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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-guideline study
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)
EC Number:
233-357-8
EC Name:
Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)
Cas Number:
10127-27-2
Molecular formula:
C16H11CrN5O8S.Na
IUPAC Name:
sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Remarks:
Tif. RAI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy breeding colony, SPF-breed
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: during one night before starting the treatment
- Housing: Macrolon cages type 3, 5 animals per cage
- Diet: NAFA rat diet, Gossau SG, ad libitum
- Water. water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 1°C
- Humidity: ca 50 %

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
PEG 400
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 % suspension
Doses:
4640, 6000 and 7750 mg/kg bw
No. of animals per sex per dose:
5 males
5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 700 mg/kg bw
Based on:
test mat.
Mortality:
one male animal of the high dose group died within 24 h
Clinical signs:
within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased.
The surviving animals had recovered within 7 to 8 days.
Gross pathology:
No gross organ changes were seen in dead and killed animals at scheduled necropsy.

Any other information on results incl. tables

Table 1: individual results

[mg/kg bw]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1 hour

24 hours

48 hours

7 days

14 days

 

m

f

m

f

m

f

m

f

m

f

m

f

4640

5

5

0

0

0

0

0

0

0

0

0

0

6000

5

5

0

0

0

0

0

0

0

0

0

0

7750

5

5

0

0

1

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Regulation (EC) 1272/2008
Conclusions:
4640, 6000 and 7750 mg test item per kg bw were administered in male and female rats. During the 14 days observation period 1 male died, resulting in a LD50 > 7750 mg/kg bw.
Executive summary:

Male and female rats were subjected to test acute oral toxicity according to a protocol similar to OECD TG 401. The test item was administered at dose levels of 4640, 6000 and 7750 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period one male died and there were no ab normalities found in necropsy, thus leading to an LD50 > 7750 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.

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