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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Vat Blue 014 - Similar Substance 01
IUPAC Name:
Vat Blue 014 - Similar Substance 01
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
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Weight at study initiation: 105 to 120 g
- Fasting period before study: overnight
- Housing: 5/cage
- Diet ad libitum: No 890 Nafag Gossau SG
- Water (e.g. ad libitum): tap
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
2%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% (1000 mg/kg), 30% (3000 mg/kg), 25% (10000 and 15000 mg/kg)
- Amount of vehicle (if gavage): 10 ml/kg (1000 and 3000 mg/kg), 40 ml/kg (10000 mg/kg), 60 ml/kg (15000 mg/kg)
Doses:
1000, 3000, 10000, 15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of weighing: Days 1 and 15
- Clinical signs and mortality: throughout observation period

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 15 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
1000 mg/kg bw: none
3000 mg/kg bw: reduction in spontaneous motility, ataxia, muscular hypotonia with partial hypertonia, hyperreflexia. After 3 days no symptoms
10000 mg/kg bw: reduction in spontaneous motility, ataxia, muscular hypotonia with partial hypertonia, hyperreflexia, hypoventilation, ventricumbency. After 3 days no symptoms
15000 mg/kg bw:reduction in spontaneous motility, ataxia, muscular hypotonia with partial hypertonia, hyperreflexia, hypoventilation, ventricumbency, diarrhea, humpbacked. After 3 days no symptoms
Body weight:
no abnormalities

Applicant's summary and conclusion

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

The test substance did not cause any mortality up to 15000 mg/kg bw. The LD0 and LD50 is higher then 15000 mg/kg bw.