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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
January to March 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
EC Number:
266-867-4
EC Name:
Sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
Cas Number:
67674-28-6
Molecular formula:
C26H25N5O5S.Na
IUPAC Name:
sodium m-[[4-[[p-[bis(2-hydroxyethyl)amino]phenyl]azo]-1-naphthyl]azo]benzenesulphonate
Test material form:
solid: particulate/powder
Details on test material:
Acid Red 299

Test animals

Species:
rat
Strain:
Wistar
Remarks:
WISW (SPF CPB)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann (Borchen)
- Age at study initiation: male: 9 weeks; female 14 weeks
- Weight at study initiation: male: 166 - 192 g; female: 150 - 176 g
- Fasting period before study: 16h before until 4 hours after application
- Housing: Makroloncage Type III in groups of 5
- Diet (e.g. ad libitum): Altromin R 1324, ad libitum
- Water (e.g. ad libitum): mains water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12

In-life dates: January to March 1983

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: dependent on dose level
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: good water solubility

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
100, 1000, 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of application: multiple observations; during 14 days observation: twice per working day, once on weekend and holiday; weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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 mortality occurred
Clinical signs:
at 1000 and 5000 mg/kg bw diarrhoea was observed 2 h after dosing, which lasted until Day 2.
Body weight:
no effects
Gross pathology:
Male and female animals from dose 310 to 630 mg/kg bw with coloured stomach and small intestine wall. Additionally: stomach without mucosal fold.
Other findings:
no effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute LD50 to male and female rats was determined to be above 5000 mg/kg bw under the conditions of the test.