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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Hazieton Manual of Standard Operating Procedures
Deviations:
not specified
GLP compliance:
no
Remarks:
Study conducted before 1981
Limit test:
no

Test material

1
Reference substance name:
Acid Blue 158
IUPAC Name:
Acid Blue 158

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Ltd.
- Weight at study initiation: 20 - 32 g.
- Fasting period before study: (for 18-20 hours before treatment)
- Housing: All animals were housed in a single air-conditioned room. They were caged in groups of five by sex in solid floor polypropylene boxes furnished with sterilised sawdust. Sawdust was replaced twice per week. Sawdust was removed during the overnight fast and replaced after dosing.
- Diet: free access to mains water and food (Rat and Mouse No. 1 Expanded Die t, B.P. Nutrition (U.K.)
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 10 %
- Photoperiod (hrs dark / hrs light): exposed to natural lighting conditions.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
First experiment: 2000 mg/kg bw
Second experiment: 215, 316, 464,681,1000,1470 mg/kg b.w
No. of animals per sex per dose:
6 animals per sex per doses
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: Animals were observed for overt toxicity and mortality at 15 minutes, 1, 2 and 4 hours after treatment and subsequently once daily for 14
- Frequency of weighing: Body weights of survivors were recorded 14 days after treatment.
- Necropsy of survivors performed: no
Statistics:
Statistical Method for Biological Assay, 2nd Edition, London: Charles Griffin).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 380 mg/kg bw
Based on:
test mat.
95% CL:
> 310 - < 460
Remarks on result:
other: 95 % CL
Mortality:
All deaths occurred within 24 - 48 hours of treatment.
Clinical signs:
No signs of overt toxicity ware apparent during the 14 day observation period
Body weight:
All surviving animals showed normal body weight gains during the 14 day observation period.

Any other information on results incl. tables

Treatment schedule

Dose group  Dose level (mg/kg) Solution concentrations (mg/ml) Treatment volume (ml/kg)
Approximate LD50 1 2000 100 20
Formal LD 50 2 215 10.75 20
3 316 15.8 20
4 464 23.2 20
5 681 34.05 20
6 1000 50 20
7 1470 73.5 20

Applicant's summary and conclusion

Conclusions:
LD50(male/female) = 380 mg/kg bw
Executive summary:

The test was conducted according to a method described in Hazieton Manual of Standard Operating Procedures. during the test. As preliminary study five male and five female mice of the CDI strain were treated with a single intraperitoneal dose of test article at a dose level of 2000 mg/kg. All animals died within 24 hours of treatment. Following the initial study other 10 mice (5 male and 5 female)of the CDI strain were treated with a single intraperitoneal dose of test article within the range 216 - 1470 mg/kg. Deaths occurred in all the concentration tested

The acute intraperitoneal LD50 of test article, calculated by Finney's Probit Method was found to be 380 mg/kg with 95 % confidential limits of 310 - 460 mg/kg.,