Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
May 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Cycle dark/light 14 hours
GLP compliance:
no
Remarks:
pre GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Acid Blue 025:1
IUPAC Name:
Acid Blue 025:1
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
other: Tif: RAIf
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy Basle, Toxicology/Pathology PH 2.634/CP/gk
- Weight at study initiation: Mean initial body weight: from 80 to 86 grams
- Housing: group of 5 into Macrolon cages (Type 3)
- Diet (e.g. ad libitum): ad libitum Pellets n. 890 Nafag Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±1 °C
- Humidity (%): 55 ±5 %
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %, 30 %, 25 %
Doses:
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Pre-mortem:
Dose 1000 mg/kg bw: after 30 minutes hyperreflexia
Dose 3000 mg/kg bw : ditto, after 15 minutes irregular respiration reduction in spontaneous motility, muscolar hypotonia.
Dose 10000 mg/kg bw : ditto stiff movements, piloerection.
Dose 15000 mg/kg bw : ditto laboured respiration, ataxia.
Body weight:
Dose 1000 mg/kg bw : 86 g (pre-test), 182 g (on day 15 of test)
Dose 3000 mg/kg bw : 84 g (pre-test), 179 g (on day 15 of test)
Dose 10000 mg/kg bw : 80 g (pre-test), 175 g (on day 15 of test)
Dose 15000 mg/kg bw :82 g (pre-test), 177 g (on day 15 of test)
Gross pathology:
Dose 1000 mg/kg bw : no gross organ changes observed
Other findings:
Post-mortem:
Dose 1000 mg/kg bw: no gross organ changes observed
Dose 3000 mg/kg bw : no findings
Dose 10000 mg/kg bw : blue coloured skin
Dose 15000 mg/kg bw : no findings

Any other information on results incl. tables

Acute oral toxicity in the rat of Acid Blue 025

Dose
(mg/kg bw)
Concentration
(%)
mortality Bodyweight (g) Symptoms and necropsy
absolute day of test n pre-test on day 15 of test
m f
1000 10 0/5 0/5     86 182 After 30 min. hyperreflexia lasting >6 hours. After 24 hours no symptoms. At autopsy no gross organ changes were seen.
3000 30 0/5 0/5     84 179 Ditto, after 15 min. irregular respiration, reduction in spontaneous motility, muscular hypotonia. Symptoms lasting >24 hours. After 3 days no symptoms,
10000 25 0/5 0/5     80 175 Ditto, stiff movements, piloerection. At autopsy, blue-coloured skin.
15000 25 0/5 0/5     82 177 ditto, laboured respiration, ataxia. Symptoms lasting >5 days. After 7 days no symptoms.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 15000 mg/kg bw
Executive summary:

The substance has been tested in rat of both sexes. The animals were observed over a period of 15 days after a single administration of the test item (1000, 3000, 10000 and 15000 mg/kg bw) by oral intubation. The test substance shows a LD50 > 15000 mg/kg bw therefore is relatively innocuous to the rat by oral administration. No mortality was observed during the test period.