Registration Dossier

Administrative data

Description of key information

Experimental data on acute toxicity of Pigment Red 52 -Sr are not available. Results from a members of the same category indicate that Pigment Red 52 -Sr is not acutely toxic via the oral, inhalation, and dermal route of exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please see the category read-across justification in the category object.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Based on:
other: read-across
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 400 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please see the category read-across justification in the category object.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 518 mg/m³ air
Based on:
other: read-across
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.76 mg/L air
Based on:
other: read-across
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1 518 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Please see the category read-across justification in the category object.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
other: read-across
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 500 mg/kg bw

Additional information

Acute oral toxicity

No experimental data is available for Pigment Red 52-Sr, however sufficient data on acute toxicity is available for other substances in the category. The analogue pigments for which acute oral toxicity data is available (48:1, 48:2, 48:3, 48:4, 57:1, and 57:Sr) are all of low acute oral toxicity (LD50 >2000 mg/kg bw). The difference between these pigments and Pigment Red 52 -Sr is a small difference in the structure of the sulfonated amine. These differences are not relevant for acute oral toxicity because the sulfonated amine of Pigment Red 52-Sr (CAS 88 -53 -9) is of low acute oral toxicity.

 

Acute inhalation toxicity

The hazard of acute inhalation toxicity is derived from experimental data on analogue pigments present in the category. A valid study is available for Pigment Red 57:1 which differs from Pigment Red 52 -Sr by the absence of a chlorine on the sulfonated aromatic amine moiety and containing Sr2 + instead of Ba2 +. In addition, a valid study is available for Pigment Red 48:1 which contains Ba2+ instead of Sr2 +. Acute inhalation exposure to aerosol of Pigment Red 48:1 at a concentration of 4.76 mg/L caused mortality in one of ten rats (Capelle 1993) as assessed in a GLP compliant study following OECD testing guideline 403. The study with Pigment Red 57:1 (Sachsse 1976) was performed in rats with a commercial product following a protocol which is comparable to OECD testing guideline 403 (1981). A limit test was performed with the highest concentration of dust that was technically achievable (1518 ± 176 mg/m3 air). No mortality, no clinical signs and no findings upon necropsy were observed.

 

Acute dermal toxicity

The hazard of acute dermal toxicity is derived from experimental data on analogue pigments (48:1, 48:2, 48:3, and 57:1) present in the category. For these pigments, the LD50s all exceeded 2500 mg/kg bw. As a result, it can be concluded that Pigment Red 52:1 is also not acutely toxic via the dermal route.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute oral, dermal or inhalation toxicity according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.