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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug - Sep 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
EC Number:
278-137-2
EC Name:
Sodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
Cas Number:
75214-69-6
Molecular formula:
C36H34CrN10NaO8S2
IUPAC Name:
hydroxylamine
Test material form:
solid: granular

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 (male) - 14 (female) weeks
- Weight at study initiation: 166-181 g (male) and 150-169 g (female)
- Females: nulliparous and not pregnant
- Fasting period before study: 16 h
- Housing: Makrolon type 3 cage with softwood bedding
- Diet (e.g. ad libitum): Altromin®1324 Pellets ad lib. 4 h after dosing
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Application volume: 20 mL/kg bw
Doses:
5000 mg/kg bw
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: four times during day 1, twice per day during days 2-15 (once per day during weekend)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behaviour

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occured
Clinical signs:
No symptoms
Body weight:
No effect on body weight gain
Gross pathology:
No macroscopic findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 oral was determined to be >5000 mg/kg in female/male rats. The substance does not meet the classification criteria according to the CLP Regulation.