Registration Dossier
Registration Dossier
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EC number: 701-479-5 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The test substance registered was evaluated to be of low acute and systemic toxictiy. A read across approach is used to fill the data gap for subchronic toxicity. The read-across to PGPR is justifed as both chemicals are of comparable structures. They can be characterized as esters of polyglycerol and fatty acids and undergo the same metabolism (Refer to “Read Across Justification” presented in Section 13).
Further, the anlogue substance (source substance) PGPR is well assessed as food additive [FAC (1992) Food Advisory Committee Report on the Review of the Emulsifiers and Stabilisers in Food Regulations FdAC/REP/11. pp. 1-71. HMSO, London;GRAS Notification 009 (1998) and 179 (2006)and GRAS notice 000270: polyricinoleic acid (GRN PGPR 11-21 08)]. The Joint FAO/WHO Expert Committee on Food Additives (JECFA 17th report) set the ADI for PGPR of 7.5 mg/kg body weight (in: World Health Organization Technical Report Series 1974, No. 539 (246-253) ; FAO Nutrition Meetings Report Series, 1974, No. 53). Based on the similar structure and the same metabolism of both the target and source chemical (refer to Section 13: “Justification for Read Across”) and taken all the available data on acute and repeated dose toxicity with both the target and the source chemical together, it is considered that the target substance is of low toxicity. The NOAEL for repeated dosing is determined to be 2000 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The test substance registered was evaluated to be of low acute and systemic toxictiy. A read across approach is used to fill the data gap for subchronic toxicity and reproduction toxicity. The read-across to PGPR is justifed as both chemicals are of comparable structures. They can be characterized as esters of polyglycerol and fatty acids and undergo the same metabolism (Refer to “Read Across Justification” presented in Section 13).
Further, the anlogue substance (source substance) PGPR is well assessed as food additive [FAC (1992) Food Advisory Committee Report on the Review of the Emulsifiers and Stabilisers in Food Regulations FdAC/REP/11. pp. 1-71. HMSO, London;GRAS Notification 009 (1998) and 179 (2006)and GRAS notice 000270: polyricinoleic acid (GRN PGPR 11-21 08)]. The Joint FAO/WHO Expert Committee on Food Additives (JECFA 17th report) set the ADI for PGPR of 7.5 mg/kg body weight. (in: World Health Organization Technical Report Series 1974, No. 539 (246-253) ; FAO Nutrition Meetings Report Series, 1974, No. 53). Based on the similar structure and the same metabolism of both the target and source chemical (refer to Section 13: “Justification for Read Across”) and taken all the available data on acute and repeated dose toxicity with both the target and the source chemical together, it is considered that the target substance is of low toxicity. The NOAEL for repeated dosing is determined to be 2000 mg/kg bw/day.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
