenz Rot G

Chemical name: 2H-1-Benzopyran-4-carbonitri le,3-(2-benzothiazolyt-7-(oliethylamino)-2-oxo-

CAS-Number: 70546-25-7

Molecular formula: C12H11N3O2S

Molecular weight: 375 g/mol

Specific gravity: 0.24-0.29 kg/I

Certificate of analysis dated June 24, 1996

Purity: 100 % technical pure
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age at the start of the study: male animals approximately 7 weeks female animals approximately 8 weeks

Body weights: males: mean = 179 g; females:mean = 167 g
Animal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) an soft wood granulate in groups of 5


Room temperature: 22 ± 3°c
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily at least one day
Food: ssniff® R/M-H (V 1534), ad libitum

Withdrawal of food: from about 16 hours before to 3 - 4 hours after treatment

Water: tap water in plastic bottles, ad libitum

Animal identification: fur marking with KMnO4 and cage numbering
Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Details on oral exposure:
Macrolex Fluoreszenz Rot G was suspended in the stated concentration in sesame oil and distributed homogeneously by means of a magnetic stirrer.

The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males; 5 females
Control animals:
no
Statistics:
not applicable
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
no
Clinical signs:
other: The following clinical signs were observed after the administration of Macrolex Fluoreszenz Rot G: irregular respiration, stilted and uncoordinated gait, squatting posture, diarrhea and dark-colored feces.
Gross pathology:
The animals killed at the end of the observation period showed no macroscopically visible changes.
Interpretation of results:
GHS criteria not met
Executive summary:

Based on the results obtained in this study the median lethal dose value (LD50) of Macrolex Fluoreszenz Rot G for the male and female Wistar rat is greater than 2000 mg/kg body weight. No aniamls died at 2000 mg/kg, consequently this dose is considered to be the LD(0).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
the substance is not toxic after acute oral dosing and not irritating to skin or eye. Consequently it is concluded that it is very likely that he substance is not toxic after dermal exosure.

Additional information

Classification is not warrated because. Based on the results obtained in an acute oral study the LD(0) of Macrolex Fluoreszenz Rot G for the male and female Wistar rat is greater than 2000 mg/kg body weight. The substance is not not irritating to skin or eye. Consequently it is concluded that it is very likely that the substance is not toxic after dermal exosure.

Justification for classification or non-classification