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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
see below

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 157-190 g
- Fasting period before study:
- Housing: 5/cage/sex
- Diet (e.g. ad libitum): NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 3, 1982 To: March 29, 1982

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
400
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 and 20 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
Doses:
300, 1000, 2500, 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:
Mortality: daily, a.m. and p.m. on working days
Signs and Symptoms: daily
Body weight: on days 1, 7, 14 and at death
- Necropsy of survivors performed: yes
Necropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
From the body weights, the group means and their standard deviations were calculated.
The LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39.357-65, 1944)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 004 mg/kg bw
Based on:
test mat.
Remarks:
API: 55.6%
95% CL:
>= 966 - <= 7 827
Sex:
female
Dose descriptor:
LD50
Effect level:
2 152 mg/kg bw
Based on:
test mat.
Remarks:
API: 55.6%
95% CL:
>= 660 - <= 82 457
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 120 mg/kg bw
Based on:
test mat.
Remarks:
API: 55.6%
95% CL:
>= 1 279 - <= 4 373
Mortality:
No deaths occurred at 300 mg/kg bw.
At 1000 mg/kg bw, 1 male and 2 females died within two days.
At 2500 mg/kg bw, 2 males and 2 females died within two days.
At 5000 mg/kg bw, all males and 3 females died on Day 1; one further female died on Day 13.
Clinical signs:
Only signs of unspecific toxicity were observed at all dose levels, such as, sedation, dyspnoea, exaphthalmos, ruffled fur, curved body position
Body weight:
All surviving animals showed regular body weight development
Gross pathology:
No compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
calculated for 100% API
Executive summary:

Upon a acute oral administration and a 14 day post-treatment observation period, the following lethal doses (with 95 % confidence limits) were

determined for Basic Blue 41 Cl (purity 55.6%).

LD50 in male rats: 2004 (966-7827) mg/kg bw.

LD50 in female rats: 2152 (660-82457) mg/kg bw.

LD50 in rats of both sexes: 2120(1279-4373) mg/kg bw.

Signs of unspecitic toxicity were seen at all dose levels.

According to the company standard Basic Blue 41 has a slight acute toxicity when administered orally to the albino rat.

Calculated for 100% API, the LD50 lies between 300 and 2000 mg/kg bw, and hence results in classification in Category 4 based on GHS CLP criteria.