Registration Dossier
Registration Dossier
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EC number: 285-077-0 | CAS number: 85029-52-3
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:
- low hazard (no threshold derived)
Additional information - workers
Hazard via inhalation route
In accordance with the column 2 adaptation of column 1, REACH Annex VIII, the acute dermal toxicity study (required in section 8.5.2) is not considered scientifically justified as the oral and dermal exposure routes are the most appropriate to assess the acute toxicity hazard presented by the substance based on its physico-chemical characteristics and use pattern.
Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the inhalation route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.
Hazard via dermal route
In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute dermal toxicity. Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the dermal route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.Skin irritation: As Acacia Mearnsi did not induce any skin irritation effects, it does not need to be classified according to classification of Reg. 1272/2008/EC
Hazard via oral route
In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute oral toxicity.
The repeated dose administration of the Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde according to the 422 OECD guidance, to Wistar rats at different dosages revealed neither mortalities nor findings of toxicological relevance in animals. Based on these results, according to the 1272/2008/EC the substance shouldn't need to be classified.
Hazard to the eyes
Due to the irritation Index and the reversibility of the irritation observed after 14 days (Study report from Eunice Mayumi Suenaga, 1998), Acacia Mearnsi is classified as Eye irritant Cat. 2 according to classification criteria of 1272/2008/EC.
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:
- low hazard (no threshold derived)
Additional information - General Population
Hazard via inhalation route
In accordance with the column 2 adaptation of column 1, REACH Annex VIII, the acute dermal toxicity study (required in section 8.5.2) is not considered scientifically justified as the oral and dermal exposure routes are the most appropriate to assess the acute toxicity hazard presented by the substance based on its physico-chemical characteristics and use pattern.
Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the inhalation route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.
Hazard via dermal route
In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute dermal toxicity.Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the dermal route does not need to be conducted if the study does not appear to be scientifically necessary. An oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) already sufficiently addresses the repeat dose toxicity data requirements.Skin irritation: As Acacia Mearnsi did not induce any skin irritation effects, it does not need to be classified according to classification of Reg. 1272/2008/EC
Hazard via oral route
In accordance with the criteria for classification as defined in the annex I of the Regulation 1272/2008/EC, the test material does not meet the criteria for classification for acute oral toxicity.
The repeated dose administration of the Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde according to the 422 OECD guidance, to Wistar rats at different dosages revealed neither mortalities nor findings of toxicological relevance in animals. Based on these results, according to the 1272/2008/EC the substance shouldn't need to be classified.
Hazard to the eyes
Due to the irritation Index and the reversibility of the irritation observed after 14 days (Study report from Eunice Mayumi Suenaga, 1998), Acacia Mearnsi is classified as Eye irritant Cat. 2 according to classification criteria of 1272/2008/EC.
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.
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