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Diss Factsheets

Administrative data

Description of key information

Reactive Orange 72/78 is practically non-toxic. The LD50 for oral administration is 8377 mg/kg body weight, the LD50 for dermal application withthe structural analogue 01 lies above 2000 mg/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 20,1973 to January 4,1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 85 g
- Fasting period before study:16 hours before gavage application and 2 hours after
- Housing: in macrolon cages on soft wood granulate
- Diet : Altromin 1324 rat diet, ad libitum
- Water : ad libitum

Start of study: December 20, 1973
End of study: January 04, 1974
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%

Doses:
6300, 8000, 10000, 12500 mg/kg bw
No. of animals per sex per dose:
10 female rats per dose level
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: multiple times on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes
Statistics:
The LD50 and the limits of confidence were established in female animals on the basis of the Iethality rates by probit analysis.
(method of LINDNER and WEBER, and method of CAVALLI-SFORZA, programs supplied by Prakt. Mathematik, Hoechst Aktiengesellschaft)
Sex:
female
Dose descriptor:
LD50
Effect level:
8 377 mg/kg bw
Based on:
test mat.
95% CL:
7 741 - 9 065
Sex:
female
Dose descriptor:
LD100
Effect level:
12 500 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD0
Effect level:
6 300 mg/kg bw
Based on:
test mat.
Mortality:
8000 mg/kg: 4 of 10 rats
10000 mg/kg: 9 of 10 rats
12500 mg/kg: 10 of 10 rat
Clinical signs:
other: prone position and disorders of balance
Gross pathology:
orange discolouration of organs and connective tissue
Other findings:
The dye was in the feces and urine.

Doses
mg/kg
concentrations in % Mortality
6300 25 0 of 10 rats
8000 25 4 of 10 rats
10000 25 9 of 10 rats
12500 25 10 of 10 rats
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results obtained in this study the median lethal dose value (LD50) of Remazol Goldorange 3G was calculated by probit analysis for the female Wistar rat to be 8377 mg/kg body weight.
Executive summary:
Remazol Goldorange 3G was tested for acute toxic effects by oral administration in female Wistar rats only, as male animals did not show a higher sensitivity to the test substance. Lethality occurred up to day 3 of the study at 8000, 10000, and 12500 mg/kg bw. The animals showed prone position and disorders of balance. Development of body weight was not impaired in the surviving animals. The test substance was excreted with feces and urine. Necropsy of the deceased animals revealed orange discolouration of organs and connective tissue. The acute oral toxicity testing of Remazol Goldorange 3G in the female Wistar rat yielded a median lethal dose (LD50) of 8377 mg/kg body weight. The classification by “Handbook of Toxicology” describes the test dye as non toxic
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 377 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 15,1985 to July 29 ,1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation:male 7 weeks old , females 10 weeks old
- Weight at study initiation:male 184-200 g , female 189-219
- Fasting period before study: NA
- Housing: individually housed in air-conditioned rooms in Makrolon cages (type 3) on softwood pellets
- Diet : altromin 1324, ad libitum
- Water : tap water in plastic bottle, ad libitum
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ±°C
- Humidity (%):50 ± 20%
- Air changes (per hr):fully air condition
- Photoperiod (hrs dark / hrs light):12 hours cycle dark/light
Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure:30 cm^2
- % coverage: 6 x 8 cm
- Type of wrap if used:
aluminum-foil (6 x 8 cm) and one elastic. The elastic is used to fix around the body of the animal the aluminium foil (Elastoplast, 8 cm).

REMOVAL OF TEST SUBSTANCE
- Washing :yes

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Reactive Orange 64 258 FW F-ratio was 1.0 g + 0.50 ml moistened with isotonic saline solution (sterile, pyrogen-free, supplied by Fresenius AG).
- For solids, paste formed: yes





Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals x sex x dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:every weeks
- Necropsy of survivors performed: yes
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:
test mat.
Mortality:
no mortality observed
Clinical signs:
other: no clinical signs observed
Gross pathology:
no adverse effects
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal medium lethal dose (LD50) was determined to lie above 2000 mg/kg body weight.
Executive summary:

The test substance was examined for acute dermal toxicity in male and female Wistar rats at the limit dose of 2000 mg/kg body weight. After administration of 2000 mg/kg bw no deaths or clinical signs of toxicity were observed.The dermal medium lethal dose (LD50) was determined to lie above 2000 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

The acute oral toxicity testing of Reactive Orange 72/78 in the female Wistar rat was carried out at dose levels of 6300, 8000, 10000, and 12000 mg/kg body weight. Male animals did not show a higher sensitivity to the test substance. Lethality occurred up to day 3 of the study. The animals showed prone position and disorders of balance. The test substance was excreted with feces and urine. Development of body weight was not impaired. Necropsy of the deceased animals revealed orange discolouration of organs and connective tissue.

Based on the results obtained in this study the median lethal dose value (LD50) of Reactive Orange 72/78 was calculated by probit analysis for the female Wistar rat to be 8377 mg/kg body weight.

The test substance was examined for acute dermal toxicity in male and female Wistar rats at the limit dose of 2000 mg/kg body weight. After administration of 2000 mg/kg bw no deaths or clinical signs of toxicity were observed.The dermal medium lethal dose (LD50) was determined to lie above 2000 mg/kg body weight.

Justification for classification or non-classification