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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 2,1993 to February 24,1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant with international guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of disodium 6-acetamido-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2-sulfonate and sodium 6-acetamido-4-hydroxy-3-{[4(vinylsulfonyl)phenyl]diazenyl}naphthalene-2-sulfonate
Molecular formula:
n.a.
IUPAC Name:
Reaction mass of disodium 6-acetamido-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2-sulfonate and sodium 6-acetamido-4-hydroxy-3-{[4(vinylsulfonyl)phenyl]diazenyl}naphthalene-2-sulfonate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Strain: Hoe: WTSKf(SPF71)
- Age at study initiation:male 8 weeks, females 7 weeks
- Weight at study initiation:
males (x)= 184 g s=±6 g xmin=176 g (-4.4%) xmax= 193 g (+4.8%)
females (x)= 166 g s=±5 g xmin=160 g (-3.7%) xmax= 174 g (+4.8%)
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment.
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate in groups of 5 animals
- Diet: Altromin 1324 rat diet, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at extensive identical conditions)
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55±20%
- Photoperiod: 12 hours cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% suspension, 10 ml/kg bw
PREPARATION OF THE SUBSTANCE
- Remazol-Brillantorange 3R was suspended in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. Stability and homogeneity of the test substance was determined by analytical methods.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 x sex x dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice every day
- Necropsy of survivors performed: yes, at the end of the observation period the animais were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight,organ weights.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred during the whole study.
Clinical signs:
other: No symptoms were observed after application of 2000 mg/kg body weight. Feces and bedding were discoloured reddish at the first day of the study.
Gross pathology:
The animals kilied at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute oral toxicity testing of Reactive Orange 16 in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. No deaths occurred during the whole study.
Executive summary:

Acute oral toxicity testing of Reactive Orange 16 in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. in both male and female animals. After application of 2000 mg/kg b.w. neither deaths nor symptoms occurred. Feces and bedding were discoloured reddish at the first day of the study. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.