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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

LD50(oral) > 15000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 1977
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
no guideline available
Principles of method if other than guideline:
Similar to OECD Guideline 401 (Acute Oral Toxicity) with slight deviations (Cycle dark/light 14 hours).
GLP compliance:
pre GLP
Test type:
standard acute method
Limit test:
other: Tif: RAIf
Details on test animals or test system and environmental conditions:
- 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

- Temperature (°C): 22 ±1 °C
- Humidity (%): 55 ±5 %
- Photoperiod (hrs dark / hrs light): Cycle light/dark 14 hs
Route of administration:
oral: gavage
CMC (carboxymethyl cellulose)
Details on oral exposure:
- Concentration in vehicle: 10 %, 30 %, 25 %
1000, 3000, 10000 and 15000 mg/kg bw
No. of animals per sex per dose:
5 rats per sex per dose
Control animals:
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:
Dose descriptor:
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
No mortality observed
Clinical signs:
other: 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
Gross pathology:
Dose 1000 mg/kg bw : no gross organ changes observed
Other findings:
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

Acute oral toxicity in the rat of Acid Blue 025

(mg/kg bw)
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.
Interpretation of results:
other: CLP criteria not met
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
15 000 mg/kg bw
Quality of whole database:
Method equivalent or similar to guidelines internationally accepted.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The substance was tested in 1977 by oral administration. The results of the test show a very high value of LD50. No death occurred during the test.

Justification for classification or non-classification

According to the CLP Regulation (EC) n. 1272/2008, acute toxicity means those adverse effects occurring following oral or dermal administration of a single dose of a substance or a mixture, or multiple doses given within 24 hours, or an inhalation exposure of 4 hours.

The substance is not classified according to table 3.1.1 of the CLP Regulation (EC) n. 1272/2008.