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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 23, 1986 to September 23, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
EC Number:
401-560-2
EC Name:
Lithium sodium hydrogen 4-amino-6-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
Cas Number:
108624-00-6
Molecular formula:
C28H(21-x-y)ClF2Li(x)N8Na(y)O16S5
IUPAC Name:
Lithium sodium hydrogen-4-amino-6-(5-(5-chloro-2,6-difluoropyrimidine-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
Reactive Blue FC 05717

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 33178 Borchen, SPF breeding colony.
- Age at study initiation: 9 (males) - 14 (females) weeks
- Average body weight at treatment: Males: 171 g; Females: 176 g (less than 20% deviation to average)
- Housing: Macrolon cages (i.e., type 3) on soft wood granulate
- Diet: Altromin 1324, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 d
- Animal identification: Fur marking and cage numbering
- Withdrawal of food: From about 16 h before to 3-4 h after treatment

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C
- Humidity: 50±10%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: June 10, 1986 to June 24, 1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
3,100 and 5,000 mg/kg bw
No. of animals per sex per dose:
Five/sex/dose
Control animals:
no
Details on study design:
Test procedure

- The prepared test substance was administered by gavage to fasted animals at the stated dosage. The observation period following treatment lasted for 14 d.

- Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once.

- The animals were weighed before treatment, after Week 1 and at the end of Week 2.

- At the end of the observation period the animals were killed using diethylether, dissected and examined for macroscopically visible changes.

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:
There was no mortality at 3,100 mg/kg bw. One male (Day 2) and one female (8 h) died at 5,000 mg/kg bw.
Clinical signs:
other: Degradation of general condition, rough fur.
Gross pathology:
Blue discoloration of stomach mucous and abdominal organs were seen in the animals which died during the course of the study.
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the acute oral LD50 of the test substance to the rats was found to be >5,000 mg/kg bw in rats.
Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in Wistar rats according to EU Method B.1, in compliance with GLP. Groups of five female and five male fasted rats received a single oral (gavage) dose of 3100 or 5000 mg/kg bw. A suspension of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw. No mortality occurred at 3100 mg/kg bw. One male (Day 2) and one female (8 h) died at 5000 mg/kg bw. Blue discoloration of stomach mucous and abdominal organs was seen in the animals which died in the course of the study. The animals killed at the end of the observation period showed no macroscopically visible changes. Clinical signs after administration of the test substance included degradation of the general condition and rough fur. Under the study conditions, the oral LD50 of the test substance was found to be >5000 mg/kg bw in rats (Ramm, 1986a).