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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
June 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
A single dose was administered to rats by oral gavage and observed for mortality for 14 days observation period.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt
EC Number:
228-058-4
EC Name:
Hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt
Cas Number:
6104-58-1
Molecular formula:
C47H49N3O7S2.Na
IUPAC Name:
hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Appearance: Blue colouring
Physical state: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals:
Healthy Sprague-Dawley derived rats, bred on the premises, aged 5 - 6 weeks, having an average body weight of 167 g (Males) and 125 g (Females).

Husbandry:
Rats were caged singly and kept in a room maintained at a temperature of 21 °C (+/-2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Administration of Compound:
A 25 % w/v suspension of the compound in a 2 % aqueous solution of Carboxymethyl Cellulose was administered as a single dose by gavage to rats which had been fasted for 10 hours, at a dose rate of 20ml/kg. (Equivalent to 5 g/kg compound).
Doses:
20 ml/kg (equivalent to 5 g/kg compound).
No. of animals per sex per dose:
Ten rats (5 males and 5 females).
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, organ examinations.
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the 14 days observation period.
Clinical signs:
other: No clinical symptoms were recorded during the 14 days observation period.
Gross pathology:
At autopsy no changes in organs or tissues causes by the administration of the test compound were seen.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of FAT 20085/A in rats (both sexes) is >5000 mg/kg body weight.
Executive summary:

The acute oral toxicity of FAT 20085/A was evaluated in a study conducted according to the methodology similar to OECD Guideline 401. In this study, the test article FAT 20085/A was administered as a single dose by oral gavage to rats of both sexes, at a dose of 5000 mg/kg bw in a solution of Carboxymethyl Cellulose. No deaths or clinical signs were observed during the 14-days observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. Hence, the acute oral toxicity (LD50) of FAT 20085/A in rats of both sexes, observed over a period of 14 days, was estimated to be >5000 mg/kg bw.