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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
year 1981
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
EC Number:
233-311-7
EC Name:
Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
Cas Number:
10114-47-3
Molecular formula:
C28H20N4O6S4.2Na
IUPAC Name:
disodium 2,2'-(diazene-1,2-diyldi-4,1-phenylene)bis(6-methyl-1,3-benzothiazole-7-sulfonate)
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: orange powder- Batch No.: 31/94- Prevailing particle size: 2 - 4 µm

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: breeding farm Velaz Praha- Females (if applicable) nulliparous and non-pregnant: yes- Age at study initiation: 8 weeks- Weight at study initiation: 177.2 g (male, average), 173.2 (female, average)- Diet (e.g. ad libitum): granulated feed mixture ALTROMIN 1320 12 g/animal/day- Water (e.g. ad libitum): tap waster ad libitum- Acclimation period: 1 week ENVIRONMENTAL CONDITIONS - Temperature: 22 ± 3°C - Humidity: 40 - 60 % - Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
head only
Vehicle:
air
Remark on MMAD/GSD:
Particle size distribution:1 - 4 µm: 76.29 %4 - 10 µm: 17.29 %10 - 20 µm: 5.20 %above 20 µm: 1.21 %
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION - Method of holding animals in test chamber: head only - Source and rate of air: 10 l/min - System of generating particulates/aerosols: Vright Dust Feed Unit MK2, GA 4170, L. Adams ltd., London - Temperature, humidity, pressure in air chamber: temperature 22°C, humidity 55 %, negative pressure 98 Pa TEST ATMOSPHERE - Brief description of analytical method used: Samples of the atmosphere from the inhalation chamber were collected at a rate 4 l/min; 10 liters of air was taken in total. The collected air passed through the filter cartridge and the concentration of the test substance was determined gravimetrically. VEHICLE - Vehicle: air - Concentration of test material in vehicle (if applicable): 4.97 mg/l
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
4.97 mg/l
No. of animals per sex per dose:
5 males / 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: observation 1 and 2 hours after ending of the exposure, then once a day; body weight on day 0, 7 and 14 - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
not observed
Clinical signs:
other: During exposure: orange discharge from the nasal cavity, motor disorders of the body, limbs or tail have not been observedPost exposure period:- 0, 60 and 120 min: piloerection, orange discharge from the nasal cavity, regular breathing 110 - 120 per minut
Body weight:
Average body weight: Treated group:- day 0: 177.2 g (M), 173.2 g (F)- day 7: 181.6 g (M), 175.2 g (F)- day 14: 186.8 g (M), 186.8 g (F) Control group:- day 0: 172.7 g (M), 166.7 g (F)- day 7: 173.3 g (M), 198.0 g (F)- day 14: 188.3 g (M), 208.6 g (F)
Gross pathology:
Pathological examination did not reveal any general or focal pathology changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
For Reactive Orange 13, a limit test for acute inhalation toxicity was performed. The test was performed according to the OECD TG 403 methodology. The experimental animals (rats) were exposed to inhalation of the test substance powder in air for 4 hours in a “head-only” inhalation chamber. Actual concentrations of the test substance were determined gravimetrically. Prior to exposure, the particle size was measured microscopically; majority size was in the range of 1-4 μm.During the exposure and during the 14-day observation period there was no death of the test animals.Clinical disorders of the health of the test animals may be considered as a consequence of mechanical irritation of the upper respiratory tract.The results of the limit test did not reveal any adverse effect on the health of the experimental animals.
Executive summary:

For Reactive Orange 13, a limit test for acute inhalation toxicity was performed. The test was performed according to the OECD TG 403 methodology. The experimental animals (rats) were exposed to inhalation of the test substance powder in air for 4 hours in a “head-only” inhalation chamber. Actual concentrations of the test substance were determined gravimetrically. Prior to exposure, the particle size was measured microscopically; majority size was in the range of 1-4 μm.

During the exposure and during the 14-day observation period there was no death of the test animals.

Clinical disorders of the health of the test animals may be considered as a consequence of mechanical irritation of the upper respiratory tract.

Pathological examination revealed the penetration of the test substance into the lung tissue in two males. Mild pulmonary congestion probably was caused due to circulation changes in the euthanasia of animals.