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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
non GLP, no necropsy performed. Little information on test item

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
higher doses and more animals, only 8 days post-observation.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1)
EC Number:
239-879-2
EC Name:
Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1)
Cas Number:
15782-05-5
Molecular formula:
C18H13ClN2O6S.Sr
IUPAC Name:
strontium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
- Test substance was present in a mixture
- Manufacture date: 6.8.71
- Company identifier: TK 10340
- Product containing mainly the sodium salt of pigment red 48. The content of Pigment red 48:3 is 29%.

Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Specific details on test material used for the study:
- Test substance was present in a mixture
- Manufacture date: 6.8.71
- Company identifier: TK 10340
- Product containing mainly the sodium salt of pigment red 48. The content of Pigment red 48:3 is 29%.

Test animals

Species:
rat
Strain:
other: CFE
Sex:
male/female
Details on test animals or test system and environmental conditions:
Healthy young random bred rats of the CFE (RAC, SPF) strain purchased from the breeder were used for these experiments. The mean initial body weight was between 127 and 138 g. Before starting, the animals were acclimatized for at least 5 days in our laboratories to a constant room temperature of 22°C, relative humidity of 55 % and 14 hours light/day. They were housed in groups of 5 in macrolon cages (size 3). A standard diet of Nafag and drinking water were given "ad libitum".

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
Rats received by gavage various doses of a preparation suspended with 0.5% carboxymethyIcellulose and tap water. The total volume given was 20 mL/kg body weight.
Doses:
5000 and 10000 mg/kg bw (containing 2900 mg/kg bw of Pigment Red 48:3)
No. of animals per sex per dose:
- 5000 mg/kg bw: 5/sex
- 10000 mg/kg bw: 3 males and 2 females
Control animals:
no
Details on study design:
Symptoms and mortality after administration were recorded during an observation period of 8 days.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 900 mg/kg bw
Remarks on result:
other: calculated on content of Pigment Red 48:3
Gross pathology:
not performed
Other findings:
- Other observations: red stained feces at both doses, red stained urine at 10000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met