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Administrative data

Endpoint:
acute toxicity: other routes
Remarks:
intraperitoneal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Principles of method if other than guideline:
5 male and 5 female NMRI mice are administered 700 mg/kg bw test item by a single intraperitoneal injection to the abdominal cavity. The solution comprises 7 % suspension of the test item in 0.5 % aqueous Carboxymethyl cellulose (CMC). Test animals are monitored for mortality and toxic symptoms for 14 days and surviving animals are subjected to gross pathology analysis at necropsy.
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate
EC Number:
216-760-3
EC Name:
Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate
Cas Number:
1658-56-6
Molecular formula:
C20H13N2NaO4S
IUPAC Name:
NA
Test material form:
solid: particulate/powder

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzucht WIGA, Sulzfeld, DE
- Weight at study initiation: males: 24.0 g (mean); females: 22.0 g (mean)
- Fasting period before study: 16 hours
- Diet: ad libitum; Herilan MRH-Kraftfutter (H. Eggersmann, Rinteln/Weser, DE)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
An aqueous solution of 7 % test item suspended in 0.5 % carboxylmethyl cellulose was administered to each animal by intraperitoneal injection to the abdominal cavity.
Doses:
All animals were administered 700 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 24 and 48 hours and 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality and toxic symptoms

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 700 mg/kg bw
Based on:
test mat.
Mortality:
1 hour: no mortality was observed
24 hours: no mortality was observed
48 hours: 3 male and 2 female animals died
7 days: no further mortality was observed
14 days: no further mortality was observed
Clinical signs:
Clinical signs were nonspecific
Gross pathology:
Dead animals: no intra-abdominal test item precipitation or lesions
Sacrificed animals: no intra-abdominal test item precipitation or lesions

Any other information on results incl. tables

Table 1: mortality of test animals administered test item by intraperitoneal injection to the abdominal cavity

Dose (mg/kg bw) Concentration (%) Gender No. animals Number of animals found dead within:
1 hour 24 hours 48 hours 7 days 14 days
700 7 male 5 0 0 3 3 3
700 7 female 5 0 0 2 2 2

Applicant's summary and conclusion

Conclusions:
LD50 (intraperitoneal injection, mouse) was found to be approximately 700 mg/kg bw.
Executive summary:

The acute toxicity of the test item by intraperitoneal injection was evaluated in an experimental study in a limit test without controls. 7 % test item suspended in an aqueous solution of 0.5 % carboxymethyl cellulose was administered to 5 male and 5 female NMRI mice at a concentration of 700 mg/kg bw test item by intraperitoneal injection to the abdominal cavity. Mortality and toxic symptoms were observed at 1, 24 and 48 hours and 7 and 14 days after administration and all animals were subjected to gross pathology analysis at necropsy.

After 1 and 24 hours, no mortality was observed. After 48 hours, 3 male and 2 female animals were found dead. No further mortality occurred within the 14-day study period. Unspecific toxic symptoms observed during the study period. No intra-abdominal test item precipitation or lesions were observed in any test animals at necropsy. The LD50 of the test item was estimated to be approximately 700 mg/kg bw in rats following intraperitoneal injection.