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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
Body weights not recorded.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
EC Number:
230-303-5
EC Name:
Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
Cas Number:
7023-61-2
Molecular formula:
C18H13ClN2O6S.Ca
IUPAC Name:
calcium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
Test material form:
solid: nanoform
Details on test material:
- 95% C. I. Pigment Red 48 - Calcium Salt
- 5% modified wood rosin derivative
- A red powder labelled PD 1201 EG 9146

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:
- 95% C. I. Pigment Red 48 - Calcium Salt
- 5% modified wood rosin derivative
- A red powder labelled PD 1201 EG 9146

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rats were caged singly and kept in a room maintained at a temperature of 21°C (+2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Water was available at all times.

Animals: Healthy Sprague-Dawley derived rats, bred on the premises, aged 6 - 7 weeks, having an average body weight of 176 g (males)
and 142 g ( females )

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
50% aqueous solution
Details on oral exposure:
Rats had been fasted for 18 h prior to dosing at a rate of 20 mL/kg.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Mortality:
none
Clinical signs:
other: no adverse findings
Gross pathology:
no adverse findings
Other findings:
In all animals the faeces were stained red for approximately 48 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met