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Toxicological information

Carcinogenicity

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Description of key information

Key value for chemical safety assessment

Carcinogenicity: via oral route

Link to relevant study records
Reference
Endpoint:
carcinogenicity: oral
Remarks:
- In fact a chronic toxicity study similar to OECD TG 452 is used here for a partial assessment of carcinogenicity.
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
As explained in a separate document (Read Across Justification, Sadler, 2017; attached to this dossier, Chapter 13) both paraffin oils, sulfochlorinated, saponified and the read across substance are very similarly composed secondary alkane sulfonates (UVCBs); slight differences are caused by the production processes - for the paraffin oils, sulfochlorinated, saponified the sulfochlorination and for the read across substance the sulfoxidation. A comparative assessment of the available toxicological informations confirms that there is no reason to deviate from the read across approach from a toxicological view. This assessment is contained in a separate document (Supporting information on human health assessment, Karthaus, 2017; attached to this dossier, Chapter 13).

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Informations given in (a) Read Across Justification, Sadler, 2017 and (b) Supporting information on human health assessment, Karthaus, 2017, both attached to this dossier, Chapter 13.

3. ANALOGUE APPROACH JUSTIFICATION
Informations given in (a) Read Across Justification, Sadler, 2017 and (b) Supporting information on human health assessment, Karthaus, 2017, both attached to this dossier, Chapter 13.

4. DATA MATRIX
Informations given in (a) Read Across Justification, Sadler, 2017 and (b) Supporting information on human health assessment, Karthaus, 2017, both attached to this dossier, Chapter 13.
Reason / purpose:
read-across source
Dose descriptor:
NOAEL
Remarks:
General toxicity
Effect level:
ca. 200 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
clinical signs
body weight and weight gain
Dose descriptor:
NOAEL
Remarks:
Carcinigenicity
Effect level:
ca. 1 000 mg/kg bw/day (nominal)
Based on:
act. ingr.
Sex:
male/female
Basis for effect level:
other: No macroscopic or microscopic effect observed at any dose tested.
Critical effects observed:
no
Executive summary:

Based on read across this result of a chronic feeding is relevant for paraffin oils, sulfochlorinated, saponified. As explained in a separate document (Read Across Justification, Sadler, 2017; attached to this dossier, Chapter 13) both paraffin oils, sulfochlorinated, saponified and the read across substance are very similarly composed secondary alkane sulfonates (UVCBs); slight differences are caused by the production processes - for the paraffin oils, sulfochlorinated, saponified the sulfochlorination and for the read across substance the sulfoxidation. A comparative assessment of the available toxicological informations confirms that there is no reason to deviate from the read across approach from a toxicological view. This assessment is also contained in a separate document (Supporting information on human health assessment, Karthaus, 2017; attached to this dossier, Chapter 13).

Here in brief is the result of the chronic feeding study with the read across substance with repsect to carcinogenicity (for other toxicity results see chapter Repeated dose toxicity):

A chronic feeding study similar to OECD TG 452, but conducted at a time before the guideline was available, investigated the chronic toxicity of the substance (test material was as aqueous slurry with 60 % active ingredient; all concentrations quoted here are in terms of the active ingredient). This information is used for a partial assessment of carcinogenicity.

In the study groups of 20 male and 20 female rats were fed diets containing 0.08, 0.4 and 2.0 % (w/w) test substance for 52 weeks (approximate doses 40, 200 and 1000 mg/kg bw and day). A similar sized group received plain diet and served as control. For each dose additional 10 male and 10 female sentinel animals were used for interim pathological examination (terminated after 26 weeks of treatment).

For results with respect to general toxicity see chapter on repeated dose. With respect to carcinogencity it can be stated based on the chronic study that non-neoplastic and neoplastic pathology was unchanged by the chronic treatment.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
chronic
Species:
rat

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Based on read across a chronic feeding study is available for the assessment of paraffin oils, sulfochlorinated, saponified. This study similar to OECD TG 452, but conducted at a time before the guideline was available, investigated the chronic toxicity of the read across substance

(test material was as aqueous slurry with 60 % active ingredient; all concentrations quoted here are in terms of the active ingredient), but can also partially be used for assessment on carcinogenicity.

In the study groups of 20 male and 20 female rats were fed diets containing 0.08, 0.4 and 2.0 % (w/w) test substance for 52 weeks (approximate doses 40, 200 and 1000 mg/kg bw and day). A similar sized group received plain diet and served as control. For each dose additional 10 male and 10 female sentinel animals were used for interim pathological examination (terminated after 26 weeks of treatment).

For results with respect to general toxicity see chapter on repeated dose. With respect to carcinogencity it can be stated based on the chronic study that non-neoplastic and neoplastic pathology was not affected by the chronic treatment at any dose investigated.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008, Annex I, no classification is required for carcinogenicity.