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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1981-10-12 to 1981-11-11
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:
1981
Report date:
1981

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:
The test item (25%, diluted in demineralized water) was applied in a dose of 5000 mg/kg by gavage to 10 female Wistar rats after 16 hours and before 2 hours fasting period. The animals were observed for 14 days after application. Symptoms, mortility rate and time of death was examined. Animals which died caused by poisoning were dissected and macroscopic examined. After observation period, survivor animals were killed by CO2, dissected and also macroscopally examined.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
EC Number:
288-950-4
EC Name:
2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
Cas Number:
85940-63-2
Molecular formula:
C22H17N4Na3O13S4
IUPAC Name:
2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonic acid, potassium sodium salt
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Hoe WISKf(SPF71
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: own breeding
- Weight at study initiation: 213 to 230 g
- Fasting period before study: 16 hours
- Housing: in groups in plastic cages on softwood granules
- Diet (e.g. ad libitum): ad libitum, food AL TROMIN 1324 from Altromin GmbH, Lage/Lippe
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
demineralized
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% (25 g/ ad 100 ml)

MAXIMUM DOSE VOLUME APPLIED: 4.6 ml (230 g rat)
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: body weight (weekly), mortality, clinical signs, time of death
Statistics:
Determination of LD50

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
One animal died 120 min after application
Clinical signs:
60 to 120 min after application following symptoms occurred: passivity, trembling, twitching, isolated tonic-clonic cramps, belly-tightened, extended eye lids. On day 2 these clinical signs returned and after 3 days all animals were free of symptoms.
Body weight:
No changes in body weight were observed.
Gross pathology:
In 5 of 9 animals, which have been killed after termination of the study, a spotted kidney were observed. In all other animals there were no macroscopically conspicuous findings.
Other findings:
Faeces and urine were coloured yellow.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to this study, the LD50 in female rats is >5000 mg/gk bw and thus a classification for acute toxicity is not required for the test item.
Executive summary:

In an acute oral toxicity study, 10 female Wistar rats were given a single oral dose of the test item in a concentration of 25%, diluted in demineralized water at a dose of 5000 mg/kg bw and observed for 14 days.

 Oral LD50 = >5000 mg/kg bw

During observation period, one animal died 120 min after treatment. Passivity, trembling, twitching, isolated tonic-clonic cramps, belly-tightened and extended eye lids were observed during the first two days after application. A spotted kidney was observed at necropsy in 5 of the 9 surviving animals. No other macroscopically conspicuous findings were reported.

Based on these results, the test item is of low toxicity based on the LD50 in female Wistar rats and according to CLP criteria classification of acute toxicity is not required.